FDA.reportPublic FDA data

Fingolimod

Product NDC
67877-476
11-digit product format
678770476
Labeler code
67877
Product ID
67877-476_d2f337fa-908a-4ae9-bcfd-59dcc4353705
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fingolimod hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208004
Marketing category
ANDA
Marketing start
2022-09-21
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
A208004-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208004-001AB

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 22:54:322026-06A208004-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208004-001AB1a50c72e98297…

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
FingolimodFINGOLIMODCivicaScript LLCe1960f9b-f739-452c-b167-245551bf36902026-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208004
application number: ANDA208004
FingolimodFINGOLIMOD HYDROCHLORIDEAscend Laboratories, LLC0f638feb-6986-41e4-8f9c-2e6b84a5bb442026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208004
application number: ANDA208004
ndc (product): 67877-476

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
0f638feb-6986-41e4-8f9c-2e6b84a5bb44Available 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
67877-476-14Fingolimod14 in 1 BLISTER PACKCAPSULE1419
67877-476-30Fingolimod30 in 1 BOTTLECAPSULE3019
67877-476-32Fingolimod7 in 1 CARTONCAPSULE719
67877-476-32Fingolimod7 in 1 BLISTER PACKCAPSULE719
67877-476-33Fingolimod10 in 1 CARTONCAPSULE1019
67877-476-33Fingolimod10 in 1 BLISTER PACKCAPSULE1019
67877-476-56Fingolimod28 in 1 BOTTLECAPSULE2819
67877-476-58Fingolimod28 in 1 CARTONCAPSULE2819

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-476-30EA - Each67877-47628218e75-3d4a-47ff-a9a5-85dce83d8e3512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-476FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) CAPSULE [ASCEND LABORATORIES, LLC]15Current NDC, Legacy NDC, 8 package rows20240822_0f638feb-6986-41e4-8f9c-2e6b84a5bb44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSN0f638feb-6986-41e4-8f9c-2e6b84a5bb4419
1012895fingolimod 0.5 MG Oral CapsuleSCD0f638feb-6986-41e4-8f9c-2e6b84a5bb4419
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSY0f638feb-6986-41e4-8f9c-2e6b84a5bb4419
1012895fingolimod 500 MCG Oral CapsuleSY0f638feb-6986-41e4-8f9c-2e6b84a5bb4419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-476-146787704761414 in 1 BLISTER PACKHistorical
67877-476-306787704763030 CAPSULE in 1 BOTTLE (67877-476-30) 30 capsule2022-09-210000-00-00NoNoCurrent
67877-476-32678770476327 BLISTER PACK in 1 CARTON (67877-476-32) / 7 CAPSULE in 1 BLISTER PACK7 blister pack2022-09-210000-00-00NoNoCurrent
67877-476-336787704763310 BLISTER PACK in 1 CARTON (67877-476-33) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2022-09-210000-00-00NoNoCurrent
67877-476-566787704765628 CAPSULE in 1 BOTTLE (67877-476-56) 28 capsule2022-09-210000-00-00NoNoCurrent
67877-476-586787704765828 BLISTER PACK in 1 CARTON (67877-476-58) / 14 CAPSULE in 1 BLISTER PACK (67877-476-14) 28 blister pack2022-09-210000-00-00NoNoCurrent