FDA.reportPublic FDA data

DEXTROAMPHETAMINE SULFATE

Product NDC
13107-035
11-digit product format
131070035
Labeler code
13107
Product ID
13107-035_a0c002da-f6e9-4979-af9b-5ca20118bc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROAMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA202893
Marketing category
ANDA
Marketing start
2013-07-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-035-012024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII
13107-035-502024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII
13107-035-992024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-035-01DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET10013
13107-035-50DEXTROAMPHETAMINE SULFATE50 in 1 BOTTLETABLET5013
13107-035-99DEXTROAMPHETAMINE SULFATE1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-035-01EA - Each13107-0359425cacf-2086-4649-a3cc-a369b8cf19dc12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-035DEXTROAMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC]13Current NDC, Legacy NDC, 3 package rows20240702_24163442-dd03-4066-a6ed-eb7e292b700b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN24163442-dd03-4066-a6ed-eb7e292b700b13
884386dextroamphetamine sulfate 5 MG Oral TabletPSN24163442-dd03-4066-a6ed-eb7e292b700b13
884385dextroamphetamine sulfate 10 MG Oral TabletSCD24163442-dd03-4066-a6ed-eb7e292b700b13
884386dextroamphetamine sulfate 5 MG Oral TabletSCD24163442-dd03-4066-a6ed-eb7e292b700b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-035-0113107003501100 TABLET in 1 BOTTLE (13107-035-01) 100 tablet2013-07-310000-00-00NoNoCurrent
13107-035-501310700355050 TABLET in 1 BOTTLE (13107-035-50) 50 tablet2013-07-310000-00-00NoNoCurrent
13107-035-99131070035991000 TABLET in 1 BOTTLE (13107-035-99) 1000 tablet2013-07-310000-00-00NoNoCurrent