acetylcysteine

Generic: acetylcysteine

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler glenmark pharmaceuticals inc., usa
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-946
Product ID 68462-946_e9303a1d-f362-42de-a790-9017a70dcaad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213693
Listing Expiration 2026-12-31
Marketing Start 2024-09-25

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 68462946
Hyphenated Format 68462-946

Supplemental Identifiers

RxCUI
465377
UPC
0368462946305 0368462946121
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 ANDA213693 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12) / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30)
source: ndc

Packages (1)

68462-946-12 4 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12) / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30)

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": "e9303a1d-f362-42de-a790-9017a70dcaad", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "upc": ["0368462946305", "0368462946121"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377"], "spl_set_id": ["f811ddfc-d7c1-4637-ae81-80c38a77cb80"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12)  / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30)", "package_ndc": "68462-946-12", "marketing_start_date": "20240925"}], "brand_name": "Acetylcysteine", "product_id": "68462-946_e9303a1d-f362-42de-a790-9017a70dcaad", "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": "68462-946", "generic_name": "Acetylcysteine", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "ANDA213693", "marketing_category": "ANDA", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}