# BUTALBITAL AND ACETAMINOPHEN

NDC: 35573-455
Generic name: butalbital and acetaminophen
Labeler / Manufacturer: Burel Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20221201

FDA application: ANDA214088

## Active ingredients

- ACETAMINOPHEN: 300 mg/1
- BUTALBITAL: 50 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"35573-455"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=35573-455
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0a8a6a16-b23f-45d2-b5d4-540264e74d14