Ibuprofen
- Product NDC
- 68071-3679
- 11-digit product format
- 680713679
- Labeler code
- 68071
- Product ID
- 68071-3679_214ded7d-d55c-8b44-e063-6394a90a1a0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3679-1 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3679 | IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240906_214e3b3e-87b9-9ff5-e063-6394a90ae96a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3679-1 | 68071367901 | 100 TABLET, FILM COATED in 1 BOTTLE (68071-3679-1) | 2024-09-04 | No | No | Current |