FINGOLIMOD

Product NDC
64380-776
11-digit product format
643800776
Labeler code
64380
Product ID
64380-776_5404ed8d-1fee-4b0c-b5f9-e63a61675e43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA207971
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
0000-00-00
Substance
FINGOLIMOD HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-776-04643800776041 BOTTLE in 1 CARTON (64380-776-04) > 30 CAPSULE in 1 BOTTLE1 bottle2022-11-150000-00-00NoNoCurrent
64380-776-26643800776261 BLISTER PACK in 1 CARTON (64380-776-26) > 7 CAPSULE in 1 BLISTER PACK (64380-776-00) 1 blister pack2022-11-150000-00-00NoNoCurrent
64380-776-27643800776274 BLISTER PACK in 1 CARTON (64380-776-27) > 7 CAPSULE in 1 BLISTER PACK (64380-776-00) 4 blister pack2022-11-150000-00-00NoNoCurrent