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 68094-909
Product ID 68094-909_efc0724d-4c6e-4974-928c-fd50774f5980
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075274
Marketing Start 2024-02-15
Marketing End 2028-06-30

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094909
Hyphenated Format 68094-909

Supplemental Identifiers

RxCUI
1483744
UPC
0368094909501
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (68094-909-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (68094-909-50)
source: ndc

Packages (2)

68094-909-30 30 TABLET, FILM COATED in 1 BOTTLE (68094-909-30) 68094-909-50 100 TABLET, FILM COATED in 1 BOTTLE (68094-909-50)

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": "efc0724d-4c6e-4974-928c-fd50774f5980", "openfda": {"upc": ["0368094909501"], "unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["b09b4b5e-795a-48e7-b7cc-2e29f41c5660"], "manufacturer_name": ["Precision Dose Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68094-909-30)", "package_ndc": "68094-909-30", "marketing_end_date": "20280630", "marketing_start_date": "20240215"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68094-909-50)", "package_ndc": "68094-909-50", "marketing_end_date": "20280630", "marketing_start_date": "20240215"}], "brand_name": "Naltrexone Hydrochloride", "product_id": "68094-909_efc0724d-4c6e-4974-928c-fd50774f5980", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "68094-909", "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_end_date": "20280630", "marketing_start_date": "20240215"}