FDA.reportPublic FDA data

Zenzedi

Product NDC
24338-853
11-digit product format
243380853
Labeler code
24338
Product ID
24338-853_67939d07-156a-4af8-9520-3c0b146aa681
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextroamphetamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Azurity Pharmaceuticals, Inc.
Application
ANDA090533
Marketing category
ANDA
Marketing start
2013-05-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zenzedi
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROAMPHETAMINE SULFATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJJ768O327N
Rxcui884385, 884386, 884684, 1425337, 1425339, 1425847, 1425854, 1426251, 1426253, 1535451, 1535454, 1535456, 1535470, 1535472

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
24338-853-03Zenzedi30 in 1 BOTTLETABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-853-03EA - Each24338-85336fea343-e9d0-4244-b368-8397f2bae74912021-04-08
24338-853-10EA - Each24338-8534c3561ec-a8eb-4895-a24c-c1287f79a06f12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextroamphetamine SulfateACTIVE INGREDIENTJJ768O327NZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
DextroamphetamineACTIVE MOIETYTZ47U051FIZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
D&C Red NO. 27INACTIVE INGREDIENT2LRS185U6KZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOAZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [ARBOR PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24338-853ZENZEDI (DEXTROAMPHETAMINE SULFATE) TABLET [AZURITY PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20231111_d6394df5-f2c9-47eb-b57e-f3e9cfd94f84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884385dextroamphetamine sulfate 10 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
884684dextroamphetamine sulfate 15 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425847dextroamphetamine sulfate 2.5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535454dextroamphetamine sulfate 20 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535470dextroamphetamine sulfate 30 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
884386dextroamphetamine sulfate 5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425854dextroamphetamine sulfate 7.5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425337Zenzedi 10 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535451Zenzedi 15 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426251Zenzedi 2.5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535456Zenzedi 20 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535472Zenzedi 30 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425339Zenzedi 5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426253Zenzedi 7.5 MG Oral TabletPSNd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425337dextroamphetamine sulfate 10 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535451dextroamphetamine sulfate 15 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426251dextroamphetamine sulfate 2.5 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535456dextroamphetamine sulfate 20 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535472dextroamphetamine sulfate 30 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425339dextroamphetamine sulfate 5 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426253dextroamphetamine sulfate 7.5 MG Oral Tablet [Zenzedi]SBDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
884385dextroamphetamine sulfate 10 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
884684dextroamphetamine sulfate 15 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425847dextroamphetamine sulfate 2.5 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535454dextroamphetamine sulfate 20 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535470dextroamphetamine sulfate 30 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
884386dextroamphetamine sulfate 5 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425854dextroamphetamine sulfate 7.5 MG Oral TabletSCDd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425337Zenzedi 10 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535451Zenzedi 15 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426251Zenzedi 2.5 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535456Zenzedi 20 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1535472Zenzedi 30 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1425339Zenzedi 5 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414
1426253Zenzedi 7.5 MG Oral TabletSYd6394df5-f2c9-47eb-b57e-f3e9cfd94f8414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24338-853-032433808530330 TABLET in 1 BOTTLE (24338-853-03) 30 tablet2021-03-120000-00-00NoNoCurrent
24338-853-1024338085310100 TABLET in 1 BOTTLE (24338-853-10) 100 tablet2013-05-310000-00-00NoNoCurrent