buprenorphine

Generic: buprenorphine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7154
Product ID 0904-7154_d28a45db-8ce9-4eef-91ad-2ed508956e59
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078633
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2009-10-08

Pharmacologic Class

Classes
partial opioid agonist [epc] partial opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047154
Hyphenated Format 0904-7154

Supplemental Identifiers

UNII
56W8MW3EN1

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 (source: ndc)
Generic Name buprenorphine (source: ndc)
Application Number ANDA078633 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7154-04) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7154-04 30 BLISTER PACK in 1 CARTON (0904-7154-04) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

buprenorphine hydrochloride (2 mg/1)

Linked Drug Pages (1)

Buprenorphine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "d28a45db-8ce9-4eef-91ad-2ed508956e59", "openfda": {"unii": ["56W8MW3EN1"], "spl_set_id": ["dba586f9-e3f2-4b9c-849b-907c81a5a0ef"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7154-04)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7154-04", "marketing_start_date": "20091008"}], "brand_name": "Buprenorphine", "product_id": "0904-7154_d28a45db-8ce9-4eef-91ad-2ed508956e59", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0904-7154", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA078633", "marketing_category": "ANDA", "marketing_start_date": "20091008", "listing_expiration_date": "20271231"}