Febuxostat
- Product NDC
- 0054-0414
- 11-digit product format
- 000540414
- Labeler code
- 0054
- Product ID
- 0054-0414_bbddff32-f902-4e38-94fb-a1b903d69ee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc
- Application
- ANDA205414
- Marketing category
- ANDA
- Marketing start
- 2019-11-11
- 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 |
|---|
| 0054-0414-13 | Febuxostat | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0414 | FEBUXOSTAT TABLET [HIKMA PHARMACEUTICALS USA INC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230608_14f1555c-2565-42c7-b3f5-dd5f03fed67a.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 |
|---|
| 0054-0414-13 | 00054041413 | 30 TABLET in 1 BOTTLE (0054-0414-13) | 30 tablet | 2019-11-11 | 0000-00-00 | No | No | Current |