FDA.reportPublic FDA data

fingolimod

Product NDC
68462-166
11-digit product format
684620166
Labeler code
68462
Product ID
68462-166_6640fd85-57d1-4ec5-b555-8dce3037d409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA207985
Marketing category
ANDA
Marketing start
2022-09-28
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
2027-12-31
Current FDA listing
Yes

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
A207985-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207985-001AB

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 22:54:322026-06A207985-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-06-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207985-001AB1a50c72e98297…

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
fingolimodFINGOLIMODGlenmark Pharmaceuticals Inc., USA8fe14efd-8f61-40db-9069-bb17daf3261a2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207985
application number: ANDA207985
ndc (product): 68462-166

Additional Listing Data#

Finished product
Yes
Brand name base
fingolimod
Listing expiration
2027-12-31

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
8fe14efd-8f61-40db-9069-bb17daf3261aAvailable 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
68462-166-07fingolimod7 in 1 BLISTER PACKCAPSULE75
68462-166-07fingolimod7 in 1 CARTONCAPSULE75
68462-166-15fingolimod28 in 1 CARTONCAPSULE285
68462-166-30fingolimod30 in 1 BOTTLECAPSULE305
68462-166-41fingolimod14 in 1 CARTONCAPSULE145
68462-166-41fingolimod14 in 1 BLISTER PACKCAPSULE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-166-30EA - Each68462-1669f85449d-f304-43f5-ae8e-b24b1d24436a12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-166FINGOLIMOD CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 6 package rows20240724_8fe14efd-8f61-40db-9069-bb17daf3261a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSN8fe14efd-8f61-40db-9069-bb17daf3261a5
1012895fingolimod 0.5 MG Oral CapsuleSCD8fe14efd-8f61-40db-9069-bb17daf3261a5
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSY8fe14efd-8f61-40db-9069-bb17daf3261a5
1012895fingolimod 500 MCG Oral CapsuleSY8fe14efd-8f61-40db-9069-bb17daf3261a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-166-07684620166077 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK7 blister pack2022-09-280000-00-00NoNoCurrent
68462-166-156846201661528 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK28 carton2022-09-280000-00-00NoNoCurrent
68462-166-306846201663030 CAPSULE in 1 BOTTLE (68462-166-30) 30 capsule2022-09-280000-00-00NoNoCurrent
68462-166-416846201664114 in 1 CARTONHistorical