IBUPROFEN
- Product NDC
- 68071-4243
- 11-digit product format
- 680714243
- Labeler code
- 68071
- Product ID
- 68071-4243_1a3c656f-95e9-0191-e063-6294a90a6d47
- 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
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197806 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4243-1 | IBUPROFEN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4243 | IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240608_6365b2d6-2337-70c0-e053-2a91aa0aa960.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 |
|---|
| 68071-4243-1 | 68071424301 | 100 TABLET, FILM COATED in 1 BOTTLE (68071-4243-1) | 2018-01-22 | 0000-00-00 | No | No | Current |