NDC 70377-019

FINGOLIMOD

Fingolimod

FINGOLIMOD is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Biocon Pharma Inc.. The primary component is Fingolimod Hydrochloride.

Product ID70377-019_a96febc3-5c72-9a72-d34c-b6a319124c06
NDC70377-019
Product TypeHuman Prescription Drug
Proprietary NameFINGOLIMOD
Generic NameFingolimod
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2020-02-10
Marketing CategoryANDA / ANDA
Application NumberANDA207979
Labeler NameBiocon Pharma 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 70377-019-21

28 CAPSULE in 1 CARTON (70377-019-21)
Marketing Start Date2020-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70377-019-21 [70377001921]

FINGOLIMOD CAPSULE
Marketing CategoryANDA
Application NumberANDA207979
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-10

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"

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.