NDC 43353-305

ULORIC

Febuxostat

ULORIC is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Febuxostat.

• Product ID: 43353-305_196bf4ca-b625-424a-8c4f-6be167d2bd2e
• NDC: 43353-305
• 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: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: FEBUXOSTAT
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-305-60

90 TABLET in 1 BOTTLE (43353-305-60)

• Marketing Start Date: 2017-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-305-60 [43353030560]

ULORIC TABLET

• Marketing Category: NDA
• Application Number: NDA021856
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-07

Drug Details

Active Ingredients

Ingredient	Strength
FEBUXOSTAT	40 mg/1

OpenFDA Data

• SPL SET ID: 24ac0ee2-cd7b-4dda-a1bb-271e32331758
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 101V0R1N2E
• RxNorm Concept Unique ID - RxCUI:
  • 834239
  • 834235

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