FDA.reportPublic FDA data

Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate

Product NDC
0406-8894
11-digit product format
004068894
Labeler code
0406
Product ID
0406-8894_0d3fb5ba-ff79-4862-bc1d-45b8343e115b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA040440
Marketing category
ANDA
Marketing start
2003-10-07
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
7.5; 7.5; 7.5; 7.5 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

Additional Listing Data#

Finished product
Yes
Brand name base
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE ASPARTATE MONOHYDRATE7.5 mg/1
AMPHETAMINE SULFATE7.5 mg/1
DEXTROAMPHETAMINE SACCHARATE7.5 mg/1
DEXTROAMPHETAMINE SULFATE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6DPV8NK46S, JJ768O327N, O1ZPV620O4, G83415V073
Rxcui541363, 541878, 541892, 577957, 577961, 1009145

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
0406-8894-01Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate100 in 1 BOTTLETABLET10029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8894-01EA - Each0406-88946a3a3200-7c38-4dfc-ab84-0dd078c7867412014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPHETAMINE ASPARTATE MONOHYDRATEACTIVE INGREDIENTO1ZPV620O4DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
AMPHETAMINE SULFATEACTIVE INGREDIENT6DPV8NK46SDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
DEXTROAMPHETAMINE SACCHARATEACTIVE INGREDIENTG83415V073DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
AMPHETAMINEACTIVE MOIETYCK833KGX7EDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
POVIDONESINACTIVE INGREDIENTFZ989GH94EDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [MALLINCKRODT, INC.]14
AMPHETAMINE ASPARTATEACTIVE INGREDIENTH527KAP6L5DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
AMPHETAMINE SULFATEACTIVE INGREDIENT6DPV8NK46SDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
DEXTROAMPHETAMINE SACCHARATEACTIVE INGREDIENTG83415V073DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
DEXTROAMPHETAMINE SULFATEACTIVE INGREDIENTJJ768O327NDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
AMPHETAMINEACTIVE MOIETYCK833KGX7EDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
DEXTROAMPHETAMINEACTIVE MOIETYTZ47U051FIDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8894DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET [SPECGX LLC]28Current NDC, Legacy NDC, 1 package rows20231104_72ddd1c9-ddbd-4c95-acd9-003189a353a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
541878dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
1009145dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSN72ddd1c9-ddbd-4c95-acd9-003189a353a329
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
1009145amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCD72ddd1c9-ddbd-4c95-acd9-003189a353a329
541892mixed amphetamine salts 10 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
577957mixed amphetamine salts 15 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
577961mixed amphetamine salts 20 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
541363mixed amphetamine salts 30 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
541878mixed amphetamine salts 5 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
1009145mixed amphetamine salts 7.5 MG Oral TabletSY72ddd1c9-ddbd-4c95-acd9-003189a353a329
541878dextroamphetamine saccharate 1.25 MG / amphetamine aspartate 1.25 MG / dextroamphetamine sulfate 1.25 MG / amphetamine sulfate 1.25 MG Oral TabletPSNd63a086a-32e2-49e2-949e-64e4c922775a6
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNd63a086a-32e2-49e2-949e-64e4c922775a6
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSNd63a086a-32e2-49e2-949e-64e4c922775a6
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNd63a086a-32e2-49e2-949e-64e4c922775a6
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNd63a086a-32e2-49e2-949e-64e4c922775a6
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCDd63a086a-32e2-49e2-949e-64e4c922775a6
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDd63a086a-32e2-49e2-949e-64e4c922775a6
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCDd63a086a-32e2-49e2-949e-64e4c922775a6
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDd63a086a-32e2-49e2-949e-64e4c922775a6
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDd63a086a-32e2-49e2-949e-64e4c922775a6
541892mixed amphetamine salts 10 MG Oral TabletSYd63a086a-32e2-49e2-949e-64e4c922775a6
577957mixed amphetamine salts 15 MG Oral TabletSYd63a086a-32e2-49e2-949e-64e4c922775a6
577961mixed amphetamine salts 20 MG Oral TabletSYd63a086a-32e2-49e2-949e-64e4c922775a6
541363mixed amphetamine salts 30 MG Oral TabletSYd63a086a-32e2-49e2-949e-64e4c922775a6
541878mixed amphetamine salts 5 MG Oral TabletSYd63a086a-32e2-49e2-949e-64e4c922775a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-8894-0100406889401100 TABLET in 1 BOTTLE (0406-8894-01) 100 tablet2003-10-070000-00-00NoNoCurrent