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
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
68546-161-15	AUSTEDO XR	14 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	14	6 mg	35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68546-161	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 188 of 188 · 3,743 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13		Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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