FDA.reportPublic FDA data

Adderall

Product NDC
57844-105
11-digit product format
578440105
Labeler code
57844
Product ID
57844-105_79af1dc6-c7cf-41b1-a750-e9b47c2187ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040422
Marketing category
ANDA
Marketing start
2014-11-13
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21Product name720250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2bProduct name220250616
8b92ab59-8b26-4c89-a2d6-8d5140526ec6Product name320231213
b4c312b9-fad5-247e-cef9-87a74220463dProduct name520230426
8170729e-5ba4-46f9-830f-5f0fae5942ceProduct name120230103
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27Product name520190913
b4c312b9-fad5-247e-cef9-87a74220463dProduct name420171211
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224
ffdf7f68-0f44-4dd6-a026-336dcb345fc4Product name120151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57844-105-01Adderall100 in 1 BOTTLETABLET10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57844-105-01EA - Each57844-10542e8475f-754f-49ee-b55b-c84007a46da312014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPHETAMINE ASPARTATE MONOHYDRATEACTIVE INGREDIENTO1ZPV620O4ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
AMPHETAMINE SULFATEACTIVE INGREDIENT6DPV8NK46SADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
DEXTROAMPHETAMINE SACCHARATEACTIVE INGREDIENTG83415V073ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
AMPHETAMINEACTIVE MOIETYCK833KGX7EADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5
SUCROSEINACTIVE INGREDIENTC151H8M554ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA SELECT BRANDS]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57844-105ADDERALL (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 1 package rows20240618_f22635fe-821d-4cde-aa12-419f8b53db81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
541894Adderall 10 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
687045Adderall 12.5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
577960Adderall 15 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
577962Adderall 20 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541365Adderall 30 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541879Adderall 5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
1009147Adderall 7.5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541878dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
1009145dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
687043dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNf22635fe-821d-4cde-aa12-419f8b53db8121
541879amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
1009147amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
541894amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
687045amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
577960amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
577962amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
541365amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral Tablet [Adderall]SBDf22635fe-821d-4cde-aa12-419f8b53db8121
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
1009145amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
687043amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDf22635fe-821d-4cde-aa12-419f8b53db8121
541894Adderall 10 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
687045Adderall 12.5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
577960Adderall 15 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
577962Adderall 20 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
541365Adderall 30 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
541879Adderall 5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
1009147Adderall 7.5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
541892mixed amphetamine salts 10 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
687043mixed amphetamine salts 12.5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
577957mixed amphetamine salts 15 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
577961mixed amphetamine salts 20 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
541363mixed amphetamine salts 30 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
541878mixed amphetamine salts 5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121
1009145mixed amphetamine salts 7.5 MG Oral TabletSYf22635fe-821d-4cde-aa12-419f8b53db8121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57844-105-0157844010501100 TABLET in 1 BOTTLE (57844-105-01) 100 tablet2014-11-130000-00-00NoNoCurrent