Tolterodine Tartrate

Tolterodine Tartrate Tablets

Approved

Approval ID

ab35eeae-d23a-505b-e053-2a95a90a005a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 23, 2023

Manufacturers

FDA

Athem LLC

DUNS: 117077124

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolterodine Tartarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code73152-027

Application NumberANDA210775

Product Classification

Marketing Category

C73584

Generic Name

Tolterodine Tartarate

Product Specifications

Route of AdministrationORAL

Effective DateMarch 23, 2023

FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

TOLTERODINE TARTRATEActive

Quantity: 2 mg in 1 1

Code: 5T619TQR3R

Classification: ACTIB

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM STARCH GLYCOLATE TYPE B POTATOInactive

Code: 27NA468985

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT