Ibuprofen
- Product NDC
- 42291-339
- 11-digit product format
- 422910339
- Labeler code
- 42291
- Product ID
- 42291-339_a5771a01-4e19-a874-e053-2a95a90a11a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE, Inc.
- Application
- ANDA078558
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 42291-339-50 | 42291033950 | 500 TABLET in 1 BOTTLE (42291-339-50) | 500 tablet | 2013-01-24 | 0000-00-00 | No | No | Current |