IBU
- Product NDC
- 68071-3053
- 11-digit product format
- 680713053
- Labeler code
- 68071
- Product ID
- 68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- 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
- IBU
- 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, 206917 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3053 | IBU (IBUPROFEN) TABLET [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240720_678e2d16-33f3-67a7-e053-2991aa0a1132.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-3053-0 | 68071305300 | 12 TABLET in 1 BOTTLE (68071-3053-0) | 12 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |
| 68071-3053-1 | 68071305301 | 120 TABLET in 1 BOTTLE (68071-3053-1) | 120 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |
| 68071-3053-2 | 68071305302 | 20 TABLET in 1 BOTTLE (68071-3053-2) | 20 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |
| 68071-3053-4 | 68071305304 | 40 TABLET in 1 BOTTLE (68071-3053-4) | 40 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |
| 68071-3053-6 | 68071305306 | 60 TABLET in 1 BOTTLE (68071-3053-6) | 60 tablet | 2018-03-16 | 0000-00-00 | No | No | Current |