NDC 21695-516

ULORIC

Febuxostat

ULORIC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Febuxostat.

• Product ID: 21695-516_ae1e0d8a-03fc-419b-9d44-afa68fbd5681
• NDC: 21695-516
• Product Type: Human Prescription Drug
• Proprietary Name: ULORIC
• Generic Name: Febuxostat
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-02-13
• Marketing Category: NDA / NDA
• Application Number: NDA021856
• Labeler Name: Rebel Distributors Corp
• Substance Name: FEBUXOSTAT
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-516-30

30 TABLET in 1 BOTTLE (21695-516-30)

• Marketing Start Date: 2009-02-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-516-30 [21695051630]

ULORIC TABLET

• Marketing Category: NDA
• Application Number: NDA021856
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-02-13
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
FEBUXOSTAT	80 mg/1

OpenFDA Data

• SPL SET ID: ae1e0d8a-03fc-419b-9d44-afa68fbd5681
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 101V0R1N2E
• RxNorm Concept Unique ID - RxCUI:
  • 834243
  • 834241

Pharmacological Class

• Xanthine Oxidase Inhibitor [EPC]
• Xanthine Oxidase Inhibitors [MoA]

NDC Crossover Matching brand name "ULORIC" or generic name "Febuxostat"

NDC	Brand Name	Generic Name
21695-516	ULORIC	febuxostat
43353-305	ULORIC	febuxostat
55154-5158	ULORIC	febuxostat
55154-5159	ULORIC	febuxostat
64764-677	ULORIC	ULORIC
64764-918	ULORIC	ULORIC
0054-0413	Febuxostat	Febuxostat
0054-0414	Febuxostat	Febuxostat
0378-3925	Febuxostat	febuxostat
0378-3926	Febuxostat	febuxostat
0527-2244	FEBUXOSTAT	febuxostat
0527-2248	FEBUXOSTAT	febuxostat
14445-156	Febuxostat	Febuxostat
14445-157	Febuxostat	Febuxostat
16714-059	Febuxostat	Febuxostat
16714-060	Febuxostat	Febuxostat
27808-206	Febuxostat	febuxostat
27808-207	Febuxostat	febuxostat
43547-295	FEBUXOSTAT	febuxostat
43547-296	FEBUXOSTAT	febuxostat
46708-190	Febuxostat	febuxostat
46708-191	Febuxostat	febuxostat
47335-721	Febuxostat	Febuxostat
47335-722	Febuxostat	Febuxostat
48792-7905	FEBUXOSTAT	febuxostat
48792-7906	FEBUXOSTAT	febuxostat
51407-293	Febuxostat	Febuxostat
51407-294	Febuxostat	Febuxostat
55111-796	Febuxostat	Febuxostat
55111-797	Febuxostat	Febuxostat
60687-538	Febuxostat	Febuxostat
62332-190	Febuxostat	febuxostat
62332-191	Febuxostat	febuxostat
63304-864	Febuxostat	Febuxostat