naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: precision dose inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

naltrexone hydrochloride 50 mg/1

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-853
Product ID 68094-853_7670a1a9-f14e-4e9e-8b3e-f8d5e52125e0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075274
Listing Expiration 2026-12-31
Marketing Start 2014-10-29

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094853
Hyphenated Format 68094-853

Supplemental Identifiers

RxCUI
1483744
UPC
0368094853620
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 ANDA075274 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (68094-853-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)
  • 3 BLISTER PACK in 1 CARTON (68094-853-62) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)
  • 2 BLISTER PACK in 1 CARTON (68094-853-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)
source: ndc

Packages (3)

68094-853-61 10 BLISTER PACK in 1 CARTON (68094-853-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) 68094-853-62 3 BLISTER PACK in 1 CARTON (68094-853-62) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) 68094-853-66 2 BLISTER PACK in 1 CARTON (68094-853-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)

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": "7670a1a9-f14e-4e9e-8b3e-f8d5e52125e0", "openfda": {"upc": ["0368094853620"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["74087d2f-468d-4de1-a2fc-a489d0f2abef"], "manufacturer_name": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68094-853-61)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)", "package_ndc": "68094-853-61", "marketing_start_date": "20240815"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68094-853-62)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)", "package_ndc": "68094-853-62", "marketing_end_date": "20261231", "marketing_start_date": "20141029"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (68094-853-66)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59)", "package_ndc": "68094-853-66", "marketing_start_date": "20240815"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "68094-853_7670a1a9-f14e-4e9e-8b3e-f8d5e52125e0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "68094-853", "generic_name": "naltrexone Hydrochloride", "labeler_name": "Precision Dose 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": "20141029", "listing_expiration_date": "20261231"}