FDA.reportPublic FDA data

FINGOLIMOD

Product NDC
64380-776
Requested package NDC
64380-776-26
11-digit product format
643800776
Labeler code
64380
Product ID
64380-776_5404ed8d-1fee-4b0c-b5f9-e63a61675e43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fingolimod
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA207971
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
0000-00-00
Substance
FINGOLIMOD HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64380-77664380-776-26DDiscontinued by firm2026-08-03

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
A207971-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-06-29

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 22:54:322026-06A207971-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORAL2020-06-29a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-776-042024-03-11C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
64380-776-262024-03-11C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
64380-776-272024-03-11C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
64380-776-042024-01-30C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
64380-776-262024-01-30C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010
64380-776-272024-01-30C16284748780-11030e365-5ec5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FINGOLIMOD CAPSULES safely and effectively. See full prescribing information for FINGOLIMOD CAPSULES. FINGOLIMOD capsules, for oral use Initial U.S. Approval: 2010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-776-26643800776261 BLISTER PACK in 1 CARTON (64380-776-26) > 7 CAPSULE in 1 BLISTER PACK (64380-776-00) 1 blister pack2022-11-150000-00-00NoNoCurrent