FDA.reportPublic FDA data

Dextroamphetamine Sulfate

Product NDC
75826-126
11-digit product format
758260126
Labeler code
75826
Product ID
75826-126_37ddfa9e-e495-a25f-e063-6394a90ac3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Winder Laboratories LLC
Application
ANDA212160
Marketing category
ANDA
Marketing start
2021-12-06
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
30 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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-126-10Dextroamphetamine Sulfate100 in 1 BOTTLE, PLASTICTABLET10011
75826-126-30Dextroamphetamine Sulfate30 in 1 BOTTLE, PLASTICTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-126-10EA - Each75826-126d38f1459-77af-4a97-b548-63c6b698c93012024-01-04
75826-126-30EA - Each75826-1266ff25a14-fc0f-40e4-9677-2c3619007d2712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-126DEXTROAMPHETAMINE SULFATE TABLET [WINDER LABORATORIES LLC]10Current NDC, Legacy NDC, 2 package rows20240814_ca1a8890-0675-4c9c-9716-6c28f975d827.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884684dextroamphetamine sulfate 15 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1425847dextroamphetamine sulfate 2.5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1535454dextroamphetamine sulfate 20 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1535470dextroamphetamine sulfate 30 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884386dextroamphetamine sulfate 5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
1425854dextroamphetamine sulfate 7.5 MG Oral TabletPSNca1a8890-0675-4c9c-9716-6c28f975d82711
884385dextroamphetamine sulfate 10 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
884684dextroamphetamine sulfate 15 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1425847dextroamphetamine sulfate 2.5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1535454dextroamphetamine sulfate 20 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1535470dextroamphetamine sulfate 30 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
884386dextroamphetamine sulfate 5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711
1425854dextroamphetamine sulfate 7.5 MG Oral TabletSCDca1a8890-0675-4c9c-9716-6c28f975d82711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-126-1075826012610100 TABLET in 1 BOTTLE, PLASTIC (75826-126-10) 100 tablet2023-03-240000-00-00NoNoCurrent
75826-126-307582601263030 TABLET in 1 BOTTLE, PLASTIC (75826-126-30) 30 tablet2023-03-240000-00-00NoNoCurrent