FDA.reportPublic FDA data

AUSTEDO XR

Product NDC
68546-476
11-digit product format
685460476
Labeler code
68546
Product ID
68546-476_69071a25-792d-4eec-a12a-1bb30c8fc881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deutetrabenazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Neuroscience, Inc.
Application
NDA216354
Marketing category
NDA
Marketing start
2024-05-29
Substance
DEUTETRABENAZINE
Active strength
48 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AUSTEDO XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEUTETRABENAZINE48 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP341G6W9NB
Rxcui1876910, 1876916, 1876918, 1876920, 1876922, 1876924, 2281114, 2281115, 2281116, 2281117, 2541518, 2541519, 2541520, 2630144, 2630147, 2630150, 2630153, 2630155, 2630157, 2630159

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e68dd8a3-5582-4eab-8887-a36647084a78Product name220250224
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68546-476-56AUSTEDO XR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68546-476-56EA - Each68546-476e292ec31-6ca9-4e0b-803d-1e4ded74280212024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-476AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]35Current NDC, 1 package rows20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2630160{14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG]BPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541519{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]BPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281115{14 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 14 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose Pack]BPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281117{21 (deutetrabenazine 6 MG Oral Tablet [Austedo]) } Pack [Austedo 6 MG Starting Dose Pack]BPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686613{7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MG]BPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630159{14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541520{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541518{14 (deutetrabenazine 12 MG Oral Tablet) / 28 (deutetrabenazine 6 MG Oral Tablet) / 28 (deutetrabenazine 9 MG Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281114{14 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281116{21 (deutetrabenazine 6 MG Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686612{7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet) } PackGPCK7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281117Austedo (Chorea associated w/Huntington's disease) 6 MG Starting Dose PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876916Austedo 12 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541519Austedo 12 MG Starting Dose, 4 Week Titration PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876920Austedo 6 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876924Austedo 9 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281115Austedo Tardive Dyskinesia 12 MG Starting Dose PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630147Austedo XR 12 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686156Austedo XR 18 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630153Austedo XR 24 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683285Austedo XR 30 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683291Austedo XR 36 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683297Austedo XR 42 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683303Austedo XR 48 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630157Austedo XR 6 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686613Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MGPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630160Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MGPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630144deutetrabenazine 12 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876910deutetrabenazine 12 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686153deutetrabenazine 18 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630150deutetrabenazine 24 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683282deutetrabenazine 30 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683288deutetrabenazine 36 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683300deutetrabenazine 48 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630155deutetrabenazine 6 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876918deutetrabenazine 6 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876922deutetrabenazine 9 MG Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2686612deutetrabenazine once daily pack 12 MG (7), 18 MG (7), 24 MG (7), 30 MG (7) Extended Release Oral Tablet 4 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630159deutetrabenazine once daily pack 6 MG (14), 12 MG (14), 24 MG (14) Extended Release Oral Tablet 4 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281114deutetrabenazine starter pack 6 MG (14), 9 MG (14) Oral Tablet 2 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281116deutetrabenazine starter pack 6 MG (21) Oral Tablet 2 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541520deutetrabenazine starter pack 6 MG (21), 9 MG (14), 12 MG (14) Oral Tablet 4 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541518deutetrabenazine starter pack 6 MG (28), 9 MG (28), 12 MG (14) Oral Tablet 4 Week PackPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683294deutetrabenazine XR 42 MG 24HR Extended Release Oral TabletPSN7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263014724 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268615624 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263015324 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268328524 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268329124 HR deutetrabenazine 36 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268329724 HR deutetrabenazine 42 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268330324 HR deutetrabenazine 48 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263015724 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876916deutetrabenazine 12 MG Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876920deutetrabenazine 6 MG Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876924deutetrabenazine 9 MG Oral Tablet [Austedo]SBD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263014424 HR deutetrabenazine 12 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268615324 HR deutetrabenazine 18 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263015024 HR deutetrabenazine 24 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268328224 HR deutetrabenazine 30 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268328824 HR deutetrabenazine 36 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268329424 HR deutetrabenazine 42 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268330024 HR deutetrabenazine 48 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
263015524 HR deutetrabenazine 6 MG Extended Release Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876910deutetrabenazine 12 MG Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876918deutetrabenazine 6 MG Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876922deutetrabenazine 9 MG Oral TabletSCD7ea3c60a-45c7-44cc-afc2-d87fa53993c035
268615624 HR Austedo 18 MG Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630147Austedo 12 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876916Austedo 12 MG Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281115Austedo 12 MG Starting Dose PackSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2541519Austedo 12 MG Starting Dose, 4 Week Titration PackSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630153Austedo 24 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683285Austedo 30 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683291Austedo 36 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683297Austedo 42 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2683303Austedo 48 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2630157Austedo 6 MG 24 HR Extended Release Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876920Austedo 6 MG Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
2281117Austedo 6 MG Starting Dose PackSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035
1876924Austedo 9 MG Oral TabletSY7ea3c60a-45c7-44cc-afc2-d87fa53993c035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68546-476-566854604765630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-476-56) 2024-05-29NoNoHistorical