# Buprenorphine and Naloxone

NDC: 0378-8766
Generic name: Buprenorphine and Naloxone
Labeler / Manufacturer: Mylan Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: FILM
Routes: BUCCAL, SUBLINGUAL
Marketing started: 20200417

FDA application: ANDA211785

## Active ingredients

- BUPRENORPHINE HYDROCHLORIDE: 4 mg/1
- NALOXONE HYDROCHLORIDE DIHYDRATE: 1 mg/1

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0378-8766"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0378-8766
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=557d8d4d-8751-431c-b18e-9d5cf23fc579
