acetylcysteine

Generic: acetylcysteine

Labeler: onesource specialty pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler onesource specialty pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
ONESOURCE SPECIALTY PHARMA LIMITED

Identifiers & Regulatory

Product NDC 83270-001
Product ID 83270-001_3e98253c-4b61-85a5-e063-6394a90ab80c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217182
Listing Expiration 2026-12-31
Marketing Start 2023-04-26

Pharmacologic Class

Established (EPC)
antidote [epc] antidote for acetaminophen overdose [epc] mucolytic [epc]
Mechanism of Action
reduction activity [moa]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased glutathione concentration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83270001
Hyphenated Format 83270-001

Supplemental Identifiers

RxCUI
465377
UNII
WYQ7N0BPYC
NUI
N0000175429 N0000175961 N0000008867 N0000175960 N0000175776 N0000175547

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name acetylcysteine (source: ndc)
Generic Name acetylcysteine (source: ndc)
Application Number ANDA217182 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01)
source: ndc

Packages (1)

83270-001-04 4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04) / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01)

Ingredients (1)

acetylcysteine (200 mg/mL)

Linked Drug Pages (1)

Acetylcysteine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3e98253c-4b61-85a5-e063-6394a90ab80c", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377"], "spl_set_id": ["3b0310d2-4e70-4b94-8d69-cb5999a32b54"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Glutathione Concentration [PE]"], "pharm_class_epc": ["Antidote [EPC]", "Antidote for Acetaminophen Overdose [EPC]", "Mucolytic [EPC]"], "pharm_class_moa": ["Reduction Activity [MoA]"], "manufacturer_name": ["ONESOURCE SPECIALTY PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (83270-001-04)  / 30 mL in 1 VIAL, SINGLE-DOSE (83270-001-01)", "package_ndc": "83270-001-04", "marketing_start_date": "20230426"}], "brand_name": "Acetylcysteine", "product_id": "83270-001_3e98253c-4b61-85a5-e063-6394a90ab80c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antidote [EPC]", "Antidote for Acetaminophen Overdose [EPC]", "Decreased Respiratory Secretion Viscosity [PE]", "Increased Glutathione Concentration [PE]", "Mucolytic [EPC]", "Reduction Activity [MoA]"], "product_ndc": "83270-001", "generic_name": "Acetylcysteine", "labeler_name": "ONESOURCE SPECIALTY PHARMA LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "ANDA217182", "marketing_category": "ANDA", "marketing_start_date": "20230426", "listing_expiration_date": "20261231"}