NDC 67877-476

Fingolimod

Fingolimod Hydrochloride

Fingolimod is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Fingolimod Hydrochloride.

Product ID67877-476_1517df0f-8d15-4abc-b49f-e85dbad10cee
NDC67877-476
Product TypeHuman Prescription Drug
Proprietary NameFingolimod
Generic NameFingolimod Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-09-21
Marketing CategoryANDA /
Application NumberANDA208004
Labeler NameAscend Laboratories, LLC
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 67877-476-30

30 CAPSULE in 1 BOTTLE (67877-476-30)
Marketing Start Date2022-09-21
NDC Exclude FlagN
Sample Package?N

Drug Details

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

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.