Ibuprofen
- Product NDC
- 68071-3793
- 11-digit product format
- 680713793
- Labeler code
- 68071
- Product ID
- 68071-3793_4d639377-2953-5858-e063-6394a90a5d85
- 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
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
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 |
|---|
| 68071-3793-1 | Ibuprofen | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 5 |
| 68071-3793-3 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 68071-3793-5 | Ibuprofen | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 5 |
| 68071-3793-6 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3793 | IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 3 | Current NDC, 4 package rows | 20250409_2e0f74a5-b8f3-fc81-e063-6394a90a647a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3793-1 | 68071379301 | 21 TABLET, FILM COATED in 1 BOTTLE (68071-3793-1) | 2025-04-07 | No | No | Historical |
| 68071-3793-3 | 68071379303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3793-3) | 2025-02-13 | No | No | Historical |
| 68071-3793-5 | 68071379305 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3793-5) | 2025-03-11 | No | No | Historical |
| 68071-3793-6 | 68071379306 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3793-6) | 2025-02-13 | No | No | Historical |