Home NDC 68546-165 NDC 68546-165 - 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 68546-165
Package NDCs from labels 68546-165-15
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 Label Manufacturer Effective date Type Austedo - Teva Neuroscience, Inc. Teva Neuroscience, Inc. 2025-02-28 HUMAN PRESCRIPTION DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68546-165-15 AUSTEDO XR 14 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 14 24 mg 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68546-165 AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.] 35 Unmatched 20250322_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 167 of 187 · 3,724 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alcohol Preps Sterile ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 65c8f4de-6516-4caa-a458-228b7b4f6f78 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd c13af96e-f76a-4577-8d57-811ccc652738 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad 70 Isopropyl Alcohol ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd af84e47f-01d6-d24e-e053-2a95a90a7edd 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad Non-Sterile ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 9b835128-194a-4527-abd5-c507ca94b197 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad Sterile ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd a4d1f759-7f35-d277-e053-2a95a90abc8c 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Swabstick ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd b576911b-bbf2-4ce7-a94a-29bbf719f205 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Swabsticks 1s Sterile ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd f725587c-ed7b-48de-885a-ac464e72e6d2 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Swabsticks 3s Sterile ISOPROPYL ALCOHOL Jianerkang Medical Co., Ltd 6b21e472-d473-4b22-bc31-78b00c523e2d 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad Medium Pad ISOPROPYL ALCOHOL Henry Schein Inc. bdd02ae1-782a-dc72-e053-2a95a90a7554 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad Medium Pad ISOPROPYL ALCOHOL Henry Schein Inc. b46933ab-41f5-7513-e053-2a95a90a0c69 2023-10-23 Warnings Exact identifier unii: ND2M416302 Alcohol Prep Pad Large Pad ISOPROPYL ALCOHOL Henry Schein Inc. b468eefd-625b-5c27-e053-2995a90ab0f4 2023-10-23 Warnings Exact identifier unii: ND2M416302 Farmasi CC Cream LIGHT to MEDIUM 02 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 28b3fdff-1986-4048-9ed5-a3d784a4014e 2023-10-23 Warnings Exact identifier unii: 15FIX9V2JP Farmasi CC Cream- MEDIUM 03 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 65de3c45-8ec2-4d73-8a29-6203d3b47bd7 2023-10-23 Warnings Exact identifier unii: 15FIX9V2JP Farmasi BB Cream- MEDIUM 03 TITANIUM DIOXIDE TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 9102aa2f-0308-4985-b8a8-8e105047b61f 2023-10-23 Warnings Exact identifier unii: 15FIX9V2JP Natrum muriaticum SODIUM CHLORIDE Boiron 8644ffef-f0ec-5c06-e053-2a91aa0ae83d 2023-10-23 Exact identifier unii: 451W47IQ8X Artistry Exact Fit Longwearing Foundation Shade Golden L4N1 TITANIUM DIOXIDE Amway Corp 7494fe09-40e0-4152-9974-a6e8a4d7f421 2023-10-22 Warnings Exact identifier unii: 15FIX9V2JP Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1 TITANIUM DIOXIDE Amway Corp cec51b88-a6b8-4b64-b3aa-830e712a3c8a 2023-10-22 Warnings Exact identifier unii: 15FIX9V2JP Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1 TITANIUM DIOXIDE Amway Corp 706e1504-fad7-44fa-9030-f5b948e3e79b 2023-10-22 Warnings Exact identifier unii: 15FIX9V2JP Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1 TITANIUM DIOXIDE Amway Corp b785af89-1134-4fc6-8388-c47c52d153e0 2023-10-22 Warnings Exact identifier unii: 15FIX9V2JP Artistry Exact Fit Longwearing Foundation Shade Natural L2N2 TITANIUM DIOXIDE Amway Corp db24e10a-6957-4ce7-8b03-572caacc647a 2023-10-22 Warnings Exact identifier unii: 15FIX9V2JP
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.