buprenorphine

Generic: buprenorphine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

buprenorphine hydrochloride 8 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-129
Product ID 50268-129_47e239f0-069e-a3e1-e063-6294a90a7bf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201760
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2024-03-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268129
Hyphenated Format 50268-129

Supplemental Identifiers

RxCUI
351264 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
  • 50 BLISTER PACK in 1 BOX (50268-129-15) / 1 TABLET in 1 BLISTER PACK (50268-129-11)
source: ndc

Packages (1)

50268-129-15 50 BLISTER PACK in 1 BOX (50268-129-15) / 1 TABLET in 1 BLISTER PACK (50268-129-11)

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": "47e239f0-069e-a3e1-e063-6294a90a7bf1", "openfda": {"unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["1408cd8f-a0b5-6be7-e063-6394a90a0b41"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-129-15)  / 1 TABLET in 1 BLISTER PACK (50268-129-11)", "package_ndc": "50268-129-15", "marketing_start_date": "20240319"}], "brand_name": "Buprenorphine", "product_id": "50268-129_47e239f0-069e-a3e1-e063-6294a90a7bf1", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "50268-129", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "AvPAK", "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": "20240319", "listing_expiration_date": "20271231"}