NDC 64980-449

fingolimod

Fingolimod Hcl

fingolimod is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rising Pharmaceuticals, Inc.. The primary component is Fingolimod Hydrochloride.

Product ID64980-449_a2c28ab8-f9d8-ef92-e053-2995a90abddb
NDC64980-449
Product TypeHuman Prescription Drug
Proprietary Namefingolimod
Generic NameFingolimod Hcl
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2021-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA207939
Labeler NameRising Pharmaceuticals, Inc.
Substance NameFINGOLIMOD HYDROCHLORIDE
Active Ingredient Strength1 mg/1
Pharm ClassesSphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 64980-449-03

30 CAPSULE in 1 BOTTLE (64980-449-03)
Marketing Start Date2021-01-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
FINGOLIMOD HYDROCHLORIDE.5 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0378-4525FingolimodFingolimod
31722-889FingolimodFingolimod
43547-003FINGOLIMODfingolimod
43598-285FingolimodFingolimod
60505-4332FingolimodFingolimod
62756-064FingolimodFingolimod
64380-776FINGOLIMODfingolimod
64980-449fingolimodFingolimod hcl
67877-476FingolimodFingolimod hydrochloride
68382-912FingolimodFingolimod
68462-166fingolimodfingolimod
70377-019FINGOLIMODFINGOLIMOD
70771-1603FingolimodFingolimod
0078-0607GilenyaFingolimod hcl
0078-0965GilenyaFingolimod hcl

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.