Aripiprazole
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS
Approved
Approval ID
0f9b1fd8-a648-45c9-8655-14de07439f34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 2, 2023
Manufacturers
FDA
SQUARE PHARMACEUTICALS LIMITED
DUNS: 731487153
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-103
Application NumberANDA090165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 30 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-101
Application NumberANDA090165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-100
Application NumberANDA090165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76483-102
Application NumberANDA090165
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2023
FDA Product Classification
INGREDIENTS (6)
ARIPIPRAZOLEActive
Quantity: 20 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 6/15/2022