naltrexone hydrochloride

Generic: naltrexone hydrochloride

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

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler accord healthcare, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-081
Product ID 16729-081_424db74c-6c0f-1eb3-e063-6294a90a7db8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091205
Listing Expiration 2026-12-31
Marketing Start 2012-01-18

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729081
Hyphenated Format 16729-081

Supplemental Identifiers

RxCUI
1483744
UNII
Z6375YW9SF

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 naltrexone hydrochloride (source: ndc)
Generic Name naltrexone hydrochloride (source: ndc)
Application Number ANDA091205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)
source: ndc

Packages (2)

16729-081-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01) 16729-081-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)

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": "424db74c-6c0f-1eb3-e063-6294a90a7db8", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["49aa3d6d-2270-4615-aafa-b440859ab870"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)", "package_ndc": "16729-081-01", "marketing_start_date": "20120118"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)", "package_ndc": "16729-081-10", "marketing_start_date": "20120118"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "16729-081_424db74c-6c0f-1eb3-e063-6294a90a7db8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "16729-081", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naltrexone Hydrochloride", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA091205", "marketing_category": "ANDA", "marketing_start_date": "20120118", "listing_expiration_date": "20261231"}