butalbital, acetaminophen and caffeine
- Product NDC
- 63629-2087
- 11-digit product format
- 636292087
- Labeler code
- 63629
- Product ID
- 63629-2087_c2b01c51-d83c-4083-a237-16a3c7bc1707
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, acetaminophen and caffeine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212083
- Marketing category
- ANDA
- Marketing start
- 2019-12-17
- Substance
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Active strength
- 325; 50; 40 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| KHS0AZ4JVK | BUTALBITAL | 77-26-9 | BUTALBITAL |
| 3G6A5W338E | CAFFEINE | 58-08-2 | CAFFEINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-2087-1 | 63629208701 | 100 CAPSULE in 1 BOTTLE, PLASTIC (63629-2087-1) | 100 capsule | 2021-06-02 | No | No | Historical |