Dextroamphetamine Sulfate

Product NDC
0555-0952
11-digit product format
005550952
Labeler code
0555
Product ID
0555-0952_05934bca-3ed9-4ce3-ba1d-2063930aad63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA040361
Marketing category
ANDA
Marketing start
2001-02-12
Substance
DEXTROAMPHETAMINE SULFATE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], 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 Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884385, 884386

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
0555-0952-02Dextroamphetamine Sulfate100 in 1 BOTTLETABLET10022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0952-02EA - Each0555-0952bccea31d-a31a-4c01-b20c-d20c8950346612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0952DEXTROAMPHETAMINE SULFATE TABLET [TEVA PHARMACEUTICALS USA, INC.]21Current NDC, Legacy NDC, 1 package rows20231016_ec2d13f3-d14f-47e4-abe9-7763f95a8e94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNec2d13f3-d14f-47e4-abe9-7763f95a8e9422
884386dextroamphetamine sulfate 5 MG Oral TabletPSNec2d13f3-d14f-47e4-abe9-7763f95a8e9422
884385dextroamphetamine sulfate 10 MG Oral TabletSCDec2d13f3-d14f-47e4-abe9-7763f95a8e9422
884386dextroamphetamine sulfate 5 MG Oral TabletSCDec2d13f3-d14f-47e4-abe9-7763f95a8e9422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0952-0200555095202100 TABLET in 1 BOTTLE (0555-0952-02) 100 tablet2001-02-120000-00-00NoNoCurrent