naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-632
Product ID 42291-632_4a197f32-b382-2a52-e063-6394a90ad197
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075274
Marketing Start 2015-03-26
Marketing End 2028-06-30

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291632
Hyphenated Format 42291-632

Supplemental Identifiers

RxCUI
1483744
UNII
Z6375YW9SF

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 naltrexone hydrochloride (source: ndc)
Generic Name naltrexone hydrochloride (source: ndc)
Application Number ANDA075274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60)
source: ndc

Packages (2)

42291-632-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30) 42291-632-60 60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60)

Ingredients (1)

naltrexone hydrochloride (50 mg/1)

Linked Drug Pages (1)

Naltrexone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a197f32-b382-2a52-e063-6394a90ad197", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["21b43dab-015c-c82f-ba6e-27da0ec12fc5"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)", "package_ndc": "42291-632-30", "marketing_end_date": "20280630", "marketing_start_date": "20150326"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60)", "package_ndc": "42291-632-60", "marketing_end_date": "20280630", "marketing_start_date": "20250724"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "42291-632_4a197f32-b382-2a52-e063-6394a90ad197", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "42291-632", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naltrexone Hydrochloride", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075274", "marketing_category": "ANDA", "marketing_end_date": "20280630", "marketing_start_date": "20150326"}