# BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

NDC: 80425-0497
Generic name: butalbital, acetaminophen and caffeine
Labeler / Manufacturer: Advanced Rx of Tennessee, LLC
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: CAPSULE
Routes: ORAL
Marketing started: 20250214

FDA application: ANDA214087

## Active ingredients

- ACETAMINOPHEN: 300 mg/1
- BUTALBITAL: 50 mg/1
- CAFFEINE: 40 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"80425-0497"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=80425-0497
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2e20e0ee-dd73-6287-e063-6294a90a03b1