ULORIC
- Product NDC
- 21695-516
- 11-digit product format
- 216950516
- Labeler code
- 21695
- Product ID
- 21695-516_ae1e0d8a-03fc-419b-9d44-afa68fbd5681
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- febuxostat
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021856
- Marketing category
- NDA
- Marketing start
- 2009-02-13
- Marketing end
- 0000-00-00
- Substance
- FEBUXOSTAT
- Active strength
- 80 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 253cf2a8-e060-f2e5-7334-8565436b95e4 | Product name | 6 | 20240213 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-516-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c4a-48b1-e053-8cdaa90a720a | These HIGHLIGHTS do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC. ULORIC (febuxostat) tablet for oral use Initial U.S. Approval: 2009 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-516-30 | ULORIC | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-516-30 | EA - Each | 21695-516 | fc5ac20c-9705-443f-b2b6-ab1f1e712fc5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| febuxostat | ACTIVE INGREDIENT | 101V0R1N2E | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| febuxostat | ACTIVE MOIETY | 101V0R1N2E | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ULORIC (FEBUXOSTAT) TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 834241 | febuxostat 80 MG Oral Tablet | PSN | ae1e0d8a-03fc-419b-9d44-afa68fbd5681 | 1 |
| 834243 | Uloric 80 MG Oral Tablet | PSN | ae1e0d8a-03fc-419b-9d44-afa68fbd5681 | 1 |
| 834243 | febuxostat 80 MG Oral Tablet [Uloric] | SBD | ae1e0d8a-03fc-419b-9d44-afa68fbd5681 | 1 |
| 834241 | febuxostat 80 MG Oral Tablet | SCD | ae1e0d8a-03fc-419b-9d44-afa68fbd5681 | 1 |
| 834243 | Uloric 80 MG Oral Tablet | SY | ae1e0d8a-03fc-419b-9d44-afa68fbd5681 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-516-30 | 21695051630 | 30 in 1 BOTTLE | Historical |