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

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 276 83905-01-5

Description:

MoleculeDescription

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

Drug dosage:

DoseUnitRoute
0.30 g O
0.50 g P

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
Nov. 1, 1991 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 13.45 acidic
pKa2 8.87 Basic
pKa3 8.24 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Canalicular multispecific organic anion transporter 1 Transporter IC50 4.16 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 3.70 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 3.39 WOMBAT-PK
Motilin receptor GPCR AGONIST EC50 5.50 IUPHAR
SARS-CoV-2 Virus INHIBITOR EC50 5.67 SCIENTIFIC LITERATURE

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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