# Buprenorphine HCl and Naloxone HCl

NDC: 65162-416
Generic name: Buprenorphine and Naloxone
Labeler / Manufacturer: Amneal Pharmaceuticals LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: SUBLINGUAL
Marketing started: 20130222

FDA application: ANDA203136

## Active ingredients

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

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"65162-416"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=65162-416
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=17b63f10-c9df-44be-80fa-6f1c305583b8