Ibuprofen
- Product NDC
- 70518-4595
- 11-digit product format
- 705184595
- Labeler code
- 70518
- Product ID
- 70518-4595_4dc63099-bda6-c9ae-e063-6394a90af398
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209204
- Marketing category
- ANDA
- Marketing start
- 2026-03-24
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4595-0 | Ibuprofen | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 1 |
| 70518-4595-0 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4595-0 | 70518459500 | 1 BOTTLE in 1 CARTON (70518-4595-0) / 118 mL in 1 BOTTLE | 1 bottle | 2026-03-24 | No | No | Current |