BUTALBITAL AND ACETAMINOPHEN
- Product NDC
- 71406-109
- 11-digit product format
- 714060109
- Labeler code
- 71406
- Product ID
- 71406-109_f0d2490a-138b-34b8-e053-2a95a90a2fc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AACE Pharmaceuticals, Inc.
- Application
- ANDA214955
- Marketing category
- ANDA
- Marketing start
- 2021-10-07
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; BUTALBITAL
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Barbiturate [EPC], Barbiturates [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 71406-109-03 | 71406010903 | 30 TABLET in 1 BOTTLE (71406-109-03) | 30 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |
| 71406-109-05 | 71406010905 | 500 TABLET in 1 BOTTLE (71406-109-05) | 500 tablet | 2021-10-07 | 0000-00-00 | No | No | Current |