NDC 0310-1475

ZURAMPIC

Lesinurad

ZURAMPIC is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceutica. The primary component is Lesinurad.

• Product ID: 0310-1475_dbd438e3-a7fb-4e93-a2d6-89d8c0647ed1
• NDC: 0310-1475
• Product Type: Human Prescription Drug
• Proprietary Name: ZURAMPIC
• Generic Name: Lesinurad
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-08-11
• Marketing Category: NDA / NDA
• Application Number: NDA207988
• Labeler Name: AstraZeneca Pharmaceutica
• Substance Name: LESINURAD
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Urate Transport
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0310-1475-05

5 TABLET, FILM COATED in 1 BOTTLE (0310-1475-05)

• Marketing Start Date: 2016-10-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-1475-30 [00310147530]

ZURAMPIC TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207988
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-11
• Marketing End Date: 2018-10-31

NDC 0310-1475-90 [00310147590]

ZURAMPIC TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207988
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-12-22
• Marketing End Date: 2015-12-22

NDC 0310-1475-05 [00310147505]

ZURAMPIC TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA207988
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-03
• Marketing End Date: 2019-02-28

Drug Details

Active Ingredients

Ingredient	Strength
LESINURAD	200 mg/1

OpenFDA Data

• SPL SET ID: 92d614a3-760d-492c-930d-22f91ff016b1
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 09ERP08I3W
• RxNorm Concept Unique ID - RxCUI:
  • 1731036
  • 1731042

Pharmacological Class

• Urate Transporter 1 Inhibitor [EPC]
• Urate Transporter 1 Inhibitors [MoA]
• Cytochrome P450 3A Inducers [MoA]

NDC Crossover Matching brand name "ZURAMPIC" or generic name "Lesinurad"

NDC	Brand Name	Generic Name
0310-1475	ZURAMPIC	lesinurad
70785-011	Zurampic	lesinurad