Telmisartan

Basic Information

Product Name

Telmisartan

FDA Product Code

50090-5492

Regulatory Information

NDC Product Code

50090-5492

Application Number

ANDA202397

Marketing Category

C73584

Effective Date

March 22, 2018

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TELMISARTAN TABLETS safely and effectively. See full prescribing information for TELMISARTAN TABLETS. TELMISARTAN tablets, for oral useInitial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TELMISARTAN

Quantity: 80 mg in 1 1

Code: U5SYW473RQ

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MEGLUMINE

Code: 6HG8UB2MUY

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

Code: U5SYW473RQ

Telmisartan

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

MANNITOL

POVIDONE, UNSPECIFIED

MEGLUMINE

SODIUM HYDROXIDE

Active Moieties

TELMISARTAN