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

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
A207983-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2024-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207983-001AB

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 22:54:322026-06A207983-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2024-02-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207983-001AB1a50c72e98297…

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
FINGOLIMODFINGOLIMODAurobindo Pharma Limitedd6301307-55c6-4b91-a505-ff93c865f8592026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207983
application number: ANDA207983
ndc (product): 65862-952

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 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
d6301307-55c6-4b91-a505-ff93c865f859Available 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-952-30EA - Each65862-952b4b6556b-9e58-4392-8431-5312a8fd803612024-06-10

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