Ibuprofen
- Product NDC
- 49483-602
- 11-digit product format
- 494830602
- Labeler code
- 49483
- Product ID
- 49483-602_27b8b074-c62d-7214-e063-6294a90adb69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- Substance
- IBUPROFEN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-602-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 8 |
| 49483-602-50 | Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-602 | IBUPROFEN TABLET, FILM COATED [TIME CAP LABORATORIES, INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241130_ec3e8443-d742-4c25-8516-f0df4ebfccdc.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 |
|---|
| 49483-602-01 | 49483060201 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-602-01) | 2015-12-30 | 0000-00-00 | No | No | Current |
| 49483-602-50 | 49483060250 | 500 TABLET, FILM COATED in 1 BOTTLE (49483-602-50) | 2015-12-30 | 0000-00-00 | No | No | Current |