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

Stem definition	Drug id	CAS RN
mucolytics	66	616-91-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: N-Acetylcysteine acetylcysteine acetadote acetilcysteina L-Acetylcysteine	The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates. N-Acetylcystene (NAC) as a precursor to the antioxidant glutathione modulates glutamatergic, neurotrophic, and inflammatory pathways. The potential applications of NAC to facilitate recovery after traumatic brain injury, cerebral ischemia, and in treatment of cerebrovascular vasospasm after subarachnoid hemorrhage. Molecular weight: 163.19 Formula: C5H9NO3S CLOGP: -0.62 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 66.40 ALOGS: -1.51 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

N-Acetylcysteine
acetylcysteine
acetadote
acetilcysteina
L-Acetylcysteine

The N-acetyl derivative of CYSTEINE. It is used as a mucolytic agent to reduce the viscosity of mucous secretions. It has also been shown to have antiviral effects in patients with HIV due to inhibition of viral stimulation by reactive oxygen intermediates. N-Acetylcystene (NAC) as a precursor to the antioxidant glutathione modulates glutamatergic, neurotrophic, and inflammatory pathways. The potential applications of NAC to facilitate recovery after traumatic brain injury, cerebral ischemia, and in treatment of cerebrovascular vasospasm after subarachnoid hemorrhage.

Molecular weight: 163.19
Formula: C5H9NO3S
CLOGP: -0.62
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 66.40
ALOGS: -1.51
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.60	g	Inhal.solution
0.50	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	61.28 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	5 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.55 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.17 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.50 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Sept. 14, 1963	FDA	APOTHECON

