FDA.reportPublic FDA data

FINGOLIMOD

Product NDC
65862-952
11-digit product format
658620952
Labeler code
65862
Product ID
65862-952_067884b9-a619-48da-a4b2-225dce025421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FINGOLIMOD
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207983
Marketing category
ANDA
Marketing start
2024-02-28
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
65862-952-07FINGOLIMOD7 in 1 BLISTER PACKCAPSULE75
65862-952-07FINGOLIMOD1 in 1 CARTONCAPSULE15
65862-952-28FINGOLIMOD7 in 1 BLISTER PACKCAPSULE75
65862-952-28FINGOLIMOD4 in 1 CARTONCAPSULE45
65862-952-30FINGOLIMOD30 in 1 BOTTLECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-952FINGOLIMOD CAPSULE [AUROBINDO PHARMA LIMITED]3Current NDC, 5 package rows20250312_d6301307-55c6-4b91-a505-ff93c865f859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSNd6301307-55c6-4b91-a505-ff93c865f8595
1012895fingolimod 0.5 MG Oral CapsuleSCDd6301307-55c6-4b91-a505-ff93c865f8595
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSYd6301307-55c6-4b91-a505-ff93c865f8595
1012895fingolimod 500 MCG Oral CapsuleSYd6301307-55c6-4b91-a505-ff93c865f8595

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65862-952-07658620952071 BLISTER PACK in 1 CARTON (65862-952-07) / 7 CAPSULE in 1 BLISTER PACK1 blister pack2024-02-28NoNoCurrent
65862-952-28658620952284 BLISTER PACK in 1 CARTON (65862-952-28) / 7 CAPSULE in 1 BLISTER PACK4 blister pack2024-02-28NoNoCurrent
65862-952-306586209523030 CAPSULE in 1 BOTTLE (65862-952-30) 30 capsule2024-02-28NoNoCurrent