FDA.reportPublic FDA data

TERIFLUNOMIDE

Product NDC
68254-5009
Requested package NDC
68254-5009-1
11-digit product format
682545009
Labeler code
68254
Product ID
68254-5009_ebb5a19c-6889-4d12-b9fd-b7dea06a52d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERIFLUNOMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CONCORD BIOTECH LIMITED
Application
ANDA218663
Marketing category
ANDA
Marketing start
2025-07-07
Substance
TERIFLUNOMIDE
Active strength
7 mg/1
Pharmacologic classes
Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68254-500968254-5009-1DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218663-001TERIFLUNOMIDETERIFLUNOMIDE7MGTABLET / ORALAB2025-04-07
A218663-002TERIFLUNOMIDETERIFLUNOMIDE14MGTABLET / ORALAB2025-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218663-001AB
A218663-002AB

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
2026-02-19 14:30 UTC2026-02A218663-001TERIFLUNOMIDE7MGTABLET / ORAL2025-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218663-002TERIFLUNOMIDE14MGTABLET / ORAL2025-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218663-001TERIFLUNOMIDE7MGTABLET / ORAL2025-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218663-002TERIFLUNOMIDE14MGTABLET / ORAL2025-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A218663-001TERIFLUNOMIDE7MGTABLET / ORALAB2025-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218663-002TERIFLUNOMIDE14MGTABLET / ORALAB2025-04-076a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218663-001TERIFLUNOMIDE7MGTABLET / ORALAB2025-04-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218663-002TERIFLUNOMIDE14MGTABLET / ORALAB2025-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A218663-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A218663-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218663-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218663-002AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b23dff57-5bec-bcbf-9b41-f1c0342e8e1eProduct name720240514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68254-5009-1TERIFLUNOMIDE30 in 1 BOTTLETABLET, FILM COATED302

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TERIFLUNOMIDETERIFLUNOMIDECONCORD BIOTECH LIMITED2d2724f6-8812-4a26-b2ec-936b71f868e12026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218663
application number: ANDA218663

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310525teriflunomide 14 MG Oral TabletPSN2d2724f6-8812-4a26-b2ec-936b71f868e12
1310533teriflunomide 7 MG Oral TabletPSN2d2724f6-8812-4a26-b2ec-936b71f868e12
1310525teriflunomide 14 MG Oral TabletSCD2d2724f6-8812-4a26-b2ec-936b71f868e12
1310533teriflunomide 7 MG Oral TabletSCD2d2724f6-8812-4a26-b2ec-936b71f868e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68254-5009-16825450090130 TABLET, FILM COATED in 1 BOTTLE (68254-5009-1) 2025-07-07NoNoHistorical