FDA.reportPublic FDA data

DEXTROAMPHETAMINE SULFATE

Product NDC
72162-1233
11-digit product format
721621233
Labeler code
72162
Product ID
72162-1233_b98dbd7a-41a8-40ab-bab6-769dcb663abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextroamphetamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210059
Marketing category
ANDA
Marketing start
2018-07-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROAMPHETAMINE SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884386

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
72162-1233-1DEXTROAMPHETAMINE SULFATE100 in 1 BOTTLETABLET100103
72162-1233-3DEXTROAMPHETAMINE SULFATE30 in 1 BOTTLETABLET30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1233-1EA - Each72162-12336799ae13-7975-4f12-b8db-27763426674612023-12-05
72162-1233-3EA - Each72162-123350d14ab7-7c1a-467a-9edd-ac4616074d4b12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1233DEXTROAMPHETAMINE SULFATE TABLET [BRYANT RANCH PREPACK]103Current NDC, 2 package rows20240919_5c493bef-0c3e-49f5-b55a-f1446094f5da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884386dextroamphetamine sulfate 5 MG Oral TabletPSN5c493bef-0c3e-49f5-b55a-f1446094f5da103
884386dextroamphetamine sulfate 5 MG Oral TabletSCD5c493bef-0c3e-49f5-b55a-f1446094f5da103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1233-172162123301100 TABLET in 1 BOTTLE (72162-1233-1) 100 tablet2024-09-06NoNoHistorical
72162-1233-37216212330330 TABLET in 1 BOTTLE (72162-1233-3) 30 tablet2024-09-06NoNoHistorical