BUPAP
- Product NDC
- 0095-3000
- 11-digit product format
- 000953000
- Labeler code
- 0095
- Product ID
- 0095-3000_16609ec3-578a-4f92-83d4-85d58e23cd8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Butalbital and Acetaminophen Tablets
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- ANDA090956
- Marketing category
- ANDA
- Marketing start
- 2013-06-24
- Marketing end
- 0000-00-00
- Substance
- BUTALBITAL; ACETAMINOPHEN
- Active strength
- 50 mg/1; mg/1
- Pharmacologic classes
- Barbiturates [CS],Barbiturate [EPC]
- 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 |
|---|
| 0095-3000-01 | 00095300001 | 100 TABLET in 1 BOTTLE, PLASTIC (0095-3000-01) | 100 tablet | 2013-06-24 | 0000-00-00 | No | No | Current |
| 0095-3000-09 | 00095300009 | 1 TABLET in 1 POUCH (0095-3000-09) | 1 tablet | 2013-06-24 | 0000-00-00 | No | No | Current |