Concentrated ibuprofen infants
- Product NDC
- 83324-005
- 11-digit product format
- 833240005
- Labeler code
- 83324
- Product ID
- 83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION/ DROPS
- Route
- ORAL
- Labeler
- Chain Drug Marketing Association Inc.
- Application
- ANDA210755
- Marketing category
- ANDA
- Marketing start
- 2023-11-03
- Substance
- IBUPROFEN
- Active strength
- 50 mg/1.25mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83324-005-30 | 83324000530 | 1 BOTTLE in 1 CARTON (83324-005-30) / 30 mL in 1 BOTTLE | 1 bottle | 2023-11-03 | No | No | Historical |