acetylcysteine

Generic: acetylcysteine

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler indoco remedies limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-412
Product ID 14445-412_2b8da336-9b90-466e-9ac2-6f6cbb999f9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215620
Listing Expiration 2026-12-31
Marketing Start 2022-03-01

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 14445412
Hyphenated Format 14445-412

Supplemental Identifiers

RxCUI
465377
UPC
0314445412305
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 ANDA215620 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 4 VIAL in 1 CARTON (14445-412-04) / 30 mL in 1 VIAL (14445-412-30)
source: ndc

Packages (1)

14445-412-04 4 VIAL in 1 CARTON (14445-412-04) / 30 mL in 1 VIAL (14445-412-30)

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": "2b8da336-9b90-466e-9ac2-6f6cbb999f9f", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "upc": ["0314445412305"], "unii": ["WYQ7N0BPYC"], "rxcui": ["465377"], "spl_set_id": ["6588c28d-0515-4cdf-99d3-c4ad3fd0976c"], "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": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL in 1 CARTON (14445-412-04)  / 30 mL in 1 VIAL (14445-412-30)", "package_ndc": "14445-412-04", "marketing_start_date": "20220301"}], "brand_name": "ACETYLCYSTEINE", "product_id": "14445-412_2b8da336-9b90-466e-9ac2-6f6cbb999f9f", "dosage_form": "INJECTION", "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": "14445-412", "generic_name": "ACETYLCYSTEINE", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ACETYLCYSTEINE", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "ANDA215620", "marketing_category": "ANDA", "marketing_start_date": "20220301", "listing_expiration_date": "20261231"}