FDA.reportPublic FDA data

DEXTROAMPHETAMINE SULFATE

Product NDC
11534-189
11-digit product format
115340189
Labeler code
11534
Product ID
11534-189_2c5c3b56-a600-4196-9e40-ae80e4586527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
SUNRISE PHARMACEUTICAL, INC.
Application
ANDA210059
Marketing category
ANDA
Marketing start
2018-07-04
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROAMPHETAMINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884385, 884386

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11534-189-01DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET10011
11534-189-03DEXTROAMPHETAMINE SULFATE1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11534-189-01EA - Each11534-189067abb99-8749-4ad4-b2c3-6d0f2cc1d65612020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11534-189DEXTROAMPHETAMINE SULFATE TABLET [SUNRISE PHARMACEUTICAL, INC.]11Current NDC, Legacy NDC, 2 package rows20241205_93b3a40f-b7ac-4047-8ff5-3e34c2d75193.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN0ef920a9-c5b9-4d31-a478-ee18d22a3c5b104
884385dextroamphetamine sulfate 10 MG Oral TabletSCD0ef920a9-c5b9-4d31-a478-ee18d22a3c5b104
884385dextroamphetamine sulfate 10 MG Oral TabletPSNc706a849-9df6-43ca-9ac6-1d9ce6b8e855103
884385dextroamphetamine sulfate 10 MG Oral TabletSCDc706a849-9df6-43ca-9ac6-1d9ce6b8e855103
884385dextroamphetamine sulfate 10 MG Oral TabletPSN93b3a40f-b7ac-4047-8ff5-3e34c2d7519311
884386dextroamphetamine sulfate 5 MG Oral TabletPSN93b3a40f-b7ac-4047-8ff5-3e34c2d7519311
884385dextroamphetamine sulfate 10 MG Oral TabletSCD93b3a40f-b7ac-4047-8ff5-3e34c2d7519311
884386dextroamphetamine sulfate 5 MG Oral TabletSCD93b3a40f-b7ac-4047-8ff5-3e34c2d7519311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11534-189-0111534018901100 TABLET in 1 BOTTLE (11534-189-01) 100 tablet2018-07-040000-00-00NoNoCurrent
11534-189-03115340189031000 TABLET in 1 BOTTLE (11534-189-03) 1000 tablet2018-07-040000-00-00NoNoCurrent