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
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
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