FDA.reportPublic FDA data

Fingolimod

Product NDC
68382-912
11-digit product format
683820912
Labeler code
68382
Product ID
68382-912_37d21196-e2e4-45ce-a16c-f8e8693c94de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207994
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
A207994-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207994-001AB

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 22:54:322026-06A207994-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207994-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FingolimodFINGOLIMODZydus Pharmaceuticals USA Inc.e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b32025-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207994
application number: ANDA207994
ndc (product): 68382-912
FingolimodFINGOLIMODZydus Lifesciences Limited5a0319b4-4bc6-4564-9687-9cfd5c1b23a82024-11-30Exact identifier
application applno (ANDA): 207994
application number: ANDA207994

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
e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3Available 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
68382-912-01Fingolimod100 in 1 BOTTLECAPSULE1008
68382-912-06Fingolimod30 in 1 BOTTLECAPSULE308
68382-912-16Fingolimod90 in 1 BOTTLECAPSULE908
68382-912-69Fingolimod7 in 1 BLISTER PACKCAPSULE78
68382-912-69Fingolimod1 in 1 CARTONCAPSULE18
68382-912-70Fingolimod4 in 1 CARTONCAPSULE48
68382-912-70Fingolimod7 in 1 BLISTER PACKCAPSULE78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-912-06EA - Each68382-912939a6b69-9edb-4fa6-8b52-edda4509149512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-912FINGOLIMOD CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 7 package rows20250426_e738dbd9-f4cc-49a0-98ce-73dd0c3ff3b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSNe738dbd9-f4cc-49a0-98ce-73dd0c3ff3b38
1012895fingolimod 0.5 MG Oral CapsuleSCDe738dbd9-f4cc-49a0-98ce-73dd0c3ff3b38
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSYe738dbd9-f4cc-49a0-98ce-73dd0c3ff3b38
1012895fingolimod 500 MCG Oral CapsuleSYe738dbd9-f4cc-49a0-98ce-73dd0c3ff3b38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-912-0168382091201100 CAPSULE in 1 BOTTLE (68382-912-01) 100 capsule2022-10-110000-00-00NoNoCurrent
68382-912-066838209120630 CAPSULE in 1 BOTTLE (68382-912-06) 30 capsule2022-10-110000-00-00NoNoCurrent
68382-912-166838209121690 CAPSULE in 1 BOTTLE (68382-912-16) 90 capsule2022-10-110000-00-00NoNoCurrent
68382-912-69683820912691 BLISTER PACK in 1 CARTON (68382-912-69) / 7 CAPSULE in 1 BLISTER PACK1 blister pack2022-10-110000-00-00NoNoCurrent
68382-912-70683820912704 BLISTER PACK in 1 CARTON (68382-912-70) / 7 CAPSULE in 1 BLISTER PACK4 blister pack2022-10-110000-00-00NoNoCurrent