azithromycin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, produced by Streptomyces strains	276	83905-01-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: CP-62993 CP 62993 azithromycin arzomicin aziromycin Azithromycin A azithromycin monohydrate azithromycin anhydrous azithromycin dihydrate azithromycin hydrate	A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis. Molecular weight: 749.00 Formula: C38H72N2O12 CLOGP: 2.64 LIPINSKI: 2 HAC: 14 HDO: 5 TPSA: 180.08 ALOGS: -3.16 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

CP-62993
CP 62993
azithromycin
arzomicin
aziromycin
Azithromycin A
azithromycin monohydrate
azithromycin anhydrous
azithromycin dihydrate
azithromycin hydrate

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Molecular weight: 749.00
Formula: C38H72N2O12
CLOGP: 2.64
LIPINSKI: 2
HAC: 14
HDO: 5
TPSA: 180.08
ALOGS: -3.16
ROTB: 7

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.50	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	39 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	6 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	44.50 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	34 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	33 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.88 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	69 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Nov. 1, 1991	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	4480.92	26.05	1139	2472	45504	2308970
No adverse event	424.64	26.05	132	3479	9396	2345078
Rash	396.45	26.05	209	3402	59349	2295125
Product quality issue	308.32	26.05	107	3504	10722	2343752
Product packaging quantity issue	283.76	26.05	52	3559	338	2354136
Product dose omission	244.18	26.05	131	3480	38126	2316348
Vomiting	230.77	26.05	158	3453	71444	2283030
Urticaria	221.71	26.05	106	3505	24155	2330319
Nausea	199.86	26.05	174	3437	112015	2242459
Drug-induced liver injury	197.41	26.05	59	3552	3640	2350834
Diarrhoea	188.98	26.05	149	3462	83415	2271059
Anosmia	181.05	26.05	41	3570	831	2353643
Stevens-Johnson syndrome	168.43	26.05	54	3557	4205	2350269
Inappropriate schedule of product administration	161.03	26.05	69	3542	12135	2342339
Drug interaction	147.80	26.05	86	3525	29077	2325397
Pyrexia	145.78	26.05	107	3504	53601	2300873
Ageusia	142.72	26.05	40	3571	1958	2352516
Pruritus	142.23	26.05	97	3514	43243	2311231
Electrocardiogram QT prolonged	136.40	26.05	54	3557	7760	2346714
Drug ineffective	132.84	26.05	133	3478	101491	2252983
Dyspnoea	131.33	26.05	118	3493	78615	2275859
Hypersensitivity	112.65	26.05	67	3544	23526	2330948
Torsade de pointes	111.89	26.05	34	3577	2212	2352262
Deafness	109.83	26.05	35	3576	2666	2351808
Cardiac arrest	105.78	26.05	55	3556	14875	2339599
Tinnitus	98.43	26.05	38	3573	5097	2349377
Eye irritation	96.96	26.05	34	3577	3478	2350996
Erythema	88.76	26.05	59	3552	25100	2329374
Malaise	87.88	26.05	81	3530	55504	2298970
Abdominal pain	85.22	26.05	65	3546	34309	2320165
Ventricular fibrillation	83.24	26.05	27	3584	2174	2352300
Acute kidney injury	80.50	26.05	58	3553	28064	2326410
Incorrect product administration duration	75.99	26.05	26	3585	2469	2352005
Ocular hyperaemia	74.11	26.05	29	3582	4027	2350447
International normalised ratio increased	69.63	26.05	33	3578	7303	2347171
