FDA.reportPublic FDA data

Aubagio

Product NDC
58468-0211
11-digit product format
584680211
Labeler code
58468
Product ID
58468-0211_fafc0928-a014-4dfc-8f46-e0d8aa6690bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
teriflunomide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genzyme Corporation
Application
NDA202992
Marketing category
NDA
Marketing start
2013-05-01
Substance
TERIFLUNOMIDE
Active strength
7 mg/1
Pharmacologic classes
Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aubagio
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERIFLUNOMIDE7 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1C058IKG3B
Rxcui1310525, 1310531, 1310533, 1310535

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
58468-0211-1Aubagio14 in 1 BLISTER PACKTABLET, FILM COATED1428
58468-0211-1Aubagio2 in 1 CARTONTABLET, FILM COATED228
58468-0211-2Aubagio5 in 1 BLISTER PACKTABLET, FILM COATED528
58468-0211-2Aubagio1 in 1 CARTONTABLET, FILM COATED128
58468-0211-3Aubagio5 in 1 BLISTER PACKTABLET, FILM COATED528
58468-0211-3Aubagio1 in 1 CARTONTABLET, FILM COATED128
58468-0211-4Aubagio30 in 1 BOTTLETABLET, FILM COATED3028
58468-0211-4Aubagio1 in 1 CARTONTABLET, FILM COATED128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0211-1EA - Each58468-02112b52abc5-5749-4049-837a-6d2ace167e8312013-02-13
58468-0211-2EA - Each58468-021189740f47-7a90-4682-a099-c35eb21cbf4012024-12-10
58468-0211-4EA - Each58468-0211240b047c-9e6f-4557-bb0f-0ce599693a1212019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
teriflunomideACTIVE INGREDIENT1C058IKG3BAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
teriflunomideACTIVE MOIETY1C058IKG3BAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
sodium starch glycolate type a cornINACTIVE INGREDIENTAG9B65PV6BAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
talcINACTIVE INGREDIENT7SEV7J4R1UAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0211AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORPORATION]27Current NDC, Legacy NDC, 8 package rows20240627_4650d12c-b9c8-4525-b07f-a2d773eca155.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310531Aubagio 14 MG Oral TabletPSN4650d12c-b9c8-4525-b07f-a2d773eca15528
1310535Aubagio 7 MG Oral TabletPSN4650d12c-b9c8-4525-b07f-a2d773eca15528
1310525teriflunomide 14 MG Oral TabletPSN4650d12c-b9c8-4525-b07f-a2d773eca15528
1310533teriflunomide 7 MG Oral TabletPSN4650d12c-b9c8-4525-b07f-a2d773eca15528
1310531teriflunomide 14 MG Oral Tablet [Aubagio]SBD4650d12c-b9c8-4525-b07f-a2d773eca15528
1310535teriflunomide 7 MG Oral Tablet [Aubagio]SBD4650d12c-b9c8-4525-b07f-a2d773eca15528
1310525teriflunomide 14 MG Oral TabletSCD4650d12c-b9c8-4525-b07f-a2d773eca15528
1310533teriflunomide 7 MG Oral TabletSCD4650d12c-b9c8-4525-b07f-a2d773eca15528
1310531Aubagio 14 MG Oral TabletSY4650d12c-b9c8-4525-b07f-a2d773eca15528
1310535Aubagio 7 MG Oral TabletSY4650d12c-b9c8-4525-b07f-a2d773eca15528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58468-0211-1584680211012 BLISTER PACK in 1 CARTON (58468-0211-1) > 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2013-05-012021-11-30NoNoCurrent
58468-0211-2584680211021 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-05-010000-00-00NoNoCurrent
58468-0211-3584680211031 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-05-010000-00-00YesNoCurrent
58468-0211-4584680211041 BOTTLE in 1 CARTON (58468-0211-4) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-03-280000-00-00NoNoCurrent