Quick answers
- What is Butal/Apap/Caffeine?
- Butal/Apap/Caffeine is a brand name of Butalbital, acetaminophen and caffeine, a prescription medicine. The FDA NDC Directory lists 1 Butal/Apap/Caffeine product in 1 strength and form.
- Who makes Butal/Apap/Caffeine?
- LGM Pharma holds the FDA application for Butal/Apap/Caffeine (ANDA209587, approved October 31, 2018).
- Is there a generic or store brand of Butal/Apap/Caffeine?
- Yes. The FDA NDC Directory lists 42 other products with the same active ingredients, strength and form as a Butal/Apap/Caffeine product, 42 of them generic. Ask your pharmacist whether one is right for you.
- Has Butal/Apap/Caffeine been recalled?
- No recall linked to Butal/Apap/Caffeine products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Butal/Apap/Caffeine is
Each Butal/Apap/Caffeine product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Butalbital, acetaminophen and caffeine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 325 mg · butalbital 50 mg · caffeine 40 mg tablet (oral) | Butal/Apap/Caffeine | 42 products, 25 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Butalbital, acetaminophen and caffeine →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA209587 | LGM Pharma | October 31, 2018 | 1 |
Companies that list Butal/Apap/Caffeine
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Butal/Apap/Caffeine products.
- Direct_Rx1 product
Recalls
No recall linked to Butal/Apap/Caffeine products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.