Drug reaction with eosinophilia and systemic symptoms	68.73	26.05	30	3581	5488	2348986
Product prescribing error	67.93	26.05	25	3586	2935	2351539
Chills	65.99	26.05	41	3570	15511	2338963
Pneumonia	64.89	26.05	65	3546	49231	2305243
Ventricular tachycardia	63.86	26.05	24	3587	2987	2351487
Toxic epidermal necrolysis	62.85	26.05	24	3587	3120	2351354
Alanine aminotransferase increased	62.09	26.05	38	3573	13994	2340480
Abdominal discomfort	61.65	26.05	41	3570	17415	2337059
Dizziness	60.62	26.05	68	3543	58597	2295877
Hepatocellular injury	60.29	26.05	25	3586	4030	2350444
Anaphylactic shock	58.95	26.05	25	3586	4261	2350213
Aspartate aminotransferase increased	57.97	26.05	35	3576	12577	2341897
Seizure	57.79	26.05	45	3566	24421	2330053
Palpitations	56.54	26.05	38	3573	16418	2338056
Cough	55.61	26.05	50	3561	33067	2321407
Condition aggravated	53.13	26.05	48	3563	31931	2322543
Syncope	50.97	26.05	36	3575	16839	2337635
Eye pain	49.48	26.05	23	3588	4868	2349606
Tachycardia	47.24	26.05	34	3577	16375	2338099
Hypoacusis	47.17	26.05	20	3591	3405	2351069
Eye swelling	45.51	26.05	21	3590	4369	2350105
Erythema multiforme	44.89	26.05	17	3594	2158	2352316
Hypotension	44.89	26.05	44	3567	32392	2322082
Medication error	44.54	26.05	23	3588	6108	2348366
Abdominal pain upper	44.42	26.05	37	3574	22063	2332411
Bradycardia	44.05	26.05	27	3584	9954	2344520
Pharyngeal oedema	43.51	26.05	19	3592	3474	2351000
Loss of consciousness	43.17	26.05	34	3577	18733	2335741
Pancytopenia	43.09	26.05	28	3583	11424	2343050
Anaphylactic reaction	42.19	26.05	26	3585	9679	2344795
Weight decreased	42.10	26.05	40	3571	28331	2326143
Throat tightness	39.17	26.05	19	3592	4417	2350057
Toxicity to various agents	39.05	26.05	41	3570	32713	2321761
Hepatitis cholestatic	38.93	26.05	13	3598	1144	2353330
Lip oedema	38.62	26.05	12	3599	839	2353635
Angioedema	37.78	26.05	23	3588	8373	2346101
Blood alkaline phosphatase increased	37.58	26.05	21	3590	6524	2347950
Palmar erythema	37.46	26.05	9	3602	237	2354237
Liver injury	36.88	26.05	15	3596	2299	2352175
Monoclonal gammopathy	36.84	26.05	8	3603	132	2354342
Aphthous ulcer	36.34	26.05	13	3598	1405	2353069
Tremor	36.24	26.05	32	3579	20629	2333845
Cholestasis	36.09	26.05	17	3594	3704	2350770
Pallor	36.00	26.05	17	3594	3725	2350749
Cardio-respiratory arrest	35.97	26.05	23	3588	9123	2345351
Hypoxic-ischaemic encephalopathy	35.51	26.05	11	3600	761	2353713
Deafness neurosensory	34.85	26.05	10	3601	531	2353943
Hepatic failure	34.71	26.05	19	3592	5670	2348804
Adjustment disorder	34.54	26.05	8	3603	179	2354295
Rhabdomyolysis	34.43	26.05	20	3591	6684	2347790
Paraesthesia	34.40	26.05	32	3579	22056	2332418
Respiratory failure	34.35	26.05	26	3585	13502	2340972
Burning sensation	34.09	26.05	21	3590	7807	2346667
Agranulocytosis	34.05	26.05	16	3595	3466	2351008
Rash maculo-papular	33.93	26.05	17	3594	4235	2350239
Actinic keratosis	33.48	26.05	9	3602	375	2354099
Asthenia	33.18	26.05	45	3566	46881	2307593
Vision blurred	32.49	26.05	26	3585	14642	2339832
Cyanosis	32.27	26.05	15	3596	3170	2351304
Swelling	32.06	26.05	27	3584	16323	2338151
Insomnia	32.01	26.05	33	3578	25754	2328720
Drug eruption	31.94	26.05	15	3596	3244	2351230
Bronchitis	31.86	26.05	25	3586	13689	2340785
Ototoxicity	31.62	26.05	8	3603	262	2354212
Hyperhidrosis	31.34	26.05	26	3585	15396	2339078
Sacroiliitis	31.22	26.05	8	3603	276	2354198
