Hydrocodone bitartrate and ibuprofen
- Product NDC
- 57664-280
- 11-digit product format
- 576640280
- Labeler code
- 57664
- Product ID
- 57664-280_5fc8dccb-c6eb-0b9a-e053-2a91aa0a7bad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone bitartrate and ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091633
- Marketing category
- ANDA
- Marketing start
- 2013-05-28
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record