Losartan Potassium

Basic Information

Product Name

Losartan Potassium

FDA Product Code

71610-082

Regulatory Information

NDC Product Code

71610-082

Application Number

ANDA090083

Marketing Category

C73584

Effective Date

December 14, 2017

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LOSARTAN POTASSIUM

Quantity: 50 mg in 1 1

Code: 3ST302B24A

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

LOSARTAN

Code: JMS50MPO89

Basic Information

Regulatory Information

Company Information

Active Ingredients

STARCH, CORN

MICROCRYSTALLINE CELLULOSE

LACTOSE MONOHYDRATE

MAGNESIUM STEARATE

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

HYDROXYPROPYL CELLULOSE

HYPROMELLOSE 2910 (6 MPA.S)

TITANIUM DIOXIDE

WATER

FD&C BLUE NO. 2

D&C YELLOW NO. 10

Active Moieties

LOSARTAN