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 114 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
Polyethylene Gycol 3350POLYETHYLENE GYCOL 3350Allegiant Health13851c9a-a226-481b-9db5-bc7053997df72025-03-17WarningsExact identifier
unii: G2M7P15E5P
Bestmade Natural Products BIO16 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Products3036922b-0f2c-12ff-e063-6394a90a85782025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20 Lactose FreeCALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products30394e7e-170f-7b9d-e063-6394a90afcdb2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27 Lactose FreeNAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products303b25cc-b559-3841-e063-6294a90a398b2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28 Lactose FreeCALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products303b4d92-9f75-38a5-e063-6294a90ae93d2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO4 Lactose FreeCALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Products30220aca-e052-95f3-e063-6294a90a9cea2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO5 Lactose FreeFERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Products30225814-b9d7-f16a-e063-6294a90a01942025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO6 Lactose FreeFERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Products302292bd-9c38-2638-e063-6294a90a965d2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO11 Lactose FreeFERR PHOS, KALI MUR, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products3025f91f-bc0a-691c-e063-6294a90ad1362025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO12 Lactose FreeFERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Products30262ecd-5bd9-80d0-e063-6294a90ab1db2025-03-12WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO20CALC FLUOR, CALC SULPH, KALI SULPH, NAT MUR, NAT SULPHBestmade Natural Products300d4674-5c2e-01b6-e063-6294a90acbf92025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO27NAT MUR, KALI PHOS, CALC PHOSBestmade Natural Products300e8ba5-1b16-ad40-e063-6294a90a674d2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC FLUOR, CALC PHOS, CALC SULPH, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEABestmade Natural Products300ead4c-6937-d597-e063-6394a90ad6bb2025-03-11WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO1 Lactose FreeCALC PHOS, FERR PHOS, KALI PHOS, NAT MURBestmade Natural Products3013926f-ecd2-d376-e063-6294a90a47432025-03-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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