Butalbital, Acetaminophen and Caffeine
- Product NDC
- 42543-094
- 11-digit product format
- 425430094
- Labeler code
- 42543
- Product ID
- 42543-094_20aaf869-938f-4c08-b157-f4fcaef92996
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital, Acetaminophen and Caffeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Inc.
- Application
- ANDA203647
- Marketing category
- ANDA
- Marketing start
- 2021-12-31
- 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42543-094-01 | 42543009401 | 100 TABLET in 1 BOTTLE (42543-094-01) | 100 tablet | 2021-12-31 | 0000-00-00 | No | No | Current |
| 42543-094-05 | 42543009405 | 500 TABLET in 1 BOTTLE (42543-094-05) | 500 tablet | 2021-12-31 | 0000-00-00 | No | No | Current |