White blood cell count increased	30.85	26.05	19	3592	7059	2347415
Acute generalised exanthematous pustulosis	30.78	26.05	12	3599	1646	2352828
Headache	30.59	26.05	58	3553	80121	2274353
Dermatitis exfoliative	30.39	26.05	11	3600	1230	2353244
Hepatitis	30.16	26.05	18	3593	6319	2348155
Wheezing	30.04	26.05	18	3593	6366	2348108
Atrophy	29.79	26.05	8	3603	332	2354142
Sinusitis	29.78	26.05	26	3585	16500	2337974
Conjunctivitis	29.75	26.05	13	3598	2380	2352094
Back pain	29.74	26.05	35	3576	31624	2322850
Drug intolerance	29.71	26.05	24	3587	13693	2340781
Hemianopia heteronymous	29.28	26.05	5	3606	20	2354454
Foetal death	29.13	26.05	12	3599	1900	2352574
Bundle branch block left	28.96	26.05	10	3601	974	2353500
Hepatitis acute	28.11	26.05	11	3600	1524	2352950
Chromaturia	28.00	26.05	13	3598	2740	2351734
Pyloric stenosis	27.52	26.05	6	3605	101	2354373
Coagulopathy	27.32	26.05	13	3598	2896	2351578
Ear discomfort	27.19	26.05	10	3601	1170	2353304
Eosinophilia	27.06	26.05	13	3598	2957	2351517
Hallucination, visual	27.02	26.05	13	3598	2966	2351508
Laryngeal oedema	26.33	26.05	10	3601	1278	2353196
Tubulointerstitial nephritis	26.32	26.05	12	3599	2426	2352048
Hepatic steatosis	26.09	26.05	13	3598	3200	2351274

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	705.16	29.83	217	2038	14918	1729608
No adverse event	329.14	29.83	95	2160	5087	1739439
Drug interaction	249.67	29.83	121	2134	27837	1716689
Rash	215.29	29.83	122	2133	38571	1705955
Product quality issue	205.92	29.83	69	2186	6024	1738502
Product packaging quantity issue	193.13	29.83	36	2219	251	1744275
Vomiting	150.98	29.83	97	2158	38218	1706308
Product dose omission	138.50	29.83	76	2179	22364	1722162
Stevens-Johnson syndrome	137.39	29.83	44	2211	3313	1741213
Diarrhoea	134.31	29.83	103	2152	53749	1690777
Rhabdomyolysis	119.88	29.83	55	2200	11035	1733491
Pruritus	119.87	29.83	70	2185	23152	1721374
Electrocardiogram QT prolonged	115.78	29.83	44	2211	5501	1739025
International normalised ratio increased	114.95	29.83	49	2206	8250	1736276
Dyspnoea	113.34	29.83	92	2163	51967	1692559
Urticaria	111.66	29.83	54	2201	12187	1732339
Pyrexia	107.31	29.83	85	2170	46315	1698211
Inappropriate schedule of product administration	106.47	29.83	45	2210	7414	1737112
Vanishing bile duct syndrome	94.65	29.83	18	2237	141	1744385
Drug-induced liver injury	90.98	29.83	32	2223	3205	1741321
Abdominal pain	90.72	29.83	57	2198	21433	1723093
Deafness	89.62	29.83	28	2227	1938	1742588
Pneumonia	88.67	29.83	76	2179	46106	1698420
Nausea	85.82	29.83	78	2177	51118	1693408
Cholestasis	79.76	29.83	30	2225	3635	1740891
Drug eruption	78.69	29.83	28	2227	2898	1741628
Jaundice	77.98	29.83	34	2221	6028	1738498
Condition aggravated	74.25	29.83	50	2205	21100	1723426
Hypersensitivity	71.52	29.83	38	2217	10406	1734120
Cough	71.27	29.83	47	2208	19150	1725376
Hepatomegaly	68.51	29.83	22	2233	1663	1742863
Skin exfoliation	66.77	29.83	28	2227	4507	1740019
Aspartate aminotransferase increased	64.92	29.83	36	2219	10720	1733806
Alanine aminotransferase increased	63.11	29.83	37	2218	12241	1732285
Viral infection	56.95	29.83	22	2233	2861	1741665
Clostridium difficile colitis	53.36	29.83	18	2237	1586	1742940
Prothrombin level decreased	52.54	29.83	12	2243	244	1744282
Angioedema	51.96	29.83	30	2225	9634	1734892
Tinnitus	51.32	29.83	21	2234	3174	1741352
Drug ineffective	51.29	29.83	66	2189	63735	1680791
