Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0527-1651
- 11-digit product format
- 005271651
- Labeler code
- 0527
- Product ID
- 0527-1651_d5934157-d60d-4f4a-8320-fba9e1212f1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA207172
- Marketing category
- ANDA
- Marketing start
- 2017-06-22
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- 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 |
|---|
| 0527-1651-01 | 00527165101 | 100 TABLET in 1 BOTTLE (0527-1651-01) | 100 tablet | 2017-06-22 | 0000-00-00 | No | No | Current |
| 0527-1651-05 | 00527165105 | 500 TABLET in 1 BOTTLE (0527-1651-05) | 500 tablet | 2017-06-22 | 0000-00-00 | No | No | Current |