naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: heritage pharmaceuticals inc d/b/a avet pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler heritage pharmaceuticals inc d/b/a avet pharmaceuticals inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 23155-886
Product ID 23155-886_6ffda82d-69f6-40f7-90fd-53b628440934
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207905
Listing Expiration 2026-12-31
Marketing Start 2023-10-06

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155886
Hyphenated Format 23155-886

Supplemental Identifiers

RxCUI
1483744
UPC
0323155886030 0323155886016
UNII
Z6375YW9SF

Packaging Origin

Original Packager
true

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 ANDA207905 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (23155-886-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (23155-886-03)
source: ndc

Packages (2)

23155-886-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-886-01) 23155-886-03 30 TABLET, FILM COATED in 1 BOTTLE (23155-886-03)

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": "6ffda82d-69f6-40f7-90fd-53b628440934", "openfda": {"upc": ["0323155886030", "0323155886016"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["c67a22bb-d2bd-4da5-9d3e-6b5281f10891"], "manufacturer_name": ["Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (23155-886-01)", "package_ndc": "23155-886-01", "marketing_start_date": "20231006"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (23155-886-03)", "package_ndc": "23155-886-03", "marketing_start_date": "20231006"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "23155-886_6ffda82d-69f6-40f7-90fd-53b628440934", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "23155-886", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naltrexone Hydrochloride", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA207905", "marketing_category": "ANDA", "marketing_start_date": "20231006", "listing_expiration_date": "20261231"}