FDA.reportPublic FDA data

NDC 58468-0210-01 - Aubagio

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58468-0210
Requested NDC
58468-0210-01
Package NDCs from labels
58468-0210-2, 58468-0210-1, 58468-0210-4, 58468-0210-3, 58468-0210-01
Manufacturer
Genzyme Corporation | OPELLA HEALTHCARE INTERNATIONAL SAS | Sanofi-Aventis Deutschland GmbH | Micro-Macinazione SA | AndersonBrecon Inc. | Penn Pharmaceutical Services Limited | EUROAPI FRANCE
Effective date
2026-02-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AubagioGenzyme Corporation | OPELLA HEALTHCARE INTERNATIONAL SAS | Sanofi-Aventis Deutschland GmbH | Micro-Macinazione SA | AndersonBrecon Inc. | Penn Pharmaceutical Services Limited | EUROAPI FRANCE2026-02-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0210-1Aubagio1 in 1 CARTONTABLET, FILM COATED128
58468-0210-1Aubagio5 in 1 BLISTER PACKTABLET, FILM COATED528
58468-0210-2Aubagio2 in 1 CARTONTABLET, FILM COATED228
58468-0210-2Aubagio14 in 1 BLISTER PACKTABLET, FILM COATED1428
58468-0210-3Aubagio5 in 1 BLISTER PACKTABLET, FILM COATED528
58468-0210-3Aubagio1 in 1 CARTONTABLET, FILM COATED128
58468-0210-4Aubagio30 in 1 BOTTLETABLET, FILM COATED3028
58468-0210-4Aubagio1 in 1 CARTONTABLET, FILM COATED128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0210AUBAGIO (TERIFLUNOMIDE) TABLET, FILM COATED [GENZYME CORPORATION]27Current NDC, Legacy NDC, 8 package rows20240627_4650d12c-b9c8-4525-b07f-a2d773eca155.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0210-1EA - Each58468-0210ef53e089-8dce-4255-8a37-d01690a3cfa712024-04-05
58468-0210-2EA - Each58468-02105f9664f9-c1e1-4e5d-b01f-0f3d13207b6312013-02-13
58468-0210-4EA - Each58468-02109a975ec8-1d9a-41d4-8398-34c6c924170812019-07-02

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

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 104 · 2,074 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
TeriflunomideTERIFLUNOMIDETeva Pharmaceuticals, Inc.c424959d-00c9-4e76-aba6-cc7464d8e9032026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1310533
rxcui: 1310525
unii: 1C058IKG3B
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.