naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: nucare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naltrexone hydrochloride 50 mg/1

Manufacturer
NuCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68071-3654
Product ID 68071-3654_2a2ff668-e2bb-5308-e063-6294a90a832d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075274
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713654
Hyphenated Format 68071-3654

Supplemental Identifiers

RxCUI
1483744
UPC
0368071365436
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 (68071-3654-3)
source: ndc

Packages (1)

68071-3654-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3654-3)

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": "2a2ff668-e2bb-5308-e063-6294a90a832d", "openfda": {"upc": ["0368071365436"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["1e059495-5e64-0cb0-e063-6394a90a3ffc"], "manufacturer_name": ["NuCare Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3654-3)", "package_ndc": "68071-3654-3", "marketing_start_date": "20240724"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "68071-3654_2a2ff668-e2bb-5308-e063-6294a90a832d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "68071-3654", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "NuCare Pharmaceuticals Inc.", "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_start_date": "20240215", "listing_expiration_date": "20261231"}