# Buprenorphine and Naloxone

NDC: 0121-1018
Generic name: buprenorphine hydrochloride and naloxone hydrochloride
Labeler / Manufacturer: PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: SUBLINGUAL
Marketing started: 20230905

FDA application: ANDA204431

## Active ingredients

- BUPRENORPHINE HYDROCHLORIDE: 2 mg/1
- NALOXONE HYDROCHLORIDE: .5 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0121-1018"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0121-1018
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d5b011ef-f1be-47f2-8f8b-07553f36193c