Febuxostat
- Product NDC
- 0904-7396
- 11-digit product format
- 009047396
- Labeler code
- 0904
- Product ID
- 0904-7396_2a8a681c-a419-43c5-b5ba-f6596aeb6677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MAJOR PHARMACEUTICALS
- Application
- ANDA210461
- Marketing category
- ANDA
- Marketing start
- 2019-12-30
- 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 |
|---|
| 0904-7396-46 | Febuxostat | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7396 | FEBUXOSTAT TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 2 | Current NDC, 1 package rows | 20240702_13a80059-46f7-4453-ab37-72744657a08a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7396-46 | 00904739646 | 30 TABLET, FILM COATED in 1 BOTTLE (0904-7396-46) | 2023-12-01 | No | No | Current |