Tolterodine Tartrate
These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE tartrate extended-release capsules, for oral use Initial U.S. Approval: December 2000
Approved
Approval ID
e16012ae-5972-470b-8a22-b0626a029e95
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2017
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-608
Application NumberANDA206419
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2017
FDA Product Classification
INGREDIENTS (19)
Tolterodine TartrateActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ETHYL ACRYLATEInactive
Code: 71E6178C9T
Classification: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Tolterodine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-607
Application NumberANDA206419
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2017
FDA Product Classification
INGREDIENTS (20)
Tolterodine TartrateActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHYLENE CHLORIDEInactive
Code: 588X2YUY0A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688
Classification: IACT
ETHYL ACRYLATEInactive
Code: 71E6178C9T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT