buprenorphine and naloxone (3215-6523)

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone

Generic Name buprenorphine and naloxone

Labeler aveva drug delivery systems inc.

Dosage Form FILM

Routes

BUCCAL SUBLINGUAL

Active Ingredients

buprenorphine hydrochloride 8 mg/1, naloxone hydrochloride 2 mg/1

Manufacturer

Aveva Drug Delivery Systems Inc.

Identifiers & Regulatory

Product NDC 3215-6523

Product ID 3215-6523_3afe7278-3008-3b01-e063-6294a90a88bf

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 32156523

Hyphenated Format 3215-6523

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

8 mg/1
2 mg/1

source: ndc

Packaging

30 POUCH in 1 CARTON (3215-6523-30) / 1 FILM in 1 POUCH (3215-6523-01)

source: ndc

Packages (1)

3215-6523-30 30 POUCH in 1 CARTON (3215-6523-30) / 1 FILM in 1 POUCH (3215-6523-01)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride (2 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": "3afe7278-3008-3b01-e063-6294a90a88bf", "openfda": {"unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["cb112448-49a1-4209-bcdb-7cfae6501f51"], "manufacturer_name": ["Aveva Drug Delivery Systems Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (3215-6523-30)  / 1 FILM in 1 POUCH (3215-6523-01)", "package_ndc": "3215-6523-30", "marketing_start_date": "20230829"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "3215-6523_3afe7278-3008-3b01-e063-6294a90a88bf", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "3215-6523", "dea_schedule": "CIII", "generic_name": "buprenorphine and naloxone", "labeler_name": "Aveva Drug Delivery Systems Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA212756", "marketing_category": "ANDA", "marketing_start_date": "20230829", "listing_expiration_date": "20261231"}