pentazocine and naloxone (0591-0395)

Drug Facts

Product Profile

Brand Name pentazocine and naloxone

Generic Name pentazocine hydrochloride and naloxone hydrochloride

Labeler actavis pharma, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0395

Product ID 0591-0395_cd137b2d-e092-4c37-8c12-ea1ac6297451

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA074736

DEA Schedule civ

Listing Expiration 2027-12-31

Marketing Start 1997-05-21

Pharmacologic Class

Classes

competitive opioid antagonists [moa] opioid antagonist [epc] opioid antagonists [moa] partial opioid agonist/antagonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05910395

Hyphenated Format 0591-0395

Supplemental Identifiers

RxCUI

312289

UNII

F850569PQR A36BXO4PPX

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 pentazocine and naloxone (source: ndc)

Generic Name pentazocine hydrochloride and naloxone hydrochloride (source: ndc)

Application Number ANDA074736 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)

source: ndc

Packages (1)

0591-0395-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)

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

{"route": ["ORAL"], "spl_id": "cd137b2d-e092-4c37-8c12-ea1ac6297451", "openfda": {"unii": ["F850569PQR", "A36BXO4PPX"], "rxcui": ["312289"], "spl_set_id": ["a28450a0-ac93-4235-b9a6-58cdf24773cb"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)", "package_ndc": "0591-0395-01", "marketing_start_date": "19970521"}], "brand_name": "Pentazocine and naloxone", "product_id": "0591-0395_cd137b2d-e092-4c37-8c12-ea1ac6297451", "dosage_form": "TABLET", "pharm_class": ["Competitive Opioid Antagonists [MoA]", "Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist/Antagonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0591-0395", "dea_schedule": "CIV", "generic_name": "Pentazocine hydrochloride and naloxone hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pentazocine and naloxone", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".5 mg/1"}, {"name": "PENTAZOCINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA074736", "marketing_category": "ANDA", "marketing_start_date": "19970521", "listing_expiration_date": "20271231"}