acetylcysteine

Generic: acetylcysteine

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler hospira, inc.
Dosage Form SOLUTION
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

acetylcysteine 100 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-3307
Product ID 0409-3307_42b68a86-b5df-4dc1-9781-e9ef6c2e56bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073664
Listing Expiration 2026-12-31
Marketing Start 2005-04-30

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 04093307
Hyphenated Format 0409-3307

Supplemental Identifiers

RxCUI
307718 307719
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 ANDA073664 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)
source: ndc

Packages (1)

0409-3307-03 3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)

Ingredients (1)

acetylcysteine (100 mg/mL)

Linked Drug Pages (1)

Acetylcysteine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "42b68a86-b5df-4dc1-9781-e9ef6c2e56bc", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "unii": ["WYQ7N0BPYC"], "rxcui": ["307718", "307719"], "spl_set_id": ["5558a5f5-e821-473b-7d8a-5d33d09f0586"], "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": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL in 1 CARTON (0409-3307-03)  / 30 mL in 1 VIAL (0409-3307-11)", "package_ndc": "0409-3307-03", "marketing_start_date": "20050430"}], "brand_name": "Acetylcysteine", "product_id": "0409-3307_42b68a86-b5df-4dc1-9781-e9ef6c2e56bc", "dosage_form": "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": "0409-3307", "generic_name": "ACETYLCYSTEINE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "100 mg/mL"}], "application_number": "ANDA073664", "marketing_category": "ANDA", "marketing_start_date": "20050430", "listing_expiration_date": "20261231"}