NDC 47335-722

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Febuxostat.

• Product ID: 47335-722_bdb4de18-f355-4237-bf11-1745f8f998c8
• NDC: 47335-722
• Product Type: Human Prescription Drug
• Proprietary Name: Febuxostat
• Generic Name: Febuxostat
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205467
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: FEBUXOSTAT
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47335-722-18

1000 TABLET, FILM COATED in 1 BOTTLE (47335-722-18)

• Marketing Start Date: 2019-07-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47335-722-18 [47335072218]

Febuxostat TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA205467
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-05

NDC 47335-722-83 [47335072283]

Febuxostat TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA205467
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-05

NDC 47335-722-88 [47335072288]

Febuxostat TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA205467
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-05

Drug Details

Active Ingredients

Ingredient	Strength
FEBUXOSTAT	80 mg/1

OpenFDA Data

• SPL SET ID: 1f7541bd-bf32-422b-b99a-89193cf193ca
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 101V0R1N2E
• RxNorm Concept Unique ID - RxCUI:
  • 834241
  • 834235
• UPC Code:
  • 0347335654233

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
63304-865	Febuxostat	Febuxostat
69539-036	Febuxostat	Febuxostat
69539-035	Febuxostat	Febuxostat
71610-386	Febuxostat	Febuxostat
71610-411	Febuxostat	Febuxostat
72205-028	Febuxostat	Febuxostat
72205-029	Febuxostat	Febuxostat
71610-450	Febuxostat	Febuxostat
68071-5271	Febuxostat	Febuxostat
21695-516	ULORIC	febuxostat
43353-305	ULORIC	febuxostat
55154-5158	ULORIC	febuxostat
55154-5159	ULORIC	febuxostat