Ibuprofen
- Product NDC
- 42291-428
- 11-digit product format
- 422910428
- Labeler code
- 42291
- Product ID
- 42291-428_d57cc326-d854-0598-e053-2995a90acd95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2019-11-08
- 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
- 2023-12-31
- 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 |
|---|
| 42291-428-50 | 42291042850 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-428-50) | 2019-11-08 | 0000-00-00 | No | No | Current |