naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6820
Product ID 50090-6820_074fe42c-ca67-4dda-8bc8-30a6c2cd1c4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076264
Listing Expiration 2026-12-31
Marketing Start 2002-03-22

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906820
Hyphenated Format 50090-6820

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 ANDA076264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-6820-0)
source: ndc

Packages (1)

50090-6820-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-6820-0)

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": "074fe42c-ca67-4dda-8bc8-30a6c2cd1c4f", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["0103a32b-14a9-48a8-8952-b2b12ef09649"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-6820-0)", "package_ndc": "50090-6820-0", "marketing_start_date": "20231114"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "50090-6820_074fe42c-ca67-4dda-8bc8-30a6c2cd1c4f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "50090-6820", "generic_name": "naltrexone hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALTREXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076264", "marketing_category": "ANDA", "marketing_start_date": "20020322", "listing_expiration_date": "20261231"}