buprenorphine hydrochloride

Generic: buprenorphine hydrochloride

Labeler: pai holdings, llc dba pharmaceutical associates, inc. and dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name buprenorphine hydrochloride
Generic Name buprenorphine hydrochloride
Labeler pai holdings, llc dba pharmaceutical associates, inc. and dba pai pharma
Dosage Form TABLET
Routes
SUBLINGUAL
Active Ingredients

buprenorphine hydrochloride 2 mg/1

Manufacturer
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1019
Product ID 0121-1019_1ce64f53-ed3c-692a-e063-6394a90a86d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090622
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-10-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211019
Hyphenated Format 0121-1019

Supplemental Identifiers

RxCUI
351264 351265
UPC
0301212038301 0301211019301
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 ANDA090622 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0121-1019-30)
source: ndc

Packages (1)

0121-1019-30 30 TABLET in 1 BOTTLE (0121-1019-30)

Ingredients (1)

buprenorphine hydrochloride (2 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": "1ce64f53-ed3c-692a-e063-6394a90a86d2", "openfda": {"upc": ["0301212038301", "0301211019301"], "unii": ["56W8MW3EN1"], "rxcui": ["351264", "351265"], "spl_set_id": ["442831cf-9636-433a-9a12-e9a8cd31f72a"], "manufacturer_name": ["PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0121-1019-30)", "package_ndc": "0121-1019-30", "marketing_start_date": "20231012"}], "brand_name": "buprenorphine hydrochloride", "product_id": "0121-1019_1ce64f53-ed3c-692a-e063-6394a90a86d2", "dosage_form": "TABLET", "pharm_class": ["Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0121-1019", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride", "labeler_name": "PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "buprenorphine hydrochloride", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA090622", "marketing_category": "ANDA", "marketing_start_date": "20231012", "listing_expiration_date": "20261231"}