NDC 68546-193 - Austedo

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
68546-193
Package NDCs from labels
68546-193-07
Manufacturer
Teva Neuroscience, Inc.
Effective date
2025-02-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Austedo - Teva Neuroscience, Inc.Teva Neuroscience, Inc.2025-02-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68546-193-07AUSTEDO XR7 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE730 mg35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-193AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]35Unmatched20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.zip

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 149 of 187 · 3,724 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP
GriefCIMICIFUGA RACEMOSA, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, SEPIA, CEREBRUM SUIS, IGNATIA AMARA, NATRUM MURIATICUM, AMBRA GRISEA, DNA, AURUM METALLICUM, COCCULUS INDICUS, DIGITALIS PURPUREA, HELLEBORUS NIGER, LYCOPODIUM CLAVATUM, STAPHYSAGRIADeseret Biologicals, Inc.e7ff1297-512e-4e95-a918-1c57fa3a50dd2024-03-25WarningsExact identifier
unii: 451W47IQ8X
I.V. Prep Antiseptic WipeISOPROPYL ALCOHOLSmith & Nephew, Medical Ltd50f1c74a-bb8e-41c2-a7ee-f2d310a372a72024-03-21WarningsExact identifier
unii: ND2M416302
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
unii: 15FIX9V2JP
Polyvinyl AlcoholPOLYVINYL ALCOHOLA-S Medication Solutionsc77589fd-f68d-48b7-bd12-51f6b4cc94022024-03-20WarningsExact identifier
unii: 532B59J990
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
unii: 15FIX9V2JP
Bladder Kidney Meridian OpenerAPIS MELLIFICA, ARGENTUM NITRICUM, BERBERIS VULGARIS, CANTHARIS, EQUISETUM ARVENSE, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, RHUS TOX, SEPIA, TEREBINTHINA, THUJA OCCIDENTALISDeseret Biologicals, Inc.08e96657-9b15-41e3-88e5-8915cefb43be2024-03-15WarningsExact identifier
unii: 451W47IQ8X
BreatheARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)Deseret Biologicals, Inc8dbdd623-a486-4cf8-acdb-ad051dc743482024-03-15WarningsExact identifier
unii: 451W47IQ8X
Isopropyl AlcoholISOPROPYL ALCOHOLProvision Medicalad045374-f4ad-4003-b350-8a2b0cbccb2e2024-03-14WarningsExact identifier
unii: ND2M416302
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
unii: 15FIX9V2JP
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
unii: 15FIX9V2JP
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
unii: 15FIX9V2JP
smoothlaxPOLYETHYLENE GLYCOL 3350Walgreen Companyaeb5c32c-443e-4ea3-8e96-fed38225fdf32024-03-12WarningsExact identifier
unii: G2M7P15E5P
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
unii: 15FIX9V2JP
BB Noir 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs136a7f66-844c-b16a-e063-6294a90aa9752024-03-11WarningsExact identifier
unii: 15FIX9V2JP
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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