pentazocine and naloxone (63304-506)

Drug Facts

Product Profile

Brand Name pentazocine and naloxone

Generic Name pentazocine and naloxone

Labeler sun pharmaceutical industries, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-506

Product ID 63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA075523

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2018-07-31

Pharmacologic Class

Established (EPC)

partial opioid agonist/antagonist [epc]

Mechanism of Action

competitive opioid antagonists [moa] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304506

Hyphenated Format 63304-506

Supplemental Identifiers

RxCUI

312289

UPC

0363304506013

UNII

F850569PQR RP4A60D26L

NUI

N0000175686 N0000175688 N0000175685

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 and naloxone (source: ndc)

Application Number ANDA075523 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.5 mg/1
50 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (63304-506-01)

source: ndc

Packages (1)

63304-506-01 100 TABLET in 1 BOTTLE (63304-506-01)

Ingredients (2)

naloxone hydrochloride (.5 mg/1) pentazocine (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": "48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3", "openfda": {"nui": ["N0000175686", "N0000175688", "N0000175685"], "upc": ["0363304506013"], "unii": ["F850569PQR", "RP4A60D26L"], "rxcui": ["312289"], "spl_set_id": ["41ebdaaf-3bbc-419f-b996-0341efc14623"], "pharm_class_epc": ["Partial Opioid Agonist/Antagonist [EPC]"], "pharm_class_moa": ["Competitive Opioid Antagonists [MoA]", "Partial Opioid Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63304-506-01)", "package_ndc": "63304-506-01", "marketing_start_date": "20180731"}], "brand_name": "pentazocine and naloxone", "product_id": "63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3", "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": "63304-506", "dea_schedule": "CIV", "generic_name": "pentazocine and naloxone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "pentazocine and naloxone", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".5 mg/1"}, {"name": "PENTAZOCINE", "strength": "50 mg/1"}], "application_number": "ANDA075523", "marketing_category": "ANDA", "marketing_start_date": "20180731", "listing_expiration_date": "20261231"}