Butalbital, Acetaminophen, and Caffeine
- Product NDC
- 47781-625
- 11-digit product format
- 477810625
- Labeler code
- 47781
- Product ID
- 47781-625_ecd7e123-4a3d-77bd-1431-b2c2547ef718
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital, acetaminophen, and caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- ANDA204984
- Marketing category
- ANDA
- Marketing start
- 2017-01-30
- Marketing end
- 2022-08-01
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47781-625-01 | 47781062501 | 100 TABLET in 1 BOTTLE (47781-625-01) | 100 tablet | 2018-07-23 | 0000-00-00 | No | No | Current |
| 47781-625-05 | 47781062505 | 500 TABLET in 1 BOTTLE (47781-625-05) | 500 tablet | 2018-10-09 | 0000-00-00 | No | No | Current |