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
Body tinea	98.62	14.05	27	11537	1174	53336328
Infection susceptibility increased	82.63	14.05	28	11536	2509	53334993
Inhibitory drug interaction	77.45	14.05	26	11538	2264	53335238
Impaired quality of life	68.17	14.05	29	11535	4842	53332660
Glucose tolerance impaired	62.50	14.05	28	11536	5292	53332210
Chronic obstructive pulmonary disease	53.39	14.05	66	11498	61007	53276495
Bone density decreased	50.77	14.05	31	11533	11033	53326469
Stevens-Johnson syndrome	48.05	14.05	41	11523	24541	53312961
Acute hepatic failure	48.04	14.05	35	11529	16685	53320817
Rheumatoid arthritis	45.41	14.05	7	11557	314524	53022978
Purpura	43.73	14.05	28	11536	10825	53326677
Toxicity to various agents	42.58	14.05	124	11440	219474	53118028
Poor quality sleep	42.52	14.05	33	11531	17290	53320212
Toxic epidermal necrolysis	41.44	14.05	37	11527	23513	53313989
Tongue oedema	39.37	14.05	19	11545	4248	53333254
Metabolic acidosis	39.10	14.05	47	11517	42195	53295307
Hepatic encephalopathy	38.83	14.05	26	11538	10833	53326669
Overdose	37.15	14.05	76	11488	107660	53229842
Hyperlipidaemia	37.02	14.05	32	11532	19483	53318019
Oral herpes	34.76	14.05	32	11532	21147	53316355
Impaired work ability	32.76	14.05	26	11538	14064	53323438
Anaphylactoid reaction	32.58	14.05	16	11548	3715	53333787
Hepatotoxicity	32.55	14.05	35	11529	27845	53309657
Thrombocytopenia	31.46	14.05	83	11481	138644	53198858
Drug-induced liver injury	31.19	14.05	35	11529	29198	53308304
Hypercapnia	30.81	14.05	17	11547	5010	53332492
Product dose omission issue	30.72	14.05	3	11561	191617	53145885
Immune-mediated pancreatitis	30.34	14.05	6	11558	59	53337443
Joint swelling	30.06	14.05	7	11557	234631	53102871
Rash maculo-papular	27.36	14.05	33	11531	29716	53307786
Congenital central hypoventilation syndrome	27.32	14.05	5	11559	31	53337471
Pneumonia	26.75	14.05	165	11399	407004	52930498
Drug interaction	26.68	14.05	106	11458	219223	53118279
Brain oedema	25.24	14.05	22	11542	13536	53323966
Erysipelas	24.95	14.05	17	11547	7284	53330218
Herpes simplex hepatitis	24.87	14.05	7	11557	337	53337165
Respiratory failure	23.66	14.05	61	11503	100451	53237051
Skin disorder	23.46	14.05	28	11536	24930	53312572
Coma	22.98	14.05	45	11519	61738	53275764
Postresuscitation encephalopathy	22.76	14.05	4	11560	19	53337483
Model for end stage liver disease score increased	22.27	14.05	4	11560	22	53337480
Post procedural haematoma	21.77	14.05	9	11555	1399	53336103
Coagulopathy	21.72	14.05	24	11540	19674	53317828
Tongue exfoliation	21.58	14.05	5	11559	109	53337393
Hepatic failure	21.12	14.05	32	11532	35774	53301728
Sputum increased	20.72	14.05	10	11554	2236	53335266
Brain herniation	19.61	14.05	11	11553	3345	53334157
Pain	19.59	14.05	64	11500	588334	52749168
Face oedema	19.51	14.05	23	11541	20217	53317285
Oliguria	19.26	14.05	16	11548	9222	53328280
Arthralgia	19.03	14.05	42	11522	439741	52897761
Hepatitis fulminant	18.84	14.05	11	11553	3608	53333894
Respiratory tract oedema	18.61	14.05	6	11558	460	53337042
Arthropathy	18.55	14.05	4	11560	141449	53196053
Chronic hepatitis C	18.43	14.05	5	11559	210	53337292
Cataract	18.27	14.05	36	11528	49584	53287918
Respiratory distress	18.23	14.05	29	11535	33798	53303704
Brain death	17.96	14.05	10	11554	2998	53334504
General physical health deterioration	17.83	14.05	71	11493	146871	53190631
Jaundice	17.75	14.05	27	11537	30286	53307216
Systemic lupus erythematosus	17.60	14.05	3	11561	125411	53212091
Contraindicated product administered	17.45	14.05	4	11560	135625	53201877
Urogenital haemorrhage	17.35	14.05	5	11559	262	53337240
Adrenocorticotropic hormone deficiency	17.23	14.05	5	11559	269	53337233
Autoimmune hepatitis	16.50	14.05	14	11550	8304	53329198
Anaphylactic shock	16.50	14.05	22	11542	21871	53315631
Lip pain	16.46	14.05	8	11556	1816	53335686
Delirium	16.41	14.05	31	11533	41398	53296104
Activated partial thromboplastin time prolonged	16.35	14.05	13	11551	7046	53330456
Macroangiopathy	16.17	14.05	4	11560	116	53337386
Decerebrate posture	16.14	14.05	4	11560	117	53337385
Treatment failure	16.10	14.05	4	11560	128399	53209103
Dose calculation error	16.01	14.05	4	11560	121	53337381
Junctional ectopic tachycardia	15.76	14.05	4	11560	129	53337373
Acute respiratory distress syndrome	15.41	14.05	22	11542	23310	53314192
Medication error	15.39	14.05	28	11536	36337	53301165
Flank pain	15.34	14.05	17	11547	13979	53323523
Injection site pain	15.29	14.05	3	11561	113388	53224114
Musculoskeletal stiffness	15.16	14.05	4	11560	123364	53214138
Intentional overdose	15.00	14.05	40	11524	67165	53270337
Acute kidney injury	14.85	14.05	100	11464	253768	53083734
Swelling	14.59	14.05	12	11552	191093	53146409
Pyrexia	14.45	14.05	142	11422	403051	52934451
Soft tissue swelling	14.39	14.05	6	11558	953	53336549
Multiple organ dysfunction syndrome	14.36	14.05	35	11529	55642	53281860

