IBUPROFEN
- Product NDC
- 49483-601
- 11-digit product format
- 494830601
- Labeler code
- 49483
- Product ID
- 49483-601_375d8923-4e92-d631-e063-6294a90a20eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES,INC
- Application
- ANDA091239
- Marketing category
- ANDA
- Marketing start
- 2016-03-22
- 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 |
|---|
| 49483-601-00 | IBUPROFEN | 6500 in 1 BAG | TABLET, FILM COATED | 6500 | | 12 |
| 49483-601-01 | IBUPROFEN | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 12 |
| 49483-601-05 | IBUPROFEN | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 12 |
| 49483-601-10 | IBUPROFEN | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 49483-601-50 | IBUPROFEN | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49483-601 | IBUPROFEN TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED IBUPROFEN (IBUPFROFEN) TABLET, FILM COATED [TIME CAP LABORATORIES,INC] | 11 | Current NDC, Legacy NDC, 5 package rows | 20231123_f58d35f9-e44b-417b-98ce-0766b537cd2f.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 |
|---|
| 49483-601-00 | 49483060100 | 6500 TABLET, FILM COATED in 1 BAG (49483-601-00) | 2016-03-22 | 0000-00-00 | No | No | Current |
| 49483-601-01 | 49483060101 | 100 TABLET, FILM COATED in 1 BOTTLE (49483-601-01) | 2016-03-22 | 0000-00-00 | No | No | Current |
| 49483-601-05 | 49483060105 | 50 TABLET, FILM COATED in 1 BOTTLE (49483-601-05) | 2016-03-22 | 0000-00-00 | No | No | Current |
| 49483-601-10 | 49483060110 | 1000 TABLET, FILM COATED in 1 BOTTLE (49483-601-10) | 2016-03-22 | 0000-00-00 | No | No | Current |
| 49483-601-50 | 49483060150 | 500 TABLET, FILM COATED in 1 BOTTLE (49483-601-50) | 2016-03-22 | 0000-00-00 | No | No | Current |