naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler elite laboratories, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-300
Product ID 64850-300_cae1ac14-ab22-42d1-8449-5e36c137b905
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075274
Listing Expiration 2026-12-31
Marketing Start 2025-08-15

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850300
Hyphenated Format 64850-300

Supplemental Identifiers

RxCUI
1483744
UPC
0364850300018 0364850300308
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 ANDA075274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (64850-300-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30)
source: ndc

Packages (2)

64850-300-01 100 TABLET, FILM COATED in 1 BOTTLE (64850-300-01) 64850-300-30 30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30)

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": "cae1ac14-ab22-42d1-8449-5e36c137b905", "openfda": {"upc": ["0364850300018", "0364850300308"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["5f188bdc-2009-43aa-ad32-f06dbfac2642"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (64850-300-01)", "package_ndc": "64850-300-01", "marketing_start_date": "20250815"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30)", "package_ndc": "64850-300-30", "marketing_start_date": "20250815"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "64850-300_cae1ac14-ab22-42d1-8449-5e36c137b905", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "64850-300", "generic_name": "Naltrexone Hydrochloride", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naltrexone Hydrochloride", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075274", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}