buprenorphine

Generic: buprenorphine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-9475
Product ID 63629-9475_0528c316-c40e-4d8e-bb5e-2663faf8a307
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207276
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2017-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636299475
Hyphenated Format 63629-9475

Supplemental Identifiers

RxCUI
351264
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 ANDA207276 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63629-9475-1)
source: ndc

Packages (1)

63629-9475-1 30 TABLET in 1 BOTTLE (63629-9475-1)

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": "0528c316-c40e-4d8e-bb5e-2663faf8a307", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264"], "spl_set_id": ["bc5a7137-9e8f-438e-84d9-bdbf1db12998"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-9475-1)", "package_ndc": "63629-9475-1", "marketing_start_date": "20221128"}], "brand_name": "BUPRENORPHINE", "product_id": "63629-9475_0528c316-c40e-4d8e-bb5e-2663faf8a307", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "63629-9475", "dea_schedule": "CIII", "generic_name": "BUPRENORPHINE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUPRENORPHINE", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA207276", "marketing_category": "ANDA", "marketing_start_date": "20171025", "listing_expiration_date": "20261231"}