naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-199
Product ID 82804-199_f3305f0b-fb9e-4009-b28f-47fe9b1b618b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090356
Listing Expiration 2026-12-31
Marketing Start 2012-02-29

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804199
Hyphenated Format 82804-199

Supplemental Identifiers

RxCUI
1483744
UPC
0382804199303
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 ANDA090356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (82804-199-30)
source: ndc

Packages (1)

82804-199-30 30 TABLET, FILM COATED in 1 BOTTLE (82804-199-30)

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": "f3305f0b-fb9e-4009-b28f-47fe9b1b618b", "openfda": {"upc": ["0382804199303"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["f3305f0b-fb9e-4009-b28f-47fe9b1b618b"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (82804-199-30)", "package_ndc": "82804-199-30", "marketing_start_date": "20250221"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "82804-199_f3305f0b-fb9e-4009-b28f-47fe9b1b618b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "82804-199", "generic_name": "NALTREXONE HYDROCHLORIDE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALTREXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA090356", "marketing_category": "ANDA", "marketing_start_date": "20120229", "listing_expiration_date": "20261231"}