BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Product NDC
- 68788-8794
- 11-digit product format
- 687888794
- Labeler code
- 68788
- Product ID
- 68788-8794_91e50642-d278-47c6-944b-4ed907e87e6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA214287
- Marketing category
- ANDA
- Marketing start
- 2024-12-18
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| BUTALBITAL | 50 mg/1 |
| CAFFEINE | 40 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E |
| Rxcui | 238154 |
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 |
|---|
| 68788-8794-2 | 68788879402 | 20 TABLET in 1 BOTTLE, PLASTIC (68788-8794-2) | 20 tablet | 2024-12-18 | No | No | Current |
| 68788-8794-3 | 68788879403 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8794-3) | 30 tablet | 2024-12-18 | No | No | Current |