FDA.reportPublic FDA data

AZSTARYS

Product NDC
65038-561
11-digit product format
650380561
Labeler code
65038
Product ID
65038-561_515506d2-5c3d-92d2-e063-6394a90a0603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Serdexmethylphenidate and Dexmethylphenidate
Dosage form
CAPSULE
Route
ORAL
Labeler
Commave Sub, LLC
Application
NDA212994
Marketing category
NDA
Marketing start
2021-07-16
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE
Active strength
10.4; 52.3 mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZSTARYS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMETHYLPHENIDATE HYDROCHLORIDE10.4 mg/1
SERDEXMETHYLPHENIDATE CHLORIDE52.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFN54BT298Y, 1678OK0E08
Rxcui2562186, 2562187, 2562191, 2562194, 2562199, 2562204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1ff349b0-f325-4585-9c0d-7dc58eb1bc1bProduct name120210818
7d5b6b15-5a1e-e1e5-992d-90d0701572adProduct name920210511
ccfbb2ac-2915-4b21-1d79-8a93f773e70fProduct name920200714

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65038-561-99AZSTARYS100 in 1 BOTTLE, PLASTICCAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65038-561-99EA - Each65038-561d76ab9dc-4597-4c80-8996-6ea6718b9d0412021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65038-561AZSTARYS (SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE) CAPSULE [CORIUM, LLC.]7Current NDC, Legacy NDC, 1 package rows20231026_00b5e716-5564-4bbd-acaf-df2bc45a5663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2562199Azstarys 10.4 MG / 52.3 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562186Azstarys 5.2 MG / 26.1 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562204Azstarys 7.8 MG / 39.2 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562194dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562187dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562191dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral CapsulePSN00b5e716-5564-4bbd-acaf-df2bc45a56639
2562199dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule [Azstarys]SBD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562186dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule [Azstarys]SBD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562204dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral Capsule [Azstarys]SBD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562194dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral CapsuleSCD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562187dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral CapsuleSCD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562191dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral CapsuleSCD00b5e716-5564-4bbd-acaf-df2bc45a56639
2562199Azstarys (dexmethylphenidate 10.4 MG (as dexmethylphenidate hydrochloride 12 MG) / serdexmethylphenidate 52.3 MG (as serdexmethylphenidate chloride 56 MG)) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639
2562186Azstarys (dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG)) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639
2562204Azstarys (dexmethylphenidate 7.8 MG (as dexmethylphenidate hydrochloride 9 MG) / serdexmethylphenidate 39.2 MG (as serdexmethylphenidate chloride 42 MG)) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639
2562194dexmethylphenidate 10.4 MG (as dexmethylphenidate hydrochloride 12 MG) / serdexmethylphenidate 52.3 MG (as serdexmethylphenidate chloride 56 MG) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639
2562187dexmethylphenidate 5.2 MG (as dexmethylphenidate hydrochloride 6 MG) / serdexmethylphenidate 26.1 MG (as serdexmethylphenidate chloride 28 MG) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639
2562191dexmethylphenidate 7.8 MG (as dexmethylphenidate hydrochloride 9 MG) / serdexmethylphenidate 39.2 MG (as serdexmethylphenidate chloride 42 MG) Oral CapsuleSY00b5e716-5564-4bbd-acaf-df2bc45a56639

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65038-561-9965038056199100 CAPSULE in 1 BOTTLE, PLASTIC (65038-561-99) 100 capsule2021-07-160000-00-00NoNoCurrent