FDA.reportPublic FDA data

Evekeo

Product NDC
24338-026
11-digit product format
243380026
Labeler code
24338
Product ID
24338-026_d0fd9643-77a8-4810-94f5-f0ab06e4212f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
ANDA200166
Marketing category
ANDA
Marketing start
2015-11-01
Substance
AMPHETAMINE 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHETAMINE SULFATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6DPV8NK46S
Rxcui884655, 1600695, 1600698, 1600700

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
24338-026-03Evekeo30 in 1 BOTTLETABLET309
24338-026-10Evekeo100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-026-03EA - Each24338-026b2fc53a5-4d2c-44b7-acd3-939de331f38d12021-04-08
24338-026-10EA - Each24338-026b3b98be8-8a1f-4609-af46-315f9763dc6212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amphetamine SulfateACTIVE INGREDIENT6DPV8NK46SEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
AmphetamineACTIVE MOIETYCK833KGX7EEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
crospovidoneINACTIVE INGREDIENT68401960MKEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APEVEKEO (AMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-026EVEKEO (AMPHETAMINE SULFATE) TABLET [AZURITY PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20231101_f469fb38-0380-4621-9db3-a4f429126156.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600695amphetamine sulfate 10 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
884655amphetamine sulfate 5 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600698Evekeo 10 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600700Evekeo 5 MG Oral TabletPSNf469fb38-0380-4621-9db3-a4f4291261569
1600698amphetamine sulfate 10 MG Oral Tablet [Evekeo]SBDf469fb38-0380-4621-9db3-a4f4291261569
1600700amphetamine sulfate 5 MG Oral Tablet [Evekeo]SBDf469fb38-0380-4621-9db3-a4f4291261569
1600695amphetamine sulfate 10 MG Oral TabletSCDf469fb38-0380-4621-9db3-a4f4291261569
884655amphetamine sulfate 5 MG Oral TabletSCDf469fb38-0380-4621-9db3-a4f4291261569
1600698Evekeo 10 MG Oral TabletSYf469fb38-0380-4621-9db3-a4f4291261569
1600700Evekeo 5 MG Oral TabletSYf469fb38-0380-4621-9db3-a4f4291261569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-026-032433800260330 TABLET in 1 BOTTLE (24338-026-03) 30 tablet2021-03-120000-00-00NoNoCurrent
24338-026-1024338002610100 TABLET in 1 BOTTLE (24338-026-10) 100 tablet2015-11-010000-00-00NoNoCurrent