MedPath
FDA Product

Lisinopril and Hydrochlorothiazide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Lisinopril and Hydrochlorothiazide

60760-861

Regulatory Information

60760-861

ANDA076194

C73584

March 2, 2021

USA

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

063050751

Active Ingredients

FD&C BLUE NO. 2--ALUMINUM LAKE

Code: 4AQJ3LG584

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LISINOPRIL

Quantity: 20 mg in 1 1

Code: E7199S1YWR

Class Code: ACTIB

HYDROCHLOROTHIAZIDE

Quantity: 12.5 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

Active Moieties

LISINOPRIL ANHYDROUS

Code: 7Q3P4BS2FD

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

© Copyright 2025. All Rights Reserved by MedPath