Rivastigmine Tartrate
These highlights do not include all the information needed to use RIVASTIGMINE TARTRATE CAPSULES safely and effectively. See full prescribing information for RIVASTIGMINE TARTRATE CAPSULES. RIVASTIGMINE TARTRATE capsules, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
bac9ca81-db70-41aa-82af-6c5bb8496846
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-148
Application NumberANDA077131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (17)
RIVASTIGMINE TARTRATEActive
Quantity: 6 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-145
Application NumberANDA077131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (16)
RIVASTIGMINE TARTRATEActive
Quantity: 1.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-146
Application NumberANDA077131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (14)
RIVASTIGMINE TARTRATEActive
Quantity: 3 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-147
Application NumberANDA077131
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2019
FDA Product Classification
INGREDIENTS (15)
RIVASTIGMINE TARTRATEActive
Quantity: 4.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT