butalbital and acetaminophen
- Product NDC
- 51862-538
- 11-digit product format
- 518620538
- Labeler code
- 51862
- Product ID
- 51862-538_ea236635-660a-b493-e053-2995a90a6b47
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- ANDA207386
- Marketing category
- ANDA
- Marketing start
- 2017-02-13
- Marketing end
- 2023-11-30
- 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
- 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 |
|---|
| 51862-538-01 | 51862053801 | 100 TABLET in 1 BOTTLE (51862-538-01) | 100 tablet | 2017-02-13 | 0000-00-00 | No | No | Current |