naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-964
Product ID 71610-964_43cd684b-f17f-80ab-e063-6294a90a6f5a
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 71610964
Hyphenated Format 71610-964

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
  • 600 TABLET, FILM COATED in 1 BOTTLE (71610-964-31)
source: ndc

Packages (1)

71610-964-31 600 TABLET, FILM COATED in 1 BOTTLE (71610-964-31)

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": "43cd684b-f17f-80ab-e063-6294a90a6f5a", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["43cd6961-4793-85ee-e063-6294a90ad772"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "600 TABLET, FILM COATED in 1 BOTTLE (71610-964-31)", "package_ndc": "71610-964-31", "marketing_start_date": "20251113"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "71610-964_43cd684b-f17f-80ab-e063-6294a90a6f5a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "71610-964", "generic_name": "naltrexone hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "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"}