IBUPROFEN
- Product NDC
- 49483-611
- 11-digit product format
- 494830611
- Labeler code
- 49483
- Product ID
- 49483-611_20b8a0bc-778a-7848-e063-6394a90ad512
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES,INC
- Application
- ANDA091237
- Marketing category
- ANDA
- Marketing start
- 2016-11-16
- Substance
- IBUPROFEN
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-611-00 | IBUPROFEN | 6500 in 1 BAG | TABLET, FILM COATED | 6500 | | 2 |
| 49483-611-01 | IBUPROFEN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 49483-611-05 | IBUPROFEN | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-611 | IBUPROFEN TABLET, FILM COATED [TIME CAP LABORATORIES,INC] | 2 | Current NDC, Legacy NDC, 3 package rows | 20250215_82aad715-f652-471b-840c-5151c66e5ade.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 |
|---|
| 49483-611-00 | 49483061100 | 6500 TABLET, FILM COATED in 1 BAG (49483-611-00) | 2016-11-16 | 0000-00-00 | No | No | Current |
| 49483-611-01 | 49483061101 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-611-01) | 2016-11-16 | 0000-00-00 | No | No | Current |
| 49483-611-05 | 49483061105 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-611-05) | 2016-11-16 | 0000-00-00 | No | No | Current |