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
d4eda27a-0c99-48a2-a973-03c5267634da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2022
Manufacturers
FDA
Breckenridge Pharmaceutical, Inc
DUNS: 150554335
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 Code51991-796
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2022
FDA Product Classification
INGREDIENTS (9)
RIVASTIGMINE TARTRATEActive
Quantity: 6 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Rivastigmine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-794
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2022
FDA Product Classification
INGREDIENTS (9)
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
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code51991-793
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2022
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RIVASTIGMINE TARTRATEActive
Quantity: 1.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
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 Code51991-795
Application NumberANDA091689
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rivastigmine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2022
FDA Product Classification
INGREDIENTS (8)
RIVASTIGMINE TARTRATEActive
Quantity: 4.5 mg in 1 1
Code: 9IY2357JPE
Classification: ACTIM
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT