FDA.reportPublic FDA data

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 22 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: G2M7P15E5P
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
unii: G2M7P15E5P
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
unii: ND2M416302
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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