IBUPROFEN
- Product NDC
- 68071-5140
- 11-digit product format
- 680715140
- Labeler code
- 68071
- Product ID
- 68071-5140_2abe1780-d1e5-a90a-e063-6294a90a64ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- Substance
- IBUPROFEN
- Active strength
- 800 mg/1
- 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-5140-3 | IBUPROFEN | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 6 |
| 68071-5140-6 | IBUPROFEN | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5140 | IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250104_9b02607a-6fab-5205-e053-2a95a90afa26.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-5140-3 | 68071514003 | 3 TABLET, FILM COATED in 1 BOTTLE (68071-5140-3) | 2019-12-31 | 0000-00-00 | No | No | Current |
| 68071-5140-6 | 68071514006 | 6 TABLET, FILM COATED in 1 BOTTLE (68071-5140-6) | 2020-01-06 | 0000-00-00 | No | No | Current |