acetylcysteine

Generic: acetylcysteine

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

Drug Facts

Product Profile

Brand Name acetylcysteine
Generic Name acetylcysteine
Labeler american regent, inc.
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

acetylcysteine 200 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-7604
Product ID 0517-7604_2bcb9dd3-17f8-439e-a395-aa081c5cc4bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072547
Listing Expiration 2026-12-31
Marketing Start 1995-10-01

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 05177604
Hyphenated Format 0517-7604

Supplemental Identifiers

RxCUI
307718 307719
UPC
0305177510032 0305177604250 0305177504253 0305177610039
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 ANDA072547 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0517-7604-25 25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASS

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": ["RESPIRATORY (INHALATION)"], "spl_id": "2bcb9dd3-17f8-439e-a395-aa081c5cc4bf", "openfda": {"nui": ["N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547"], "upc": ["0305177510032", "0305177604250", "0305177504253", "0305177610039"], "unii": ["WYQ7N0BPYC"], "rxcui": ["307718", "307719"], "spl_set_id": ["f56b4087-db48-4fd7-84ec-9c927962b805"], "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": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 TRAY (0517-7604-25)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "0517-7604-25", "marketing_start_date": "19951001"}], "brand_name": "Acetylcysteine", "product_id": "0517-7604_2bcb9dd3-17f8-439e-a395-aa081c5cc4bf", "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": "0517-7604", "generic_name": "acetylcysteine", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Acetylcysteine", "active_ingredients": [{"name": "ACETYLCYSTEINE", "strength": "200 mg/mL"}], "application_number": "ANDA072547", "marketing_category": "ANDA", "marketing_start_date": "19951001", "listing_expiration_date": "20261231"}