DEXTROAMPHETAMINE SULFATE

Product NDC
68382-942
11-digit product format
683820942
Labeler code
68382
Product ID
68382-942_282d4715-9c0f-484a-a6b3-aac87feb347c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROAMPHETAMINE SULFATE
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA206588
Marketing category
ANDA
Marketing start
2016-03-28
Marketing end
0000-00-00
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
10 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-942-012022-07-29C16284748780-1e4f33bdf-b1da-d8a0-e053-dadaa90a6e4eDEXTROAMPHETAMINE SULFATE - dextroamphetamine sulfate tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-942-01DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-942-01EA - Each68382-9423863c0c3-03a0-4cb8-b82e-ceb699ea916912016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-942DEXTROAMPHETAMINE SULFATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC. ]7Legacy NDC, 1 package rows20211218_0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSN0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e7
884386dextroamphetamine sulfate 5 MG Oral TabletPSN0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e7
884385dextroamphetamine sulfate 10 MG Oral TabletSCD0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e7
884386dextroamphetamine sulfate 5 MG Oral TabletSCD0d50f495-f1e0-4231-b0c3-6ebb7ad68f4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-942-0168382094201100 TABLET in 1 BOTTLE (68382-942-01) 100 tablet2016-03-280000-00-00NoNoCurrent