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 116 of 192 · 3,826 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: 451W47IQ8X
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
AustedoDEUTETRABENAZINETeva Neuroscience, Inc.7ea3c60a-45c7-44cc-afc2-d87fa53993c02025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA208082
application number: NDA216354
ndc (package): 68546-477-29
ndc (package): 68546-190-07
ndc (package): 68546-181-49
ndc (package): 68546-170-66
ndc (package): 68546-171-60
ndc (package): 68546-470-56
ndc (package): 68546-471-56
ndc (package): 68546-477-28
ndc (package): 68546-473-56
ndc (package): 68546-171-66
ndc (package): 68546-472-56
ndc (package): 68546-192-07
ndc (package): 68546-172-60
ndc (package): 68546-163-15
ndc (package): 68546-177-21
ndc (package): 68546-490-42
ndc (package): 68546-176-28
ndc (package): 68546-165-15
ndc (package): 68546-476-56
ndc (package): 68546-490-52
ndc (package): 68546-161-15
ndc (package): 68546-193-07
ndc (package): 68546-474-56
ndc (package): 68546-172-66
ndc (package): 68546-479-56
ndc (package): 68546-170-60
ndc (package): 68546-475-56
ndc (package): 68546-191-07
ndc (package): 68546-182-70
ndc (product): 68546-479
ndc (product): 68546-177
ndc (product): 68546-172
ndc (product): 68546-474
ndc (product): 68546-473
ndc (product): 68546-472
ndc (product): 68546-182
ndc (product): 68546-490
ndc (product): 68546-475
ndc (product): 68546-171
ndc (product): 68546-170
ndc (product): 68546-476
ndc (product): 68546-477
ndc (product): 68546-470
ndc (product): 68546-181
ndc (product): 68546-176
ndc (product): 68546-471
rxcui: 1876924
rxcui: 1876918
rxcui: 2683300
rxcui: 2281114
rxcui: 2686612
rxcui: 2541518
rxcui: 2630150
rxcui: 2541519
rxcui: 2686153
rxcui: 2630160
rxcui: 2683297
rxcui: 2683291
rxcui: 2630147
rxcui: 2281117
rxcui: 1876910
rxcui: 2683282
rxcui: 2630159
rxcui: 2683294
rxcui: 1876916
rxcui: 2541520
rxcui: 2683285
rxcui: 2683288
rxcui: 2686156
rxcui: 2630155
rxcui: 2281115
rxcui: 2630157
rxcui: 1876922
rxcui: 1876920
rxcui: 2630144
rxcui: 2281116
rxcui: 2630153
rxcui: 2686613
rxcui: 2683303
spl id: 69071a25-792d-4eec-a12a-1bb30c8fc881
spl set id: 7ea3c60a-45c7-44cc-afc2-d87fa53993c0
unii: P341G6W9NB
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
unii: ND2M416302
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
unii: ND2M416302
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
unii: ND2M416302
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLWalgreens78ed5594-433a-4f90-ad39-51e2a7dd2e212025-02-21WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLWalgreens9effa6c9-020d-4a2d-ad26-449d4119b6a02025-02-21WarningsExact identifier
unii: ND2M416302
Bestmade Natural Products BM188ALLIUM CEPA, AMBROSIA ARTEMISIA, GELSEMIUM, KALI BICHROME, NAT MUR, SABADILLABestmade Natural Products2e950192-e5cf-37b4-e063-6394a90a1e9a2025-02-20WarningsExact identifier
unii: 451W47IQ8X
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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