buprenorphine and naloxone

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

buprenorphine hydrochloride 8 mg/1, naloxone hydrochloride 2 mg/1

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

Identifiers & Regulatory

Product NDC 0121-2036
Product ID 0121-2036_1ce649e8-2297-57de-e063-6394a90af242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204431
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-09-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01212036
Hyphenated Format 0121-2036

Supplemental Identifiers

RxCUI
351266 351267
UPC
0301211018304 0301212036307
UNII
56W8MW3EN1 F850569PQR

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 and naloxone (source: ndc)
Generic Name buprenorphine hydrochloride and naloxone hydrochloride (source: ndc)
Application Number ANDA204431 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30)
source: ndc

Packages (1)

0121-2036-30 30 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30)

Ingredients (2)

buprenorphine hydrochloride (8 mg/1) naloxone hydrochloride (2 mg/1)

Linked Drug Pages (1)

Buprenorphine and Naloxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "1ce649e8-2297-57de-e063-6394a90af242", "openfda": {"upc": ["0301211018304", "0301212036307"], "unii": ["56W8MW3EN1", "F850569PQR"], "rxcui": ["351266", "351267"], "spl_set_id": ["d5b011ef-f1be-47f2-8f8b-07553f36193c"], "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, PLASTIC (0121-2036-30)", "package_ndc": "0121-2036-30", "marketing_start_date": "20230905"}], "brand_name": "Buprenorphine and Naloxone", "product_id": "0121-2036_1ce649e8-2297-57de-e063-6394a90af242", "dosage_form": "TABLET", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]", "Partial Opioid Agonist [EPC]", "Partial Opioid Agonists [MoA]"], "product_ndc": "0121-2036", "dea_schedule": "CIII", "generic_name": "buprenorphine hydrochloride and naloxone hydrochloride", "labeler_name": "PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Buprenorphine and Naloxone", "active_ingredients": [{"name": "BUPRENORPHINE HYDROCHLORIDE", "strength": "8 mg/1"}, {"name": "NALOXONE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA204431", "marketing_category": "ANDA", "marketing_start_date": "20230905", "listing_expiration_date": "20261231"}