FDA.reportPublic FDA data

DEXTROAMPHETAMINE SULFATE

Product NDC
13107-036
11-digit product format
131070036
Labeler code
13107
Product ID
13107-036_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202893-001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2013-07-31
A202893-002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2013-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202893-001AA
A202893-002AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202893-001DEXTROAMPHETAMINE SULFATE5MGTABLET / ORALAA2013-07-31a50c72e98297…
2026-08-01 22:54:322026-06A202893-002DEXTROAMPHETAMINE SULFATE10MGTABLET / ORALAA2013-07-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202893-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A202893-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATEAurolife Pharma, LLC24163442-dd03-4066-a6ed-eb7e292b700b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202893
application number: ANDA202893
ndc (product): 13107-036

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JJ768O327NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884385Internal RxNorm lookup
884386Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
24163442-dd03-4066-a6ed-eb7e292b700bAvailable on FDA.report

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
13107-036-012024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII
13107-036-502024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII
13107-036-992024-01-31C16284748780-11030e365-11eb-111a-e063-dadaa90a10e2Dextroamphetamine Sulfate Tablets, USP CII

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-036-01DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET10013
13107-036-50DEXTROAMPHETAMINE SULFATE50 in 1 BOTTLETABLET5013
13107-036-99DEXTROAMPHETAMINE SULFATE1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-036-01EA - Each13107-036aa982005-e453-479a-8e50-53d753c4a53e12014-08-01

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
13107-036DEXTROAMPHETAMINE 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
13107-036-0113107003601100 TABLET in 1 BOTTLE (13107-036-01) 100 tablet2013-07-310000-00-00NoNoCurrent
13107-036-501310700365050 TABLET in 1 BOTTLE (13107-036-50) 50 tablet2013-07-310000-00-00NoNoCurrent
13107-036-99131070036991000 TABLET in 1 BOTTLE (13107-036-99) 1000 tablet2013-07-310000-00-00NoNoCurrent