NDC 46708-190

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Febuxostat.

• Product ID: 46708-190_41a95424-046e-413b-a121-cd7335e67135
• NDC: 46708-190
• Product Type: Human Prescription Drug
• Proprietary Name: Febuxostat
• Generic Name: Febuxostat
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205421
• Labeler Name: Alembic Pharmaceuticals Limited
• 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 46708-190-08

80 TABLET, COATED in 1 CARTON (46708-190-08)

• Marketing Start Date: 2019-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 46708-190-30 [46708019030]

Febuxostat TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA205421
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 46708-190-10 [46708019010]

Febuxostat TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA205421
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 46708-190-31 [46708019031]

Febuxostat TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA205421
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 46708-190-91 [46708019091]

Febuxostat TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA205421
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

NDC 46708-190-08 [46708019008]

Febuxostat TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA205421
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-01

Drug Details

Active Ingredients

Ingredient	Strength
FEBUXOSTAT	40 mg/1

OpenFDA Data

• SPL SET ID: 41a95424-046e-413b-a121-cd7335e67135
• Manufacturer:
  • Alembic Pharmaceuticals Limited
• UNII:
  • 101V0R1N2E
• RxNorm Concept Unique ID - RxCUI:
  • 834241
  • 834235

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