naltrexone hydrochloride (71335-1480)

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride

Generic Name naltrexone hydrochloride

Labeler bryant ranch prepack

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer

Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1480

Product ID 71335-1480_63da50ae-3486-4314-bbfd-dd0ba473bfdc

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 713351480

Hyphenated Format 71335-1480

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 (71335-1480-1)
90 TABLET, FILM COATED in 1 BOTTLE (71335-1480-2)
60 TABLET, FILM COATED in 1 BOTTLE (71335-1480-3)
45 TABLET, FILM COATED in 1 BOTTLE (71335-1480-4)
120 TABLET, FILM COATED in 1 BOTTLE (71335-1480-5)
15 TABLET, FILM COATED in 1 BOTTLE (71335-1480-6)

source: ndc

Packages (6)

71335-1480-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-1480-1) 71335-1480-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-1480-2) 71335-1480-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-1480-3) 71335-1480-4 45 TABLET, FILM COATED in 1 BOTTLE (71335-1480-4) 71335-1480-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-1480-5) 71335-1480-6 15 TABLET, FILM COATED in 1 BOTTLE (71335-1480-6)

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": "63da50ae-3486-4314-bbfd-dd0ba473bfdc", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["838a1e88-1179-4a2a-a737-8ce008bb96a7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-1480-1)", "package_ndc": "71335-1480-1", "marketing_start_date": "20200116"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1480-2)", "package_ndc": "71335-1480-2", "marketing_start_date": "20200122"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-1480-3)", "package_ndc": "71335-1480-3", "marketing_start_date": "20240530"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71335-1480-4)", "package_ndc": "71335-1480-4", "marketing_start_date": "20240530"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-1480-5)", "package_ndc": "71335-1480-5", "marketing_start_date": "20240530"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-1480-6)", "package_ndc": "71335-1480-6", "marketing_start_date": "20200910"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "71335-1480_63da50ae-3486-4314-bbfd-dd0ba473bfdc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "71335-1480", "generic_name": "naltrexone hydrochloride", "labeler_name": "Bryant Ranch Prepack", "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"}