Dextroamphetamine Sulfate

Product NDC
52536-520
11-digit product format
525360520
Labeler code
52536
Product ID
52536-520_3777bded-3f46-0856-e063-6394a90a47b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Wilshire Pharmaceuticals, Inc.
Application
ANDA090533
Marketing category
ANDA
Marketing start
2021-08-06
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
20 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 SULFATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884385, 884386, 884684, 1535454, 1535470

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
52536-520-03Dextroamphetamine Sulfate30 in 1 BOTTLETABLET3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-520DEXTROAMPHETAMINE SULFATE TABLET [WILSHIRE PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 1 package rows20240724_6b8c97ac-c83c-4a1f-a33c-121239253abf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN6b8c97ac-c83c-4a1f-a33c-121239253abf14
884684dextroamphetamine sulfate 15 MG Oral TabletPSN6b8c97ac-c83c-4a1f-a33c-121239253abf14
1535454dextroamphetamine sulfate 20 MG Oral TabletPSN6b8c97ac-c83c-4a1f-a33c-121239253abf14
1535470dextroamphetamine sulfate 30 MG Oral TabletPSN6b8c97ac-c83c-4a1f-a33c-121239253abf14
884386dextroamphetamine sulfate 5 MG Oral TabletPSN6b8c97ac-c83c-4a1f-a33c-121239253abf14
884385dextroamphetamine sulfate 10 MG Oral TabletSCD6b8c97ac-c83c-4a1f-a33c-121239253abf14
884684dextroamphetamine sulfate 15 MG Oral TabletSCD6b8c97ac-c83c-4a1f-a33c-121239253abf14
1535454dextroamphetamine sulfate 20 MG Oral TabletSCD6b8c97ac-c83c-4a1f-a33c-121239253abf14
1535470dextroamphetamine sulfate 30 MG Oral TabletSCD6b8c97ac-c83c-4a1f-a33c-121239253abf14
884386dextroamphetamine sulfate 5 MG Oral TabletSCD6b8c97ac-c83c-4a1f-a33c-121239253abf14
1535454dextroamphetamine sulfate 20 MG Oral TabletPSNb40c9a90-7e2e-48d6-adb6-2351c0ca621d3
1535454dextroamphetamine sulfate 20 MG Oral TabletSCDb40c9a90-7e2e-48d6-adb6-2351c0ca621d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52536-520-035253605200330 TABLET in 1 BOTTLE (52536-520-03) 30 tablet2021-08-060000-00-00NoNoCurrent