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
Toxic epidermal necrolysis	72.69	12.91	60	11713	20533	32481220
Dyspnoea	57.74	12.91	271	11502	361774	32139979
Pneumonia	57.44	12.91	267	11506	354985	32146768
Congenital hiatus hernia	50.02	12.91	13	11760	271	32501482
General physical health deterioration	45.59	12.91	117	11656	115142	32386611
Stevens-Johnson syndrome	45.16	12.91	44	11729	18665	32483088
Chronic obstructive pulmonary disease	38.79	12.91	66	11707	48687	32453066
Breath sounds abnormal	33.31	12.91	23	11750	6022	32495731
Respiratory failure	28.09	12.91	94	11679	107088	32394665
Productive cough	25.57	12.91	45	11728	34071	32467682
Cell death	25.33	12.91	14	11759	2472	32499281
Product dose omission issue	24.28	12.91	4	11769	102571	32399182
Systemic infection	24.20	12.91	13	11760	2170	32499583
Cyanosis	23.91	12.91	26	11747	12527	32489226
Klebsiella infection	23.48	12.91	21	11752	7991	32493762
Bilirubin conjugated abnormal	23.09	12.91	6	11767	125	32501628
Completed suicide	21.04	12.91	4	11769	92513	32409240
Middle ear inflammation	20.77	12.91	3	11770	0	32501753
Bronchiectasis	19.85	12.91	18	11755	6974	32494779
Wrong dose	19.28	12.91	7	11766	457	32501296
Cough	19.16	12.91	100	11673	138717	32363036
Malignant melanoma in situ	18.69	12.91	9	11764	1194	32500559
Oral herpes	18.54	12.91	15	11758	4982	32496771
Medication error	17.24	12.91	30	11743	22505	32479248
Death	17.06	12.91	76	11697	382441	32119312
Acute respiratory failure	16.69	12.91	34	11739	28694	32473059
Deafness bilateral	16.39	12.91	8	11765	1094	32500659
Bronchospasm	16.33	12.91	20	11753	10935	32490818
Product prescribing error	16.07	12.91	27	11746	19690	32482063
Nikolsky's sign	15.50	12.91	5	11768	228	32501525
Multiple organ dysfunction syndrome	15.47	12.91	58	11715	69796	32431957
Drug abuse	15.28	12.91	5	11768	80238	32421515
Kidney rupture	15.09	12.91	5	11768	248	32501505
Acidosis	14.89	12.91	19	11754	10827	32490926
Graft loss	14.74	12.91	7	11766	901	32500852
Pyrexia	14.46	12.91	178	11595	319790	32181963
Skin odour abnormal	14.31	12.91	7	11766	961	32500792
Acute hepatic failure	13.69	12.91	20	11753	12949	32488804
Septic shock	13.43	12.91	55	11718	68934	32432819
Full blood count abnormal	13.37	12.91	10	11763	2963	32498790
Intestinal prolapse	13.36	12.91	4	11769	142	32501611
Skin haemorrhage	13.35	12.91	11	11762	3748	32498005
Anaphylactoid reaction	13.23	12.91	9	11764	2299	32499454
Empyema	13.20	12.91	10	11763	3021	32498732

Pharmacologic Action:

Source	Code	Description
ATC	R05CB01	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS Mucolytics
ATC	S01XA08	SENSORY ORGANS OPHTHALMOLOGICALS OTHER OPHTHALMOLOGICALS Other ophthalmologicals
ATC	V03AB23	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes
FDA PE	N0000008867	Decreased Respiratory Secretion Viscosity
FDA EPC	N0000175429	Antidote
FDA MoA	N0000175547	Reduction Activity
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000975	Antioxidants
MeSH PA	D000998	Antiviral Agents
MeSH PA	D005100	Expectorants
MeSH PA	D016166	Free Radical Scavengers
MeSH PA	D019141	Respiratory System Agents
FDA EPC	N0000175776	Mucolytic
FDA PE	N0000175960	Increased Glutathione Concentration
FDA EPC	N0000175961	Antidote for Acetaminophen Overdose
CHEBI has role	CHEBI:22586	antioxidants
CHEBI has role	CHEBI:35441	anti-infective drugs
CHEBI has role	CHEBI:36044	anti-virus drug
CHEBI has role	CHEBI:48578	free-radical scavenger
CHEBI has role	CHEBI:73336	vulneraries
CHEBI has role	CHEBI:74529	Tylenol poisoning antidotes
CHEBI has role	CHEBI:77034	mucolytics
CHEBI has role	CHEBI:77746	H. sapiens metabolites
CHEBI has role	CHEBI:173084	ferroptosis inhibitors
CHEBI has role	CHEBI:176497	anti-aging drugs

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Bronchiectasis	indication	12295008	DOID:9563
Amyloidosis	indication	17602002	DOID:9120
Bronchitis	indication	32398004	DOID:6132
General anesthesia	indication	50697003
Poisoning by acetaminophen	indication	70273001
Cystic fibrosis of the lung	indication	86555001
Atelectasis due to Mucous Obstruction	indication
Thick Bronchial Secretions	indication
Contrast Media-Induced Nephrotoxicity Prevention	indication
Meconium ileus	off-label use	206523001
Bronchial Studies	off-label use
Bronchospasm	contraindication	4386001
Peptic ulcer	contraindication	13200003	DOID:750
Esophageal varices	contraindication	28670008
Low blood pressure	contraindication	45007003
Decreased respiratory function	contraindication	80954004
Acute exacerbation of asthma	contraindication	708038006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.22	acidic
pKa2	9.96	acidic
pKa3	12.92	acidic

