buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler advagen pharma ltd
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 8 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-183
Product ID 72888-183_47a1af00-e74e-d1cc-e063-6394a90ab889
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090279
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2015-06-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888183
Hyphenated Format 72888-183

Supplemental Identifiers

RxCUI
351264 351265
UPC
0372888183909 0372888182308 0372888183305 0372888182902
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 hydrochloride (source: ndc)
Generic Name buprenorphine hydrochloride (source: ndc)
Application Number ANDA090279 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (72888-183-30)
  • 90 TABLET in 1 BOTTLE (72888-183-90)
source: ndc

Packages (2)

72888-183-30 30 TABLET in 1 BOTTLE (72888-183-30) 72888-183-90 90 TABLET in 1 BOTTLE (72888-183-90)

Ingredients (1)

buprenorphine hydrochloride (8 mg/1)

Linked Drug Pages (1)

buprenorphine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "47a1af00-e74e-d1cc-e063-6394a90ab889", "openfda": {"upc": ["0372888183909", "0372888182308", "0372888183305", "0372888182902"], "unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["699638dd-3a53-445f-a545-d0e6eabfe1c9"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-183-30)", "package_ndc": "72888-183-30", "marketing_start_date": "20240123"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72888-183-90)", "package_ndc": "72888-183-90", "marketing_start_date": "20240123"}], "brand_name": "buprenorphine hydrochloride", "product_id": "72888-183_47a1af00-e74e-d1cc-e063-6394a90ab889", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "72888-183", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA090279", "marketing_category": "ANDA", "marketing_start_date": "20150610", "listing_expiration_date": "20271231"}