Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
63629-1454
11-digit product format
636291454
Labeler code
63629
Product ID
63629-1454_ee0407b7-bc98-2efb-e053-2995a90a9e79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077183
Marketing category
ANDA
Marketing start
2010-04-19
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1454-16362914540130 CAPSULE in 1 BOTTLE (63629-1454-1) 30 capsule2011-01-210000-00-00NoNoCurrent
63629-1454-26362914540290 CAPSULE in 1 BOTTLE (63629-1454-2) 90 capsule2011-01-210000-00-00NoNoCurrent
63629-1454-36362914540360 CAPSULE in 1 BOTTLE (63629-1454-3) 60 capsule2011-01-210000-00-00NoNoCurrent