NDC 0078-0979

MAYZENT

Siponimod

MAYZENT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Siponimod.

• Product ID: 0078-0979_10891f4a-a4d8-4d40-ae51-16cc9e104d36
• NDC: 0078-0979
• Product Type: Human Prescription Drug
• Proprietary Name: MAYZENT
• Generic Name: Siponimod
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-26
• Marketing Category: NDA / NDA
• Application Number: NDA209884
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: SIPONIMOD
• Active Ingredient Strength: 0 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0979-12

12 TABLET, FILM COATED in 1 BLISTER PACK (0078-0979-12)

• Marketing Start Date: 2019-03-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0979-12 [00078097912]

MAYZENT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209884
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-26

NDC 0078-0979-92 [00078097992]

MAYZENT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209884
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-26

NDC 0078-0979-50 [00078097950]

MAYZENT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209884
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-03-26

Drug Details

Active Ingredients

Ingredient	Strength
SIPONIMOD	.25 mg/1

OpenFDA Data

• SPL SET ID: 44492772-5aed-4627-bd85-e8e89f308bb3
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • RR6P8L282I
• RxNorm Concept Unique ID - RxCUI:
  • 2121090
  • 2121098
  • 2121100
  • 2121096

NDC Crossover Matching brand name "MAYZENT" or generic name "Siponimod"

NDC	Brand Name	Generic Name
0078-0979	MAYZENT	siponimod
0078-0986	MAYZENT	siponimod
0078-1014	MAYZENT	siponimod