Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 0603-3586
- 11-digit product format
- 006033586
- Labeler code
- 0603
- Product ID
- 0603-3586_0bf35876-d107-487d-9908-588c8c50e3b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA077723
- Marketing category
- ANDA
- Marketing start
- 2006-11-06
- Marketing end
- 2022-05-31
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0603-3586-21 | 00603358621 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-3586-21) | 2006-11-06 | 2022-05-31 | No | No | Current |