Tubulointerstitial nephritis	49.42	29.83	20	2235	2938	1741588
Torsade de pointes	48.59	29.83	16	2239	1308	1743218
Drug reaction with eosinophilia and systemic symptoms	48.03	29.83	23	2232	5047	1739479
Incorrect product administration duration	47.94	29.83	15	2240	1040	1743486
Ventricular tachycardia	47.82	29.83	21	2234	3777	1740749
Cardiac arrest	47.25	29.83	34	2221	15896	1728630
Loss of consciousness	47.00	29.83	33	2222	14842	1729684
Bacterial infection	46.61	29.83	17	2238	1885	1742641
Acute kidney injury	46.49	29.83	47	2208	34897	1709629
Hepatitis	45.48	29.83	22	2233	4933	1739593
Anosmia	45.24	29.83	12	2243	460	1744066
Palpitations	44.37	29.83	24	2231	6790	1737736
Off label use	44.37	29.83	48	2207	38523	1706003
Mycobacterium avium complex infection	44.16	29.83	11	2244	327	1744199
Weight decreased	42.54	29.83	37	2218	22716	1721810
Leukopenia	42.08	29.83	25	2230	8455	1736071
Blood creatine phosphokinase increased	41.07	29.83	25	2230	8831	1735695
Eye irritation	39.88	29.83	14	2241	1389	1743137
Haemolytic anaemia	39.60	29.83	15	2240	1847	1742679
Toxic epidermal necrolysis	39.49	29.83	16	2239	2355	1742171
Pseudomembranous colitis	39.44	29.83	11	2244	510	1744016
Product prescribing error	39.24	29.83	16	2239	2394	1742132
Erythema	39.15	29.83	29	2226	14159	1730367
Rash maculo-papular	38.75	29.83	18	2237	3685	1740841
Blood alkaline phosphatase increased	38.64	29.83	20	2235	5175	1739351
Hepatocellular injury	37.89	29.83	17	2238	3214	1741312
Chromaturia	37.77	29.83	16	2239	2634	1741892
Multiple organ dysfunction syndrome	37.58	29.83	24	2231	9218	1735308
Swollen tongue	36.88	29.83	16	2239	2792	1741734
Hepatitis cholestatic	36.85	29.83	13	2242	1308	1743218
Hepatic failure	36.23	29.83	20	2235	5883	1738643
Hypotension	35.99	29.83	38	2217	29616	1714910
Hepatic function abnormal	35.46	29.83	21	2234	7053	1737473
Blood bilirubin increased	35.29	29.83	20	2235	6190	1738336
Bronchitis	34.99	29.83	19	2236	5413	1739113
Transaminases increased	34.76	29.83	17	2238	3900	1740626
Ageusia	34.63	29.83	13	2242	1561	1742965
Respiratory failure	34.19	29.83	27	2228	14478	1730048
Hepatic enzyme increased	34.09	29.83	20	2235	6601	1737925
Erythema multiforme	33.32	29.83	13	2242	1733	1742793
Agranulocytosis	33.18	29.83	16	2239	3560	1740966
Tachycardia	33.02	29.83	25	2230	12603	1731923
Activated partial thromboplastin time prolonged	33.00	29.83	12	2243	1318	1743208
Renal failure	32.35	29.83	30	2225	19987	1724539
Uveitis	31.84	29.83	11	2244	1040	1743486
Decreased appetite	31.49	29.83	32	2223	23839	1720687
Hyperhidrosis	31.06	29.83	24	2231	12464	1732062
Visual field defect	30.82	29.83	11	2244	1145	1743381
Ventricular fibrillation	30.72	29.83	14	2241	2742	1741784
Dermatitis bullous	30.20	29.83	11	2244	1213	1743313

Pharmacologic Action:

Source	Code	Description
ATC	J01FA10	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS Macrolides
ATC	J01RA07	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE COMBINATIONS OF ANTIBACTERIALS Combinations of antibacterials
ATC	S01AA26	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Antibiotics
FDA EPC	N0000175935	Macrolide Antimicrobial
FDA Chemical/Ingredient	N0000007529	Macrolides
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Acute gonococcal cervicitis	indication	20943002	DOID:10615
Acute gonococcal urethritis	indication	29864006
Streptococcal tonsillitis	indication	41582007
