FDA.reportPublic FDA data

FINGOLIMOD HYDROCHLORIDE

Product NDC
16729-342
11-digit product format
167290342
Labeler code
16729
Product ID
16729-342_4148bb57-7d2c-1724-e063-6294a90a34fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FINGOLIMOD HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA207991
Marketing category
ANDA
Marketing start
2022-10-18
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
A207991-001FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207991-001AB

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 22:54:322026-06A207991-001FINGOLIMOD HYDROCHLORIDEEQ 0.5MG BASECAPSULE / ORALAB2020-10-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207991-001AB1a50c72e98297…

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
FINGOLIMOD HYDROCHLORIDEFINGOLIMOD HYDROCHLORIDEAccord Healthcare Inc.65e59a51-c9c2-47b4-84fc-e0f8879eb26c2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207991
application number: ANDA207991
ndc (product): 16729-342

Additional Listing Data#

Finished product
Yes
Brand name base
FINGOLIMOD HYDROCHLORIDE
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
65e59a51-c9c2-47b4-84fc-e0f8879eb26cAvailable 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
16729-342-10FINGOLIMOD HYDROCHLORIDE30 in 1 BOTTLECAPSULE305
16729-342-15FINGOLIMOD HYDROCHLORIDE90 in 1 BOTTLECAPSULE905
16729-342-17FINGOLIMOD HYDROCHLORIDE1000 in 1 BOTTLECAPSULE10005
16729-342-87FINGOLIMOD HYDROCHLORIDE7 in 1 CARTONCAPSULE75
16729-342-88FINGOLIMOD HYDROCHLORIDE28 in 1 CARTONCAPSULE285
16729-342-89FINGOLIMOD HYDROCHLORIDE7 in 1 BOTTLECAPSULE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-342-10EA - Each16729-3429a43d677-f657-4ce6-9864-81bd8629d92412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-342FINGOLIMOD HYDROCHLORIDE CAPSULE [ACCORD HEALTHCARE INC.]4Current NDC, Legacy NDC, 6 package rows20240221_65e59a51-c9c2-47b4-84fc-e0f8879eb26c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012895fingolimod 0.5 MG Oral CapsulePSN65e59a51-c9c2-47b4-84fc-e0f8879eb26c5
1012895fingolimod 0.5 MG Oral CapsuleSCD65e59a51-c9c2-47b4-84fc-e0f8879eb26c5
1012895fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral CapsuleSY65e59a51-c9c2-47b4-84fc-e0f8879eb26c5
1012895fingolimod 500 MCG Oral CapsuleSY65e59a51-c9c2-47b4-84fc-e0f8879eb26c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-342-101672903421030 CAPSULE in 1 BOTTLE (16729-342-10) 30 capsule2022-10-180000-00-00NoNoCurrent
16729-342-151672903421590 in 1 BOTTLEHistorical
16729-342-17167290342171000 in 1 BOTTLEHistorical
16729-342-87167290342877 in 1 CARTONHistorical
16729-342-881672903428828 in 1 CARTONHistorical
16729-342-89167290342897 in 1 BOTTLEHistorical