# buprenorphine hydrochloride and naloxone hydrochloride dihydrate

NDC: 0054-0188
Generic name: buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Labeler / Manufacturer: Hikma Pharmaceuticals USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: SUBLINGUAL
Marketing started: 20140627

FDA application: ANDA203326

## 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:"0054-0188"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0054-0188
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=713db2c6-0544-4633-b874-cfbeaf93db89