FDA.reportPublic FDA data

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate

Product NDC
42858-725
11-digit product format
428580725
Labeler code
42858
Product ID
42858-725_124f93d9-2c76-480c-82f5-43a6d9fdb87b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals LLC
Application
ANDA213111
Marketing category
ANDA
Marketing start
2021-09-09
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
3.75; 3.75; 3.75; 3.75 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE ASPARTATE MONOHYDRATE3.75 mg/1
AMPHETAMINE SULFATE3.75 mg/1
DEXTROAMPHETAMINE SACCHARATE3.75 mg/1
DEXTROAMPHETAMINE SULFATE3.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N, G83415V073, O1ZPV620O4, 6DPV8NK46S
Rxcui541363, 541878, 541892, 577957, 577961, 687043, 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
42858-725-01Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-725-01EA - Each42858-7257d15d0da-2df3-45a7-81ab-f5e30040755012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-725DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLET [RHODES PHARMACEUTICALS L.P.]7Current NDC, Legacy NDC, 1 package rows20231031_ef3590cc-49ae-44f7-85a9-7c11f58d467e.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 TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
1009145dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
687043dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNef3590cc-49ae-44f7-85a9-7c11f58d467e9
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
1009145amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
687043amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDef3590cc-49ae-44f7-85a9-7c11f58d467e9
541892mixed amphetamine salts 10 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
687043mixed amphetamine salts 12.5 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
577957mixed amphetamine salts 15 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
577961mixed amphetamine salts 20 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
541363mixed amphetamine salts 30 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
541878mixed amphetamine salts 5 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9
1009145mixed amphetamine salts 7.5 MG Oral TabletSYef3590cc-49ae-44f7-85a9-7c11f58d467e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-725-0142858072501100 TABLET in 1 BOTTLE (42858-725-01) 100 tablet2021-09-090000-00-00NoNoCurrent