Febuxostat
- Product NDC
- 16714-060
- 11-digit product format
- 167140060
- Labeler code
- 16714
- Product ID
- 16714-060_0284b7a5-7a1f-4e37-9883-b7bdba68c42b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Febuxostat
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA205467
- Marketing category
- ANDA
- Marketing start
- 2021-01-26
- 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 |
|---|
| 16714-060-01 | 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 |
|---|
| 16714-060 | FEBUXOSTAT TABLET, FILM COATED [NORTHSTAR RXLLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20231122_ad40e0f6-850c-429a-87fc-f1eb2361e962.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 |
|---|
| 16714-060-01 | 16714006001 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-060-01) | 2021-01-26 | 0000-00-00 | No | No | Current |