Febuxostat
- Product NDC
- 67877-668
- 11-digit product format
- 678770668
- Labeler code
- 67877
- Product ID
- 67877-668_6bb4d90a-bb0d-4a30-b673-ee8273bda1b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA212924
- Marketing category
- ANDA
- Marketing start
- 2021-12-08
- 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 |
|---|
| 67877-668-10 | Febuxostat | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 67877-668-30 | Febuxostat | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 67877-668-38 | Febuxostat | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 4 |
| 67877-668-38 | Febuxostat | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 67877-668-90 | Febuxostat | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-668 | FEBUXOSTAT TABLET, FILM COATED [ASCEND LABORATORIES, LLC] | 4 | Current NDC, Legacy NDC, 5 package rows | 20220915_154ad94e-b775-4a10-ab0f-2874a0782db9.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 |
|---|
| 67877-668-10 | 67877066810 | 1000 TABLET, FILM COATED in 1 BOTTLE (67877-668-10) | | 2021-12-08 | 0000-00-00 | No | No | Current |
| 67877-668-30 | 67877066830 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-668-30) | | 2021-12-08 | 0000-00-00 | No | No | Current |
| 67877-668-38 | 67877066838 | 10 BLISTER PACK in 1 CARTON (67877-668-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2021-12-08 | 0000-00-00 | No | No | Current |
| 67877-668-90 | 67877066890 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-668-90) | | 2021-12-08 | 0000-00-00 | No | No | Current |