Febuxostat
- Product NDC
- 27808-207
- 11-digit product format
- 278080207
- Labeler code
- 27808
- Product ID
- 27808-207_7a3e937f-5938-4fa5-87da-3cbf111e582e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Tris Pharma Inc
- Application
- ANDA210292
- Marketing category
- ANDA
- Marketing start
- 2020-09-28
- 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 |
|---|
| 27808-207-01 | Febuxostat | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-207 | FEBUXOSTAT TABLET [TRIS PHARMA INC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230627_d3b18653-9487-4a78-82c0-80ee024b8ef6.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 |
|---|
| 27808-207-01 | 27808020701 | 30 TABLET in 1 BOTTLE (27808-207-01) | 30 tablet | 2020-09-28 | 0000-00-00 | No | No | Current |