Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII

Product NDC
47781-175
11-digit product format
477810175
Labeler code
47781
Product ID
47781-175_87ce58dd-649e-b0f1-a974-2dfe8cb7a2f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 mg,Cll
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA207388
Marketing category
ANDA
Marketing start
2017-07-28
Marketing end
0000-00-00
Substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Active strength
2 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
47781-175-01Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII100 in 1 BOTTLETABLET10015
47781-175-05Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII500 in 1 BOTTLETABLET50015
47781-175-30Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII30 in 1 BOTTLETABLET3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-175DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 7.5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 10 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS,CII (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, 12.5 MG,CLL) TABLET DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMP15Legacy NDC, 3 package rows20250507_c907301d-e24d-9609-5529-fed14f94549f.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 TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
1009145dextroamphetamine saccharate 1.875 MG / amphetamine aspartate 1.875 MG / dextroamphetamine sulfate 1.875 MG / amphetamine sulfate 1.875 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
541892dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
687043dextroamphetamine saccharate 3.125 MG / amphetamine aspartate 3.125 MG / dextroamphetamine sulfate 3.125 MG / amphetamine sulfate 3.125 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
577957dextroamphetamine saccharate 3.75 MG / amphetamine aspartate 3.75 MG / dextroamphetamine sulfate 3.75 MG / amphetamine sulfate 3.75 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
577961dextroamphetamine saccharate 5 MG / amphetamine aspartate 5 MG / dextroamphetamine sulfate 5 MG / amphetamine sulfate 5 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
541363dextroamphetamine saccharate 7.5 MG / amphetamine aspartate 7.5 MG / dextroamphetamine sulfate 7.5 MG / amphetamine sulfate 7.5 MG Oral TabletPSNc907301d-e24d-9609-5529-fed14f94549f15
541878amphetamine aspartate 1.25 MG / amphetamine sulfate 1.25 MG / dextroamphetamine saccharate 1.25 MG / dextroamphetamine sulfate 1.25 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
1009145amphetamine aspartate 1.875 MG / amphetamine sulfate 1.875 MG / dextroamphetamine saccharate 1.875 MG / dextroamphetamine sulfate 1.875 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
541892amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
687043amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
577957amphetamine aspartate 3.75 MG / amphetamine sulfate 3.75 MG / dextroamphetamine saccharate 3.75 MG / dextroamphetamine sulfate 3.75 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
577961amphetamine aspartate 5 MG / amphetamine sulfate 5 MG / dextroamphetamine saccharate 5 MG / dextroamphetamine sulfate 5 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
541363amphetamine aspartate 7.5 MG / amphetamine sulfate 7.5 MG / dextroamphetamine saccharate 7.5 MG / dextroamphetamine sulfate 7.5 MG Oral TabletSCDc907301d-e24d-9609-5529-fed14f94549f15
541892mixed amphetamine salts 10 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
687043mixed amphetamine salts 12.5 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
577957mixed amphetamine salts 15 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
577961mixed amphetamine salts 20 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
541363mixed amphetamine salts 30 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
541878mixed amphetamine salts 5 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15
1009145mixed amphetamine salts 7.5 MG Oral TabletSYc907301d-e24d-9609-5529-fed14f94549f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
47781-175-0147781017501100 in 1 BOTTLEHistorical
47781-175-0547781017505500 in 1 BOTTLEHistorical
47781-175-304778101753030 in 1 BOTTLEHistorical