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 50090-4925
Product ID 50090-4925_4242e317-1764-436a-aff6-338a58f1b0a2
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 500904925
Hyphenated Format 50090-4925

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 ANDA091205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0)
source: ndc

Packages (1)

50090-4925-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0)

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": "4242e317-1764-436a-aff6-338a58f1b0a2", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["00c04ff4-b6f2-466c-9ab9-813a60577db0"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0)", "package_ndc": "50090-4925-0", "marketing_start_date": "20200220"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "50090-4925_4242e317-1764-436a-aff6-338a58f1b0a2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "50090-4925", "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": "ANDA091205", "marketing_category": "ANDA", "marketing_start_date": "20120118", "listing_expiration_date": "20261231"}