buprenorphine

Generic: buprenorphine

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler redpharm drug
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2173
Product ID 67296-2173_44f7016d-6e09-106a-e063-6394a90a648b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201760
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2016-02-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672962173
Hyphenated Format 67296-2173

Supplemental Identifiers

RxCUI
351265
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 ANDA201760 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (67296-2173-3)
source: ndc

Packages (1)

67296-2173-3 30 TABLET in 1 BOTTLE (67296-2173-3)

Ingredients (1)

buprenorphine hydrochloride (8 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": "44f7016d-6e09-106a-e063-6394a90a648b", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351265"], "spl_set_id": ["3dd00186-1f1f-642a-e063-6294a90a6d20"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (67296-2173-3)", "package_ndc": "67296-2173-3", "marketing_start_date": "20160217"}], "brand_name": "Buprenorphine", "product_id": "67296-2173_44f7016d-6e09-106a-e063-6394a90a648b", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "67296-2173", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Redpharm Drug", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA201760", "marketing_category": "ANDA", "marketing_start_date": "20160217", "listing_expiration_date": "20261231"}