Home NDC 68546-193 NDC 68546-193 - 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 68546-193
Package NDCs from labels 68546-193-07
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 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 68546-193-07 AUSTEDO XR 7 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 7 30 mg 35
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68546-193 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