acetylcysteine

Generic: acetylcysteine

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler cardinal health 107, llc
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

acetylcysteine 100 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5730
Product ID 55154-5730_91dd7927-d619-479a-821f-a6b233469e1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072489
Listing Expiration 2026-12-31
Marketing Start 2011-05-06

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 551545730
Hyphenated Format 55154-5730

Supplemental Identifiers

RxCUI
307718 307719
UPC
0055154573054 0055154573153
UNII
WYQ7N0BPYC
NUI
N0000175429 N0000175961 N0000008867 N0000175960 N0000175776 N0000175547

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 ANDA072489 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 VIAL, GLASS in 1 BAG (55154-5730-5) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

55154-5730-5 5 VIAL, GLASS in 1 BAG (55154-5730-5) / 4 mL in 1 VIAL, GLASS

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": ["RESPIRATORY (INHALATION)"], "spl_id": "91dd7927-d619-479a-821f-a6b233469e1e", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "upc": ["0055154573054", "0055154573153"], "unii": ["WYQ7N0BPYC"], "rxcui": ["307718", "307719"], "spl_set_id": ["c90fca12-12fb-4cf6-bd6f-83bc0d95df81"], "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": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, GLASS in 1 BAG (55154-5730-5)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "55154-5730-5", "marketing_start_date": "20110506"}], "brand_name": "Acetylcysteine", "product_id": "55154-5730_91dd7927-d619-479a-821f-a6b233469e1e", "dosage_form": "INHALANT", "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": "55154-5730", "generic_name": "Acetylcysteine", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "100 mg/mL"}], "application_number": "ANDA072489", "marketing_category": "ANDA", "marketing_start_date": "20110506", "listing_expiration_date": "20261231"}