butalbital and acetaminophen
- Product NDC
- 51862-544
- 11-digit product format
- 518620544
- Labeler code
- 51862
- Product ID
- 51862-544_ed0bd699-c248-60f4-e053-2995a90a781f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- butalbital and acetaminophen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- ANDA207313
- Marketing category
- ANDA
- Marketing start
- 2018-07-30
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51862-544 | BUTALBITAL AND ACETAMINOPHEN CAPSULE [MAYNE PHARMA] | 7 | Legacy NDC | 20250110_c45b797e-62b2-4944-989e-c17b4204ffdb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-544-01 | 51862054401 | 100 CAPSULE in 1 BOTTLE (51862-544-01) | 100 capsule | 2018-07-30 | 0000-00-00 | No | No | Current |
| 51862-544-05 | 51862054405 | 500 CAPSULE in 1 BOTTLE (51862-544-05) | 500 capsule | 2018-07-30 | 0000-00-00 | No | No | Current |