FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
43386-871
11-digit product format
433860871
Labeler code
43386
Product ID
43386-871_fe1d7b03-a5d0-4a7c-99ad-7aca6edb5d02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA204330
Marketing category
ANDA
Marketing start
2016-04-25
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
43386-871-01Dextroamphetamine Sulfate100 in 1 BOTTLETABLET1007
43386-871-03Dextroamphetamine Sulfate30 in 1 BOTTLETABLET307
43386-871-10Dextroamphetamine Sulfate1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-871-01EA - Each43386-871ab4e94f0-5165-42a4-8320-8c518286657f12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-871DEXTROAMPHETAMINE SULFATE TABLET [LUPIN PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240131_9aea6b7c-729c-484d-b625-c3591b63b350.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN9aea6b7c-729c-484d-b625-c3591b63b3507
884386dextroamphetamine sulfate 5 MG Oral TabletPSN9aea6b7c-729c-484d-b625-c3591b63b3507
884385dextroamphetamine sulfate 10 MG Oral TabletSCD9aea6b7c-729c-484d-b625-c3591b63b3507
884386dextroamphetamine sulfate 5 MG Oral TabletSCD9aea6b7c-729c-484d-b625-c3591b63b3507

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-871-0143386087101100 TABLET in 1 BOTTLE (43386-871-01) 100 tablet2016-04-250000-00-00NoNoCurrent
43386-871-034338608710330 TABLET in 1 BOTTLE (43386-871-03) 30 tablet2016-04-250000-00-00NoNoCurrent
43386-871-10433860871101000 TABLET in 1 BOTTLE (43386-871-10) 1000 tablet2016-04-250000-00-00NoNoCurrent