FDA.reportPublic FDA data

Fingolimod

Product NDC
60505-4332
11-digit product format
605054332
Labeler code
60505
Product ID
60505-4332_308bc432-976f-c1eb-e2fb-bd2ec51f22cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA207993
Marketing category
ANDA
Marketing start
2022-10-18
Substance
FINGOLIMOD HYDROCHLORIDE
Active strength
.5 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fingolimod
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FINGOLIMOD HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG926EC510T
Rxcui1012895

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
665f4aef-df96-42b3-97d1-5971737de3dcProduct name920250121
6b6bc7ea-a5a8-4e5e-b81d-4b6b4cbe6f45Product name120230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4332-1Fingolimod1 in 1 CARTONCAPSULE18
60505-4332-1Fingolimod28 in 1 BLISTER PACKCAPSULE288
60505-4332-3Fingolimod30 in 1 BOTTLECAPSULE308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4332-3EA - Each60505-43328fafc872-addc-4dd6-9fa9-7212acd16dde12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4332FINGOLIMOD CAPSULE [APOTEX CORP.]7Current NDC, Legacy NDC, 3 package rows20250209_a545c6fc-7006-52c2-f476-34e9801ac04f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSNa545c6fc-7006-52c2-f476-34e9801ac04f8
1012895fingolimod 0.5 MG Oral CapsuleSCDa545c6fc-7006-52c2-f476-34e9801ac04f8
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSYa545c6fc-7006-52c2-f476-34e9801ac04f8
1012895fingolimod 500 MCG Oral CapsuleSYa545c6fc-7006-52c2-f476-34e9801ac04f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4332-1605054332011 in 1 CARTONHistorical
60505-4332-36050543320330 CAPSULE in 1 BOTTLE (60505-4332-3) 30 capsule2022-10-180000-00-00NoNoCurrent