NDC 0378-4525

Fingolimod

Fingolimod

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

Product ID0378-4525_3f9827b7-f7b0-4c5a-a53d-b08641d45beb
NDC0378-4525
Product TypeHuman Prescription Drug
Proprietary NameFingolimod
Generic NameFingolimod
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-09-22
Marketing CategoryANDA /
Application NumberANDA208005
Labeler NameMylan 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 Through2023-12-31

Packaging

NDC 0378-4525-93

30 CAPSULE in 1 BOTTLE, PLASTIC (0378-4525-93)
Marketing Start Date2022-09-22
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0378-4525FingolimodFingolimod
64980-449fingolimodFingolimod hcl
67877-476FingolimodFingolimod hydrochloride
70377-019FINGOLIMODFINGOLIMOD

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.