FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
10702-065
11-digit product format
107020065
Labeler code
10702
Product ID
10702-065_0f296f50-a802-d586-e063-6394a90a4888
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA203548
Marketing category
ANDA
Marketing start
2015-11-23
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
5 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 SULFATE5 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
10702-065-01Dextroamphetamine Sulfate100 in 1 BOTTLETABLET10014
10702-065-03Dextroamphetamine Sulfate30 in 1 BOTTLETABLET3014
10702-065-06Dextroamphetamine Sulfate60 in 1 BOTTLETABLET6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-065-01EA - Each10702-06513b3de71-a9d5-4aca-b15f-0b59c01d3a4112016-01-13
10702-065-03EA - Each10702-065751cd023-e885-4ff6-bcf1-63e8013664e212016-01-13
10702-065-06EA - Each10702-06508cac5b1-c214-44cd-90b4-be8f2209bd5a12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-065DEXTROAMPHETAMINE SULFATE TABLET [KVK-TECH, INC.]14Current NDC, Legacy NDC, 3 package rows20240119_863d66fe-9c38-463a-afa1-552647494c5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN863d66fe-9c38-463a-afa1-552647494c5a14
884386dextroamphetamine sulfate 5 MG Oral TabletPSN863d66fe-9c38-463a-afa1-552647494c5a14
884385dextroamphetamine sulfate 10 MG Oral TabletSCD863d66fe-9c38-463a-afa1-552647494c5a14
884386dextroamphetamine sulfate 5 MG Oral TabletSCD863d66fe-9c38-463a-afa1-552647494c5a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-065-0110702006501100 TABLET in 1 BOTTLE (10702-065-01) 100 tablet2015-11-230000-00-00NoNoCurrent
10702-065-031070200650330 TABLET in 1 BOTTLE (10702-065-03) 30 tablet2015-11-230000-00-00NoNoCurrent
10702-065-061070200650660 TABLET in 1 BOTTLE (10702-065-06) 60 tablet2015-11-230000-00-00NoNoCurrent