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 180 of 188 · 3,743 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	fd9689a4-21d1-49f0-bf59-b8e1da72cd16	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c23b6a87-8cf9-4be3-8306-2285e7e926c1	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	a93cb6c6-d7c2-43cc-a2e8-961f896a977e	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	32d99955-1593-426b-958e-5dcf689192a3	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	762deb57-754b-46a9-9907-de05e11da178	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3b5366e4-180a-4b98-9524-63601ae9d270	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3e67abb5-84a4-4a78-9ea3-9fd57cbeb482	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	477d79c1-f169-4d0e-a95d-f5e832855f0d	2021-11-04	Warnings	Exact identifier unii: 15FIX9V2JP
Adrenal and DHEA	ARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.	ProBLEN	44991952-c440-4a33-9423-a9369c8bab70	2021-10-22	Warnings	Exact identifier unii: 451W47IQ8X
Dr. Talbots Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC.	91c2795d-4cde-6e2c-e053-2995a90a0096	2021-10-05	Warnings	Exact identifier unii: 451W47IQ8X
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Polyethylene Glycol	POLYETHYLENE GLYCOL	BluePoint Laboratories	c4cae70c-68da-0bbc-e053-2a95a90a395a	2021-09-20	Warnings	Exact identifier unii: G2M7P15E5P
NATRUM MURIATICUM	NATRUM MURIATICUM	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	520edb18-5f2a-4448-ba53-83408a839e1f	2021-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Lactated Ringers Irrigation	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	B. Braun Medical Inc.	0db56c7a-2b8f-4593-8591-2c481c92b2cf	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride for Irrigation	SODIUM CHLORIDE FOR IRRIGATION	B. Braun Medical Inc.	5bd9b176-0402-4a3f-a6b4-c3f393fc092a	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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