MedPath
FDA Product

Lotrel

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

Basic Information

Lotrel

0078-0406

Regulatory Information

0078-0406

NDA020364

C73594

August 1, 2023

USA

These highlights do not include all the information needed to use LOTREL safely and effectively. See full prescribing information for LOTREL. LOTREL (amlodipine and benazepril hydrochloride) capsules, for oral useInitial U.S. Approval: 1995

HUMAN PRESCRIPTION DRUG LABEL

29

Company Information

002147023

Active Ingredients

CALCIUM PHOSPHATE, UNSPECIFIED FORM

Code: 97Z1WI3NDX

Class Code: IACT

AMLODIPINE BESYLATE

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYDROGENATED CASTOR OIL

Code: ZF94AP8MEY

Class Code: IACT

BENAZEPRIL HYDROCHLORIDE

Quantity: 20 mg in 1 1

Code: N1SN99T69T

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

AMLODIPINE

Code: 1J444QC288

BENAZEPRILAT

Code: JRM708L703

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