Rivastigmine Tartrate
These highlights do not include all the information needed to use Rivastigmine Tartrate Capsules USP safely and effectively. See full prescribing information for Rivastigmine Tartrate Capsules USP. Rivastigmine Tartrate Capsules USP, for oral use. Initial U.S. Approval: 2000
Approved
Approval ID
33e6a772-382d-45f5-9d45-966c07759367
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
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 Code46708-066
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (9)
RIVASTIGMINE TARTRATEActive
Quantity: 6 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-064
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (9)
RIVASTIGMINE TARTRATEActive
Quantity: 3 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-063
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
RIVASTIGMINE TARTRATEActive
Quantity: 1.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-065
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2023
FDA Product Classification
INGREDIENTS (8)
RIVASTIGMINE TARTRATEActive
Quantity: 4.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT