Butalbital and Acetaminophen
- Product NDC
- 47781-628
- 11-digit product format
- 477810628
- Labeler code
- 47781
- Product ID
- 47781-628_4e1d4eda-23a4-cd51-8b9c-a900b52fcf49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Alvogen, Inc.
- Application
- ANDA205120
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- Marketing end
- 2022-11-01
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC]
- 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 |
|---|
| 47781-628-01 | 47781062801 | 100 TABLET in 1 BOTTLE (47781-628-01) | 100 tablet | 2018-10-09 | 0000-00-00 | No | No | Current |