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

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
A208000-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2021-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208000-001AB

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 22:54:322026-06A208000-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2021-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208000-001AB1a50c72e98297…

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
FingolimodFINGOLIMODDr. Reddy's Laboratories Inc56badc2a-6747-9284-300e-bf072eb072ed2025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208000
application number: ANDA208000
ndc (product): 43598-285

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
56badc2a-6747-9284-300e-bf072eb072edAvailable 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
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