Lotrel

Product NDC
55289-096
11-digit product format
552890096
Labeler code
55289
Product ID
55289-096_e4438551-6396-3528-e053-2995a90a38ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and benazepril hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA020364
Marketing category
NDA
Marketing start
1995-03-03
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-096-30EA - Each55289-096332c5235-08c3-42e7-adb8-53d6d0978a8712012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-096-305528900963030 CAPSULE in 1 BOTTLE, PLASTIC (55289-096-30) 30 capsule2011-10-100000-00-00NoNoCurrent