Tolterodine Tartrate

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Hetero Labs Limited Unit III

Labeler

Camber Pharmaceuticals, Inc.

DUNS Number

676162024

Products2

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

Product Details

NDC Product Code

31722-608

Application Number

ANDA206419

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 2, 2017

Ingredients

TolterodineActive

Code: 5T619TQR3RClass: ACTIBQuantity: 4 mg in 1 1

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

METHYLENE CHLORIDEInactive

Code: 588X2YUY0AClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ETHYL ACRYLATEInactive

Code: 71E6178C9TClass: IACT

METHYL METHACRYLATEInactive

Code: 196OC77688Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT