Rivastigmine Tartrate
Rivastigmine Tartrate Capsules, USP 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
2bb5e0d6-f677-4021-9888-3ff90979ef7d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-901
Application NumberANDA207797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (13)
RIVASTIGMINE TARTRATEActive
Quantity: 3 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-900
Application NumberANDA207797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
RIVASTIGMINE TARTRATEActive
Quantity: 1.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-902
Application NumberANDA207797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
RIVASTIGMINE TARTRATEActive
Quantity: 4.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-903
Application NumberANDA207797
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2023
FDA Product Classification
INGREDIENTS (13)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
RIVASTIGMINE TARTRATEActive
Quantity: 6 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM