NDC 0078-0607

Gilenya

Fingolimod Hcl

Gilenya is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Fingolimod Hydrochloride.

• Product ID: 0078-0607_242ee18e-e5e6-4ad3-a660-6691ea7c0816
• NDC: 0078-0607
• Product Type: Human Prescription Drug
• Proprietary Name: Gilenya
• Generic Name: Fingolimod Hcl
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2010-09-21
• Marketing Category: NDA / NDA
• Application Number: NDA022527
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: FINGOLIMOD HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0607-15

30 CAPSULE in 1 BOTTLE (0078-0607-15)

• Marketing Start Date: 2010-09-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0607-51 [00078060751]

Gilenya CAPSULE

• Marketing Category: NDA
• Application Number: NDA022527
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-21
• Marketing End Date: 2016-11-30

NDC 0078-0607-89 [00078060789]

Gilenya CAPSULE

• Marketing Category: NDA
• Application Number: NDA022527
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-21

NDC 0078-0607-15 [00078060715]

Gilenya CAPSULE

• Marketing Category: NDA
• Application Number: NDA022527
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-21

Drug Details

Active Ingredients

Ingredient	Strength
FINGOLIMOD HYDROCHLORIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: cc9e1c8c-0e2b-44e2-878b-27057f786be9
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • G926EC510T
• RxNorm Concept Unique ID - RxCUI:
  • 2045491
  • 2045493
  • 1012895
  • 1012899

Pharmacological Class

• Sphingosine 1-Phosphate Receptor Modulators [MoA]
• Sphingosine 1-phosphate Receptor Modulator [EPC]

NDC Crossover Matching brand name "Gilenya" or generic name "Fingolimod Hcl"

NDC	Brand Name	Generic Name
0078-0607	Gilenya	Fingolimod hcl
0078-0965	Gilenya	Fingolimod hcl
64980-449	fingolimod	Fingolimod hcl