Aripiprazole
ARIPIPRAZOLE orally disintegrating tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
5a885c62-e40b-4bd5-804d-285bbdac781e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 26, 2021
Manufacturers
FDA
OrchidPharma Inc
DUNS: 809429207
Products 2
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 Code42043-400
Application NumberANDA202547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2021
FDA Product Classification
INGREDIENTS (11)
ARIPIPRAZOLEActive
Quantity: 10 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Aripiprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42043-401
Application NumberANDA202547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Aripiprazole
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2021
FDA Product Classification
INGREDIENTS (11)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ARIPIPRAZOLEActive
Quantity: 15 mg in 1 1
Code: 82VFR53I78
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT