FDA.reportPublic FDA data

Fingolimod

Product NDC
43598-285
11-digit product format
435980285
Labeler code
43598
Product ID
43598-285_1d9a673c-7eb0-b5c3-eb90-9abce3ef9141
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA208000
Marketing category
ANDA
Marketing start
2022-10-11
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
43598-285-30Fingolimod30 in 1 BOTTLECAPSULE3013
43598-285-31Fingolimod3 in 1 CARTONCAPSULE313
43598-285-70Fingolimod1 in 1 CARTONCAPSULE113
43598-285-70Fingolimod7 in 1 BLISTER PACKCAPSULE713
43598-285-79Fingolimod10 in 1 BLISTER PACKCAPSULE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-285-30EA - Each43598-285a7b7d781-2028-4d96-9776-5d744fbd020312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-285FINGOLIMOD CAPSULE [DR. REDDY'S LABORATORIES INC]12Current NDC, Legacy NDC, 5 package rows20240807_56badc2a-6747-9284-300e-bf072eb072ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSN56badc2a-6747-9284-300e-bf072eb072ed13
1012895fingolimod 0.5 MG Oral CapsuleSCD56badc2a-6747-9284-300e-bf072eb072ed13
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSY56badc2a-6747-9284-300e-bf072eb072ed13
1012895fingolimod 500 MCG Oral CapsuleSY56badc2a-6747-9284-300e-bf072eb072ed13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-285-304359802853030 CAPSULE in 1 BOTTLE (43598-285-30) 30 capsule2022-10-110000-00-00NoNoCurrent
43598-285-31435980285313 BLISTER PACK in 1 CARTON (43598-285-31) / 10 CAPSULE in 1 BLISTER PACK (43598-285-79) 3 blister pack2022-10-110000-00-00NoNoCurrent
43598-285-70435980285701 BLISTER PACK in 1 CARTON (43598-285-70) / 7 CAPSULE in 1 BLISTER PACK1 blister pack2022-10-110000-00-00NoNoCurrent
43598-285-794359802857910 in 1 BLISTER PACKHistorical