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
6GM/30ML (200MG/ML)	ACETADOTE	CUMBERLAND PHARMS	N021539	Jan. 23, 2004	RX	INJECTABLE	INTRAVENOUS	8399445	Aug. 24, 2025	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML)	ACETADOTE	CUMBERLAND PHARMS	N021539	Jan. 23, 2004	RX	INJECTABLE	INTRAVENOUS	8653061	Aug. 24, 2025	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
6GM/30ML (200MG/ML)	ACETADOTE	CUMBERLAND PHARMS	N021539	Jan. 23, 2004	RX	INJECTABLE	INTRAVENOUS	9327028	July 21, 2031	COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY
6GM/30ML (200MG/ML)	ACETADOTE	CUMBERLAND PHARMS	N021539	Jan. 23, 2004	RX	INJECTABLE	INTRAVENOUS	8722738	April 6, 2032	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM	CETYLEV	ARBOR PHARMS LLC	N207916	Jan. 29, 2016	DISCN	TABLET, EFFERVESCENT	ORAL	8747894	May 8, 2032	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
2.5GM	CETYLEV	ARBOR PHARMS LLC	N207916	Jan. 29, 2016	DISCN	TABLET, EFFERVESCENT	ORAL	9561204	May 8, 2032	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG	CETYLEV	ARBOR PHARMS LLC	N207916	Jan. 29, 2016	DISCN	TABLET, EFFERVESCENT	ORAL	8747894	May 8, 2032	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
500MG	CETYLEV	ARBOR PHARMS LLC	N207916	Jan. 29, 2016	DISCN	TABLET, EFFERVESCENT	ORAL	9561204	May 8, 2032	METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Bioact source
Cytochrome c	Enzyme	P99999	CYC_HUMAN		WOMBAT-PK
Vascular endothelial growth factor A	Secreted	P15692	VEGFA_HUMAN		WOMBAT-PK
Superoxide dismutase [Mn], mitochondrial	Enzyme	P04179	SODM_HUMAN		WOMBAT-PK
Glutathione synthetase	Enzyme	P48637	GSHB_HUMAN	MODULATOR	DRUGBANK
Cystine/glutamate transporter	Transporter	Q9UPY5	XCT_HUMAN	MODULATOR	SCIENTIFIC LITERATURE

External reference:

ID	Source
4018810	VUID
N0000147113	NUI
D00221	KEGG_DRUG
197	RXNORM
C0001047	UMLSCUI
CHEBI:28939	CHEBI
1ZT	PDB_CHEM_ID
SC2	PDB_CHEM_ID
CHEMBL600	ChEMBL_ID
DB06151	DRUGBANK_ID
D000111	MESH_DESCRIPTOR_UI
12035	PUBCHEM_CID
1535	INN_ID
10945	IUPHAR_LIGAND_ID
WYQ7N0BPYC	UNII
4127	MMSL
48605	MMSL
893	MMSL
d00762	MMSL
000720	NDDF
003524	NDDF
387440002	SNOMEDCT_US
77731008	SNOMEDCT_US
4018810	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3307	SOLUTION	100 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-3308	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0517-7504	INHALANT	100 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0517-7510	INHALANT	100 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0517-7604	INHALANT	200 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0517-7610	INHALANT	200 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0517-7630	INHALANT	200 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	0574-0805	INJECTION	200 mg	INTRAVENOUS	NDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	17478-660	INJECTION	200 mg	INTRAVENOUS	ANDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	25021-812	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	25021-812	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	51754-0104	INJECTION	200 mg	INTRAVENOUS	ANDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5670	SOLUTION	200 mg	ORAL	ANDA	18 sections
Acetylcysteine	Human Prescription Drug Label	1	55150-259	INJECTION, SOLUTION	6 g	INTRAVENOUS	ANDA	22 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5730	INHALANT	100 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	55154-5731	INHALANT	200 mg	RESPIRATORY (INHALATION)	ANDA	18 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-690	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-690	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-691	SOLUTION	100 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-692	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-693	SOLUTION	100 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-694	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-694	SOLUTION	200 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-695	SOLUTION	100 mg	ORAL	ANDA	17 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-963	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	24 sections
Acetylcysteine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-963	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	24 sections
ACETADOTE	HUMAN PRESCRIPTION DRUG LABEL	1	66220-207	INJECTION, SOLUTION	200 mg	INTRAVENOUS	NDA	22 sections
ACETYLCYSTEINE	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1015	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	20 sections
ACETYLCYSTEINE	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1412	INJECTION, SOLUTION	200 mg	INTRAVENOUS	ANDA	1 sections