buprenorphine and naloxone (50742-365)

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone

Generic Name buprenorphine and naloxone

Labeler ingenus pharmaceuticals, llc

Dosage Form FILM

Routes

BUCCAL SUBLINGUAL

Active Ingredients

buprenorphine hydrochloride 12 mg/1, naloxone hydrochloride 3 mg/1

Manufacturer

INGENUS PHARMACEUTICALS, LLC

Identifiers & Regulatory

Product NDC 50742-365

Product ID 50742-365_3f655839-d97b-89d9-e063-6394a90a515a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212756

DEA Schedule ciii

Listing Expiration 2026-12-31

Marketing Start 2023-08-29

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742365

Hyphenated Format 50742-365

Supplemental Identifiers

RxCUI

1010600 1010604 1307056 1307061

UNII

56W8MW3EN1 F850569PQR

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 buprenorphine and naloxone (source: ndc)

Generic Name buprenorphine and naloxone (source: ndc)

Application Number ANDA212756 (source: ndc)

Routes

BUCCAL SUBLINGUAL

source: ndc

Resolved Composition

Strengths

12 mg/1
3 mg/1

source: ndc

Packaging

30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01)

source: ndc

Packages (1)

50742-365-30 30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01)

Ingredients (2)

buprenorphine hydrochloride (12 mg/1) naloxone hydrochloride (3 mg/1)

Linked Drug Pages (1)

Buprenorphine and Naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["BUCCAL", "SUBLINGUAL"], "spl_id": "3f655839-d97b-89d9-e063-6394a90a515a", "openfda": {"unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["4951ec29-609b-4836-b0e4-0d9c1d6ae6fe"], "manufacturer_name": ["INGENUS PHARMACEUTICALS, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (50742-365-30)  / 1 FILM in 1 POUCH (50742-365-01)", "package_ndc": "50742-365-30", "marketing_start_date": "20230829"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "50742-365_3f655839-d97b-89d9-e063-6394a90a515a", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "50742-365", "dea_schedule": "CIII", "generic_name": "buprenorphine and naloxone", "labeler_name": "INGENUS PHARMACEUTICALS, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "12 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": "3 mg/1"}], "application_number": "ANDA212756", "marketing_category": "ANDA", "marketing_start_date": "20230829", "listing_expiration_date": "20261231"}