Febuxostat
- Product NDC
- 55111-797
- 11-digit product format
- 551110797
- Labeler code
- 55111
- Product ID
- 55111-797_25711455-9482-c211-793c-6d09539f1c09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DR REDDY'S LABORATORIES LIMITED
- Application
- ANDA205374
- Marketing category
- ANDA
- Marketing start
- 2020-11-25
- Substance
- FEBUXOSTAT
- Active strength
- 80 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Febuxostat
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEBUXOSTAT | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 101V0R1N2E |
| Rxcui | 834235, 834241 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-797-01 | Febuxostat | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 55111-797-05 | Febuxostat | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 55111-797-30 | Febuxostat | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 55111-797-90 | Febuxostat | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-797 | FEBUXOSTAT TABLET [DR REDDY'S LABORATORIES LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20201125_ccf2c4b1-e9a3-c7b7-ac42-79e1988fc211.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-797-01 | 55111079701 | 100 TABLET in 1 BOTTLE (55111-797-01) | 100 tablet | 2020-11-25 | 0000-00-00 | No | No | Current |
| 55111-797-05 | 55111079705 | 500 TABLET in 1 BOTTLE (55111-797-05) | 500 tablet | 2020-11-25 | 0000-00-00 | No | No | Current |
| 55111-797-30 | 55111079730 | 30 TABLET in 1 BOTTLE (55111-797-30) | 30 tablet | 2020-11-25 | 0000-00-00 | No | No | Current |
| 55111-797-90 | 55111079790 | 90 TABLET in 1 BOTTLE (55111-797-90) | 90 tablet | 2020-11-25 | 0000-00-00 | No | No | Current |