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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-433260505-4332-1DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207993-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207993-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207993-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207993-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FingolimodFINGOLIMODApotex Corp.a545c6fc-7006-52c2-f476-34e9801ac04f2025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207993
application number: ANDA207993
ndc (product): 60505-4332

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G926EC510TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012895Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a545c6fc-7006-52c2-f476-34e9801ac04fAvailable on FDA.report

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