FDA.reportPublic FDA data

NDC 68546-192 - 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
68546-192
Package NDCs from labels
68546-192-07
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
68546-192-07AUSTEDO XR7 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE724 mg35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-192AUSTEDO (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 85 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Woro Beauty SPFortlessTITANIUM DIOXIDE, ZINC OXIDEWoro Beauty3d86ef02-c947-2791-e063-6394a90a42cc2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d506dd-4103-de3c-e063-6294a90ac1902025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5174f-6bd2-1294-e063-6294a90a407b2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5299f-6273-30ab-e063-6294a90a082e2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
unii: 15FIX9V2JP
BRING GREEN TEA TREE CICA SUN CUSHIONZINC OXIDE, TITANIUM DIOXIDECJ Olive Young Corporation30850a56-6438-dbe1-e063-6294a90a6d9f2025-11-17WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
unii: 15FIX9V2JP
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
unii: ND2M416302
Huey Daily MineralTITANIUM DIOXIDE, ZINC OXIDEHuey15bdf9c6-3bfa-4eef-e063-6294a90a195f2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
unii: 15FIX9V2JP
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
unii: 15FIX9V2JP
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
BodyMed Alcohol Prep PadALCOHOL PREP PADBoxout, LLCd30dce9c-8d12-4c71-e053-2995a90a12052025-11-14WarningsExact identifier
unii: ND2M416302
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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