pentazocine hydrochloride and naloxone hydrochloride

Generic: pentazocine hydrochloride and naloxone hydrochloride

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentazocine hydrochloride and naloxone hydrochloride
Generic Name pentazocine hydrochloride and naloxone hydrochloride
Labeler lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-680
Product ID 43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075735
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-05-11

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 43386680
Hyphenated Format 43386-680

Supplemental Identifiers

RxCUI
312289
UPC
0343386680016
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 hydrochloride and naloxone hydrochloride (source: ndc)
Generic Name pentazocine hydrochloride and naloxone hydrochloride (source: ndc)
Application Number ANDA075735 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-680-01)
source: ndc

Packages (1)

43386-680-01 100 TABLET in 1 BOTTLE (43386-680-01)

Ingredients (2)

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

Linked Drug Pages (1)

PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21e7776e-65d0-45fb-a1b2-13f49055ad64", "openfda": {"upc": ["0343386680016"], "unii": ["F850569PQR", "A36BXO4PPX"], "rxcui": ["312289"], "spl_set_id": ["017ef042-40aa-44c9-baa8-037f06356845"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "100 TABLET in 1 BOTTLE (43386-680-01)", "package_ndc": "43386-680-01", "marketing_start_date": "20110511"}], "brand_name": "PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE", "product_id": "43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64", "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": "43386-680", "dea_schedule": "CIV", "generic_name": "pentazocine hydrochloride and naloxone hydrochloride", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALOXONE HYDROCHLORIDE", "strength": ".5 mg/1"}, {"name": "PENTAZOCINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA075735", "marketing_category": "ANDA", "marketing_start_date": "20110511", "listing_expiration_date": "20261231"}