Pneumonia due to Mycoplasma pneumoniae	indication	46970008
Bacterial pneumonia	indication	53084003	DOID:874
Haemophilus influenzae pneumonia	indication	70036007
Acute bacterial sinusitis	indication	75498004
Bacterial conjunctivitis	indication	128350005	DOID:9700
Urethritis due to Chlamydia trachomatis	indication	179101003
Pulmonary Mycobacterium avium complex infection	indication	186342000
Chlamydial pelvic inflammatory disease	indication	188463006
Acute bacterial bronchitis	indication	233598009
Pneumococcal pneumonia	indication	233607000
Chlamydial pneumonia	indication	233609002
Chancroid	indication	266143009	DOID:13778
Pelvic inflammatory disease due to Mycoplasma hominis	indication	270550006
Streptococcus pyogenes infection	indication	302809008
Infective otitis media	indication	312218008
Infection due to Staphylococcus aureus	indication	406602003
Acute exacerbation of chronic bronchitis	indication	425748003
Pneumonia due to Staphylococcus aureus	indication	441658007
Moraxella Catarrhalis Acute Otitis Media	indication
Skin and Skin Structure Streptococcus Agalactiae Infection	indication
Chlamydia Cervicitis	indication
Legionella Pneumophila Pneumonia	indication
Pelvic Inflammatory Disease with Neisseria Gonorrhea	indication
Pneumococcal Acute Otitis Media	indication
Haemophilus Influenzae Acute Otitis Media	indication
Moraxella Catarrhalis Pneumonia	indication
Pyrexia of unknown origin	off-label use	7520000
Traveler's diarrhea	off-label use	11840006
Enteric campylobacteriosis	off-label use	18081009
Pertussis	off-label use	27836007
Gonorrhea of rectum	off-label use	42746002
Gonorrhea of pharynx	off-label use	74372003
Coronavirus infection	off-label use	186747009
Boutonneuse fever	off-label use	186774005	DOID:14095
Toxoplasmosis associated with acquired immunodeficiency syndrome	off-label use	421666009
Prevention of Bacterial Endocarditis	off-label use
Inflammatory Disease of Female Pelvic Organs	off-label use
Sexual Transmitted Disease Exposure from Sexual Assault	off-label use
Jaundice	contraindication	18165001
Torsades de pointes	contraindication	31722008
Chronic heart failure	contraindication	48447003
Myasthenia gravis	contraindication	91637004	DOID:437
Prolonged QT interval	contraindication	111975006
Hearing disorder	contraindication	128540005
Liver function tests abnormal	contraindication	166603001
Disease of liver	contraindication	235856003	DOID:409
Pseudomembranous enterocolitis	contraindication	397683000
Congenital long QT syndrome	contraindication	442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.45	acidic
pKa2	8.87	Basic
pKa3	8.24	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 2GM BASE/BOT	ZMAX	PF PRISM CV	N050797	June 10, 2005	DISCN	FOR SUSPENSION, EXTENDED RELEASE	ORAL	6984403	Feb. 14, 2024	METHOD OF TREATING BACTERIAL INFECTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source
Canalicular multispecific organic anion transporter 1	Transporter	Q92887	MRP2_HUMAN		IC50	4.16	WOMBAT-PK
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		IC50	3.70	WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	3.39	WOMBAT-PK
Motilin receptor	GPCR	O43193	MTLR_HUMAN	AGONIST	EC50	5.50	IUPHAR
SARS-CoV-2	Virus			INHIBITOR	EC50	5.67	SCIENTIFIC LITERATURE

External reference:

ID	Source
4020019	VUID
N0000148074	NUI
