# HYDROCODONE BITARTRATE AND ACETAMINOPHEN

NDC: 0054-0843
Generic name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Labeler / Manufacturer: Hikma Pharmaceuticals USA Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: LIQUID
Routes: ORAL
Marketing started: 20250602

FDA application: ANDA040881

## Active ingredients

- ACETAMINOPHEN: 300 mg/15mL
- HYDROCODONE BITARTRATE: 10 mg/15mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0054-0843"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0054-0843
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=995a6cc7-8b72-4d35-b3b4-8c5752438fb7