FDA.reportPublic FDA data

fingolimod

Product NDC
64980-449
11-digit product format
649800449
Labeler code
64980
Product ID
64980-449_2622c15a-3781-3016-e063-6294a90a84d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod hcl
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207939
Marketing category
ANDA
Marketing start
2021-11-10
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64980-44964980-449-07DDiscontinued by firm2026-07-31
excluded packagepackage64980-44964980-449-28DDiscontinued by firm2026-07-31
excluded packagepackage64980-44964980-449-97DDiscontinued by firm2026-07-31

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
A207939-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2021-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207939-001AB

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 22:54:322026-06A207939-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2021-11-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207939-001AB1a50c72e98297…

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
fingolimodFINGOLIMOD HCLRising Pharma Holdings, Inc.99e7daf4-ea90-5e47-e053-2a95a90ac1b72024-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207939
application number: ANDA207939
ndc (product): 64980-449

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
99e7daf4-ea90-5e47-e053-2a95a90ac1b7Available 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
64980-449-03fingolimod30 in 1 BOTTLECAPSULE3017
64980-449-07fingolimod7 in 1 CARTONCAPSULE717
64980-449-28fingolimod28 in 1 CARTONCAPSULE2817
64980-449-97fingolimod7 in 1 BLISTER PACKCAPSULE717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-449-03EA - Each64980-44943d440db-3404-4a84-9fd1-bf92521e755412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-449FINGOLIMOD (FINGOLIMOD HCL) CAPSULE [RISING PHARMA HOLDINGS, INC.]17Current NDC, Legacy NDC, 4 package rows20241106_99e7daf4-ea90-5e47-e053-2a95a90ac1b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSN99e7daf4-ea90-5e47-e053-2a95a90ac1b717
1012895fingolimod 0.5 MG Oral CapsuleSCD99e7daf4-ea90-5e47-e053-2a95a90ac1b717
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSY99e7daf4-ea90-5e47-e053-2a95a90ac1b717
1012895fingolimod 500 MCG Oral CapsuleSY99e7daf4-ea90-5e47-e053-2a95a90ac1b717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-449-036498004490330 CAPSULE in 1 BOTTLE (64980-449-03) 30 capsule2023-09-040000-00-00NoNoCurrent
64980-449-07649800449077 CAPSULE in 1 CARTON (64980-449-07) 7 capsule2021-01-010000-00-00NoNoCurrent
64980-449-286498004492828 CAPSULE in 1 CARTON (64980-449-28) 28 capsule2021-01-010000-00-00NoNoCurrent
64980-449-97649800449977 CAPSULE in 1 BLISTER PACK (64980-449-97) 7 capsule2021-01-010000-00-00NoNoCurrent