Tolterodine Tartrate
Tolterodine Tartrate Tablets
Approved
Approval ID
c92baa43-be2d-4ac7-8632-ab8e71149a9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Drug Ocean LLC
DUNS: 080381835
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 Code70985-022
Application NumberANDA204721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 1 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
Tolterodine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70985-023
Application NumberANDA204721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB