Detrol
Detrol tolterodine tartrate tablets
Approved
Approval ID
42f819c9-4108-4ca7-92c5-a213037dd4db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2021
Manufacturers
FDA
PHARMACIA & UPJOHN COMPANY LLC
DUNS: 618054084
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tolterodine tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-4544
Application NumberNDA020771
Product Classification
M
Marketing Category
C73594
G
Generic Name
tolterodine tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2021
FDA Product Classification
INGREDIENTS (7)
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
tolterodine tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-4541
Application NumberNDA020771
Product Classification
M
Marketing Category
C73594
G
Generic Name
tolterodine tartrate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2021
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 1 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT