buprenorphine and naloxone (0378-8768)

Drug Facts

Product Profile

Brand Name buprenorphine and naloxone

Generic Name buprenorphine and naloxone

Labeler mylan pharmaceuticals inc.

Dosage Form FILM

Routes

BUCCAL SUBLINGUAL

Active Ingredients

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

Manufacturer

Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8768

Product ID 0378-8768_008d89ec-5bd7-46d9-bc94-9cdc7405f95d

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207607

DEA Schedule ciii

Listing Expiration 2027-12-31

Marketing Start 2019-02-20

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 03788768

Hyphenated Format 0378-8768

Supplemental Identifiers

RxCUI

1010600 1010604 1307056 1307061

UNII

5Q187997EE 56W8MW3EN1

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 ANDA207607 (source: ndc)

Routes

BUCCAL SUBLINGUAL

source: ndc

Resolved Composition

Strengths

12 mg/1
3 mg/1

source: ndc

Packaging

30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)

source: ndc

Packages (1)

0378-8768-93 30 POUCH in 1 CARTON (0378-8768-93) / 1 FILM in 1 POUCH (0378-8768-16)

Ingredients (2)

buprenorphine hydrochloride (12 mg/1) naloxone hydrochloride dihydrate (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": "008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "openfda": {"unii": ["5Q187997EE", "56W8MW3EN1"], "rxcui": ["1010600", "1010604", "1307056", "1307061"], "spl_set_id": ["557d8d4d-8751-431c-b18e-9d5cf23fc579"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0378-8768-93)  / 1 FILM in 1 POUCH (0378-8768-16)", "package_ndc": "0378-8768-93", "marketing_start_date": "20190220"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0378-8768_008d89ec-5bd7-46d9-bc94-9cdc7405f95d", "dosage_form": "FILM", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0378-8768", "dea_schedule": "CIII", "generic_name": "Buprenorphine and Naloxone", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "12 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE DIHYDRATE", "strength": "3 mg/1"}], "application_number": "ANDA207607", "marketing_category": "ANDA", "marketing_start_date": "20190220", "listing_expiration_date": "20271231"}