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

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 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
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