FDA.reportPublic FDA data

DEXTROAMPHETAMINE SULFATE

Product NDC
0406-8959
11-digit product format
004068959
Labeler code
0406
Product ID
0406-8959_f843d278-cec1-438f-8d54-120524010ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040436
Marketing category
ANDA
Marketing start
2002-01-29
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
0406-8959-01DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8959-01EA - Each0406-895982267a76-0761-4a1b-acf9-68fe1e71d45c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11
POVIDONESINACTIVE INGREDIENTFZ989GH94EDEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEXTROAMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8959DEXTROAMPHETAMINE SULFATE TABLET [SPECGX LLC]22Current NDC, Legacy NDC, 1 package rows20231104_e05cf690-d45a-4696-a1bf-40c9350cc084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNe05cf690-d45a-4696-a1bf-40c9350cc08425
884386dextroamphetamine sulfate 5 MG Oral TabletPSNe05cf690-d45a-4696-a1bf-40c9350cc08425
884385dextroamphetamine sulfate 10 MG Oral TabletSCDe05cf690-d45a-4696-a1bf-40c9350cc08425
884386dextroamphetamine sulfate 5 MG Oral TabletSCDe05cf690-d45a-4696-a1bf-40c9350cc08425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-8959-0100406895901100 TABLET in 1 BOTTLE (0406-8959-01) 100 tablet2002-01-290000-00-00NoNoCurrent