Febuxostat
- Product NDC
- 0904-7485
- 11-digit product format
- 009047485
- Labeler code
- 0904
- Product ID
- 0904-7485_2bc97ac5-e672-4bb9-b0c4-596bbe935292
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA210461
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- Marketing end
- 2026-08-31
- Substance
- FEBUXOSTAT
- Active strength
- 80 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Febuxostat
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 |
|---|
| 0904-7485-03 | Febuxostat | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7485 | FEBUXOSTAT TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 1 package rows | 20240927_164feabd-f722-445b-b81a-d975b3db5f53.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 |
|---|
| 0904-7485-03 | 00904748503 | 30 TABLET, FILM COATED in 1 BOTTLE (0904-7485-03) | 2024-05-22 | 2026-08-31 | No | No | Historical |