Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 55700-639
- 11-digit product format
- 557000639
- Labeler code
- 55700
- Product ID
- 55700-639_fa854a4c-15d8-497b-b6fc-8662165dcdf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA077723
- Marketing category
- ANDA
- Marketing start
- 2018-06-15
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 8 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
- 2020-12-31
- 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 |
|---|
| 55700-639-60 | 55700063960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-639-60) | 2018-06-15 | 0000-00-00 | No | No | Current |