Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 64376-648
- 11-digit product format
- 643760648
- Labeler code
- 64376
- Product ID
- 64376-648_a6b50936-c07e-426f-8b02-787c83792135
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA090415
- Marketing category
- ANDA
- Marketing start
- 2011-01-14
- Marketing end
- 2021-07-30
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 |
|---|
| 64376-648-01 | 64376064801 | 100 TABLET in 1 BOTTLE (64376-648-01) | 100 tablet | 2011-01-14 | 2021-07-30 | No | No | Current |
| 64376-648-05 | 64376064805 | 500 TABLET in 1 BOTTLE (64376-648-05) | 500 tablet | 2011-01-14 | 2021-07-30 | No | No | Current |