Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0527-1647
- 11-digit product format
- 005271647
- Labeler code
- 0527
- Product ID
- 0527-1647_bfc6e882-7608-4572-8651-c47523e7acef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA207171
- Marketing category
- ANDA
- Marketing start
- 2017-06-20
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300 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 |
|---|
| 0527-1647-01 | 00527164701 | 100 TABLET in 1 BOTTLE (0527-1647-01) | 100 tablet | 2017-06-20 | 0000-00-00 | No | No | Current |
| 0527-1647-05 | 00527164705 | 500 TABLET in 1 BOTTLE (0527-1647-05) | 500 tablet | 2017-06-20 | 0000-00-00 | No | No | Current |