Ibuprofen
- Product NDC
- 68071-3589
- 11-digit product format
- 680713589
- Labeler code
- 68071
- Product ID
- 68071-3589_141b6717-62ab-4bfb-e063-6394a90a884d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA209178
- Marketing category
- ANDA
- Marketing start
- 2018-02-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-3589-4 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
| 68071-3589-4 | Ibuprofen | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3589 | IBUPROFEN SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, 2 package rows | 20240322_141b7964-cce6-74e4-e063-6294a90af746.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3589-4 | 68071358904 | 1 BOTTLE in 1 CARTON (68071-3589-4) / 120 mL in 1 BOTTLE | 1 bottle | 2024-03-20 | No | No | Current |