Zenzedi
ZENZEDI (DEXTROAMPHETAMINE SULFATE TABLETS, USP) CII
Approved
Approval ID
d6394df5-f2c9-47eb-b57e-f3e9cfd94f84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
AZURITY PHARMACEUTICALS, INC.
DUNS: 117505635
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-850
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (5)
Dextroamphetamine SulfateActive
Quantity: 2.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-852
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Dextroamphetamine SulfateActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-853
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Dextroamphetamine SulfateActive
Quantity: 10 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-855
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (7)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Dextroamphetamine SulfateActive
Quantity: 20 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C Red NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-851
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (7)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Dextroamphetamine SulfateActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-856
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
Dextroamphetamine SulfateActive
Quantity: 30 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Dextroamphetamine Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-854
Application NumberANDA090533
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dextroamphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (8)
Dextroamphetamine SulfateActive
Quantity: 15 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT