Ibuprofen
- Product NDC
- 0121-0918
- 11-digit product format
- 001210918
- Labeler code
- 0121
- Product ID
- 0121-0918_d30c087d-a4bf-d940-e053-2995a90a1588
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA209204
- Marketing category
- ANDA
- Marketing start
- 2017-06-23
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 0121-0918-40 | 00121091840 | 4 TRAY in 1 CASE (0121-0918-40) > 10 PACKAGE in 1 TRAY > 1 mL in 1 PACKAGE (0121-0918-15) | 4 tray | 2020-11-19 | 0000-00-00 | No | No | Current |
| 0121-0918-50 | 00121091850 | 5 TRAY in 1 CASE (0121-0918-50) > 10 PACKAGE in 1 TRAY > 1 mL in 1 PACKAGE (0121-0918-15) | 5 tray | 2020-11-19 | 0000-00-00 | No | No | Current |