ULORIC
- Product NDC
- 64764-918
- 11-digit product format
- 647640918
- Labeler code
- 64764
- Product ID
- 64764-918_16c36a5a-2f72-4df7-aa6f-1ca27a39404f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA021856
- Marketing category
- NDA
- Marketing start
- 2009-02-13
- 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
- ULORIC
- 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, 834239, 834241, 834243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| febuxostat | ACTIVE INGREDIENT | 101V0R1N2E | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| febuxostat | ACTIVE MOIETY | 101V0R1N2E | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64764-918 | ULORIC (FEBUXOSTAT) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 16 | Current NDC, Legacy NDC, 5 package rows | 20230502_54de10ef-fe5f-4930-b91d-6bbb04c664bd.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 |
|---|
| 64764-918-11 | 64764091811 | 10 BLISTER PACK in 1 CARTON (64764-918-11) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2009-02-13 | 0000-00-00 | No | No | Current |
| 64764-918-18 | 64764091818 | 500 TABLET in 1 BOTTLE (64764-918-18) | 500 tablet | 2009-02-13 | 0000-00-00 | No | No | Current |
| 64764-918-30 | 64764091830 | 30 TABLET in 1 BOTTLE (64764-918-30) | 30 tablet | 2009-02-13 | 0000-00-00 | No | No | Current |
| 64764-918-90 | 64764091890 | 90 TABLET in 1 BOTTLE (64764-918-90) | 90 tablet | 2009-02-13 | 0000-00-00 | No | No | Current |