NDC 64380-776

FINGOLIMOD

Fingolimod

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

Product ID64380-776_5404ed8d-1fee-4b0c-b5f9-e63a61675e43
NDC64380-776
Product TypeHuman Prescription Drug
Proprietary NameFINGOLIMOD
Generic NameFingolimod
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-11-15
Marketing CategoryANDA /
Application NumberANDA207971
Labeler NameStrides Pharma Science Limited
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 Through2023-12-31

Packaging

NDC 64380-776-04

1 BOTTLE in 1 CARTON (64380-776-04) > 30 CAPSULE in 1 BOTTLE
Marketing Start Date2022-11-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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