NDC 68546-161 - 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
68546-161
Package NDCs from labels
68546-161-15
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
68546-161-15AUSTEDO XR14 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE146 mg35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-161AUSTEDO (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 143 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CV HPADONIS VERNALIS, LACHESIS MUTUS, LYCOPUS VIRGINICUS, VALERIANA OFFICINALIS, AURUM METALLICUM, CACTUS GRANDIFLORUS, DIGITALIS PURPUREA, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS),ENERGIQUE, INC.c06763c5-8bde-4251-bd41-67becf8ce8c42024-10-24WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.2af0dc7b-5f8b-44fa-9589-bc95043428e92024-10-24WarningsExact identifier
unii: 451W47IQ8X
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
unii: 15FIX9V2JP
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
unii: 15FIX9V2JP
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: 451W47IQ8X
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
unii: 15FIX9V2JP
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.a631a250-d6d8-479c-a53e-347ac908c5ff2024-10-22WarningsExact identifier
unii: 451W47IQ8X
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 451W47IQ8X
Isopropyl Rubbing Alcohol 99%ISOPROPYL ALCOHOLUniversal Distribution Center LLC678a9b14-2838-4358-9673-fc23e0f58efb2024-10-21WarningsExact identifier
unii: ND2M416302
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLCa9960d2f-f13a-4168-b2e9-d6f4a35d84ae2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLUniversal Distribution Center LLC5db1659e-3a13-47f0-90ae-f8f192c6111a2024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC3dcdc1cc-ece8-4b47-a236-ee57c375bb992024-10-21WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 50% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC0b185535-b1af-4128-89ca-65b0e63cd4302024-10-21WarningsExact identifier
unii: ND2M416302
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f4481bf3-6dc7-5641-e053-2a95a90ad9382024-10-18WarningsExact identifier
unii: 15FIX9V2JP
Fruit of the Earth Sun Town City Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f45d25d2-9305-5858-e053-2a95a90a7f7b2024-10-18WarningsExact identifier
unii: 15FIX9V2JP
RhustoxoforceAPIS MELLIFICA, CANTHARIS, GRAPHITES, NATRUM MURIATICUM, RHUS GLABRA, RHUS TOXICODENDRON, RHUS VENENATA, URTICA DIOICABioActive Nutritional, Inc.5a3627f1-a850-42f3-8c7a-b2067bd035382024-10-18WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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