naltrexone hydrochloride (71335-0014)

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 71335-0014

Product ID 71335-0014_55b327a1-8549-45f7-8b82-f09a20373e42

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 713350014

Hyphenated Format 71335-0014

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 (71335-0014-1)
90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)
60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)
45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)
120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)
15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)

source: ndc

Packages (6)

71335-0014-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1) 71335-0014-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2) 71335-0014-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3) 71335-0014-4 45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4) 71335-0014-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5) 71335-0014-6 15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)

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": "55b327a1-8549-45f7-8b82-f09a20373e42", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["fa0b0881-97f3-4ca2-bc15-0954293081db"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1)", "package_ndc": "71335-0014-1", "marketing_start_date": "20170808"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2)", "package_ndc": "71335-0014-2", "marketing_start_date": "20170808"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3)", "package_ndc": "71335-0014-3", "marketing_start_date": "20170808"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4)", "package_ndc": "71335-0014-4", "marketing_start_date": "20170808"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5)", "package_ndc": "71335-0014-5", "marketing_start_date": "20170808"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6)", "package_ndc": "71335-0014-6", "marketing_start_date": "20170808"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "71335-0014_55b327a1-8549-45f7-8b82-f09a20373e42", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "71335-0014", "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": "ANDA091205", "marketing_category": "ANDA", "marketing_start_date": "20120118", "listing_expiration_date": "20261231"}