Amphetamine Sulfate

Product NDC
69238-1563
11-digit product format
692381563
Labeler code
69238
Product ID
69238-1563_940571ac-35e3-426e-8eb0-386a3987c3b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211139
Marketing category
ANDA
Marketing start
2018-09-28
Substance
AMPHETAMINE 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
Amphetamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE SULFATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6DPV8NK46S
Rxcui884655, 1600695

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
4496d022-9224-4ee0-943a-50fbe6cd7123Product name220220901
2a7aa275-a4ca-44eb-971f-47427a374085Product name920220615
93730fbf-8b45-4623-b27d-cf03825d04b3Product name520220314
57953747-955c-4dd8-9164-49d8ea877eaeProduct name120171113
fcc7ea58-a369-4e91-b092-5cde9ac2669fProduct name120160224

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1563-1Amphetamine Sulfate100 in 1 BOTTLETABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1563-1EA - Each69238-1563881c6947-d697-4f71-963f-4fe4b1ee8e3512018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1563AMPHETAMINE SULFATE (AMPHETAMINE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]17Current NDC, Legacy NDC, 1 package rows20250515_53d40847-e0d3-48ec-81a7-ec5478553565.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSN53d40847-e0d3-48ec-81a7-ec547855356518
884655amphetamine sulfate 5 MG Oral TabletPSN53d40847-e0d3-48ec-81a7-ec547855356518
1600695amphetamine sulfate 10 MG Oral TabletSCD53d40847-e0d3-48ec-81a7-ec547855356518
884655amphetamine sulfate 5 MG Oral TabletSCD53d40847-e0d3-48ec-81a7-ec547855356518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1563-169238156301100 TABLET in 1 BOTTLE (69238-1563-1) 100 tablet2018-09-280000-00-00NoNoCurrent