United States · FDA National Drug Code directory
Butalbital, Acetaminophen, Caffeine
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 85534-0046_56cb6d59-e749-3f7c-e063-6394a90a92e7
- Product NDC
- 85534-0046
- Form
- TABLET
- Composition / generic term
- Butalbital, Acetaminophen, and Caffeine
- Labeler
- HAWAII REPACK, INC.
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20190305
- Source listing expiry
- 20271231
Source-listed ingredients
- BUTALBITAL — 50 mg/1
- ACETAMINOPHEN — 325 mg/1
- CAFFEINE — 40 mg/1
These values do not establish equivalence or a dose recommendation.
Packages
- 10 TABLET in 1 BOTTLE (85534-0046-0) · 85534-0046-0
- 12 TABLET in 1 BOTTLE (85534-0046-1) · 85534-0046-1
- 20 TABLET in 1 BOTTLE (85534-0046-2) · 85534-0046-2
- 30 TABLET in 1 BOTTLE (85534-0046-3) · 85534-0046-3
- 60 TABLET in 1 BOTTLE (85534-0046-4) · 85534-0046-4
- 90 TABLET in 1 BOTTLE (85534-0046-5) · 85534-0046-5
- 100 TABLET in 1 BOTTLE (85534-0046-6) · 85534-0046-6
- 120 TABLET in 1 BOTTLE (85534-0046-7) · 85534-0046-7
- 500 TABLET in 1 BOTTLE (85534-0046-8) · 85534-0046-8
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →