Ibuprofen
- Product NDC
- 68645-562
- 11-digit product format
- 686450562
- Labeler code
- 68645
- Product ID
- 68645-562_4c4a254e-39fd-1e60-e063-6294a90a2703
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- 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
- 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68645-562-59 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-562 | IBUPROFEN TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250418_5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a.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 |
|---|
| 68645-562-59 | 68645056259 | 60 TABLET, FILM COATED in 1 BOTTLE (68645-562-59) | 2015-12-21 | 0000-00-00 | No | No | Current |