buprenorphine

Generic: buprenorphine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine
Generic Name buprenorphine
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0176
Product ID 0054-0176_9c6bccc7-562f-4dc1-9076-b482570bee70
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 00540176
Hyphenated Format 0054-0176

Supplemental Identifiers

RxCUI
351264 351265
UPC
0300540176136
UNII
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 (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 TABLET in 1 BOTTLE (0054-0176-13)
source: ndc

Packages (1)

0054-0176-13 30 TABLET in 1 BOTTLE (0054-0176-13)

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": "9c6bccc7-562f-4dc1-9076-b482570bee70", "openfda": {"upc": ["0300540176136"], "unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["1bf8b35a-b769-465c-a2f8-099868dfcd2f"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-0176-13)", "package_ndc": "0054-0176-13", "marketing_start_date": "20091008"}], "brand_name": "Buprenorphine", "product_id": "0054-0176_9c6bccc7-562f-4dc1-9076-b482570bee70", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0054-0176", "dea_schedule": "CIII", "generic_name": "Buprenorphine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "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"}