NDC 16729-342

FINGOLIMOD HYDROCHLORIDE

Fingolimod Hydrochloride

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

Product ID16729-342_eb7626a6-adbf-2c53-e053-2a95a90a3a14
NDC16729-342
Product TypeHuman Prescription Drug
Proprietary NameFINGOLIMOD HYDROCHLORIDE
Generic NameFingolimod Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2022-10-18
Marketing CategoryANDA /
Application NumberANDA207991
Labeler NameAccord Healthcare 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 16729-342-10

30 CAPSULE in 1 BOTTLE (16729-342-10)
Marketing Start Date2022-10-18
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
16729-342FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDE
67877-476FingolimodFingolimod hydrochloride

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