Butalbital, Acetaminophen, Caffeine
- Product NDC
- 68788-7882
- 11-digit product format
- 687887882
- Labeler code
- 68788
- Product ID
- 68788-7882_b3febdde-f352-4627-ba59-96a10f6ac8aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen, and Caffeine
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209587
- Marketing category
- ANDA
- Marketing start
- 2021-03-10
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7882-1 | 68788788201 | 100 TABLET, COATED in 1 BOTTLE (68788-7882-1) | 2021-03-10 | 0000-00-00 | No | No | Current |
| 68788-7882-2 | 68788788202 | 20 TABLET, COATED in 1 BOTTLE (68788-7882-2) | 2021-03-10 | 0000-00-00 | No | No | Current |
| 68788-7882-3 | 68788788203 | 30 TABLET, COATED in 1 BOTTLE (68788-7882-3) | 2021-03-10 | 0000-00-00 | No | No | Current |
| 68788-7882-6 | 68788788206 | 60 TABLET, COATED in 1 BOTTLE (68788-7882-6) | 2021-03-10 | 0000-00-00 | No | No | Current |
| 68788-7882-8 | 68788788208 | 120 TABLET, COATED in 1 BOTTLE (68788-7882-8) | 2021-03-10 | 0000-00-00 | No | No | Current |
| 68788-7882-9 | 68788788209 | 90 TABLET, COATED in 1 BOTTLE (68788-7882-9) | 2021-03-10 | 0000-00-00 | No | No | Current |