C0052796	UMLSCUI
D02134	KEGG_DRUG
5FD1131I7S	UNII
117772-70-0	SECONDARY_CAS_RN
96034006	SNOMEDCT_US
4020019	VANDF
72442	MMSL
003635	NDDF
18631	RXNORM
387531004	SNOMEDCT_US
4238	MMSL
d00091	MMSL
CHEMBL529	ChEMBL_ID
DB00207	DRUGBANK_ID
CHEMBL1200502	ChEMBL_ID
6197	INN_ID
ZIT	PDB_CHEM_ID
6510	IUPHAR_LIGAND_ID
D017963	MESH_DESCRIPTOR_UI
447043	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0400	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	17 sections
ZITHROMAX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3051	POWDER, FOR SUSPENSION	1 g	ORAL	NDA	18 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3060	TABLET, FILM COATED	250 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3070	TABLET, FILM COATED	500 mg	ORAL	NDA	17 sections
ZITHROMAX	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3080	TABLET, FILM COATED	600 mg	ORAL	NDA	18 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3110	POWDER, FOR SUSPENSION	100 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3120	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3130	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3140	POWDER, FOR SUSPENSION	200 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-3150	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-4061	TABLET, FILM COATED	250 mg	ORAL	NDA	17 sections
Zithromax	HUMAN PRESCRIPTION DRUG LABEL	1	0069-9500	TABLET, FILM COATED	250 mg	ORAL	UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE	19 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2026	POWDER, FOR SUSPENSION	200 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0093-2027	POWDER, FOR SUSPENSION	100 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0144	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	16 sections
azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0527-2370	TABLET, FILM COATED	250 mg	ORAL	ANDA	17 sections
azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0527-2395	TABLET, FILM COATED	500 mg	ORAL	ANDA	17 sections
Azithromycin Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	1	0527-2750	TABLET, COATED	500 mg	ORAL	Unapproved drug for use in drug shortage	2 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-1496	TABLET, FILM COATED	250 mg	ORAL	ANDA	19 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-1497	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-1941	TABLET, FILM COATED	500 mg	ORAL	ANDA	19 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5776	TABLET, FILM COATED	250 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5789	TABLET, FILM COATED	500 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-5793	TABLET, FILM COATED	600 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8089	TABLET, FILM COATED	250 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8090	TABLET, FILM COATED	500 mg	ORAL	ANDA	17 sections
Azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8091	TABLET, FILM COATED	600 mg	ORAL	ANDA	17 sections
Azithromycin Dihydrate	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6405	TABLET, FILM COATED	250 mg	ORAL	ANDA	19 sections
azithromycin monohydrate	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6708	TABLET	250 mg	ORAL	ANDA	17 sections
azithromycin	HUMAN PRESCRIPTION DRUG LABEL	1	10019-648	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA AUTHORIZED GENERIC	18 sections