Febuxostat
- Product NDC
- 46708-190
- 11-digit product format
- 467080190
- Labeler code
- 46708
- Product ID
- 46708-190_1d0ffd95-5afe-4f03-8ac9-706187144e98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA205421
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Substance
- FEBUXOSTAT
- Active strength
- 40 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 | 40 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 |
|---|
| 46708-190-08 | Febuxostat | 80 in 1 CARTON | TABLET, COATED | 80 | | 2 |
| 46708-190-10 | Febuxostat | 100 in 1 CARTON | TABLET, COATED | 100 | | 2 |
| 46708-190-30 | Febuxostat | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 2 |
| 46708-190-31 | Febuxostat | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
| 46708-190-91 | Febuxostat | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-190 | FEBUXOSTAT TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 5 package rows | 20230120_41a95424-046e-413b-a121-cd7335e67135.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 |
|---|
| 46708-190-08 | 46708019008 | 80 TABLET, COATED in 1 CARTON (46708-190-08) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 46708-190-10 | 46708019010 | 100 TABLET, COATED in 1 CARTON (46708-190-10) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 46708-190-30 | 46708019030 | 30 TABLET, COATED in 1 BOTTLE (46708-190-30) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 46708-190-31 | 46708019031 | 100 TABLET, COATED in 1 BOTTLE (46708-190-31) | 2019-07-01 | 0000-00-00 | No | No | Current |
| 46708-190-91 | 46708019091 | 1000 TABLET, COATED in 1 BOTTLE (46708-190-91) | 2019-07-01 | 0000-00-00 | No | No | Current |