0591-0395

Generic: pentazocine hydrochloride and naloxone hydrochloride

Labeler: actavis pharma, inc.
NDC Directory DRUG FOR FURTHER PROCESSING DRUG FOR FURTHER PROCESSING Active

Drug Facts

Product Profile

Brand Name
Generic Name pentazocine hydrochloride and naloxone hydrochloride
Labeler actavis pharma, inc.
Dosage Form TABLET
Active Ingredients

naloxone hydrochloride .5 mg/1, pentazocine hydrochloride 50 mg/1

Identifiers & Regulatory

Product NDC 0591-0395
Product ID 0591-0395_51abfbe5-cccf-4e8a-8600-19890c3b50fb
Product Type DRUG FOR FURTHER PROCESSING
Marketing Category DRUG FOR FURTHER PROCESSING
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2015-09-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910395
Hyphenated Format 0591-0395

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 pentazocine and naloxone (source: label)
Generic Name pentazocine hydrochloride and naloxone hydrochloride (source: ndc)
Application Number ANDA074736 (source: label)
Routes
oral
source: label

Resolved Composition

Strengths
  • .5 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 45460 TABLET in 1 BOX (0591-0395-00)
  • 54552 TABLET in 1 CONTAINER (0591-0395-77)
source: ndc

Packages (2)

0591-0395-00 45460 TABLET in 1 BOX (0591-0395-00) 0591-0395-77 54552 TABLET in 1 CONTAINER (0591-0395-77)

Ingredients (2)

naloxone hydrochloride (.5 mg/1) pentazocine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Pentazocine and naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "51abfbe5-cccf-4e8a-8600-19890c3b50fb", "openfda": {}, "finished": false, "packaging": [{"description": "45460 TABLET in 1 BOX (0591-0395-00)", "package_ndc": "0591-0395-00", "marketing_start_date": "16-SEP-15"}, {"description": "54552 TABLET in 1 CONTAINER (0591-0395-77)", "package_ndc": "0591-0395-77", "marketing_start_date": "16-SEP-24"}], "product_id": "0591-0395_51abfbe5-cccf-4e8a-8600-19890c3b50fb", "dosage_form": "TABLET", "product_ndc": "0591-0395", "dea_schedule": "CIV", "generic_name": "Pentazocine Hydrochloride and Naloxone Hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "DRUG FOR FURTHER PROCESSING", "brand_name_base": null, "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".5 mg/1"}, {"name": "PENTAZOCINE HYDROCHLORIDE", "strength": "50 mg/1"}], "marketing_category": "DRUG FOR FURTHER PROCESSING", "marketing_start_date": "20150916", "listing_expiration_date": "20261231"}