Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
68788-8168
11-digit product format
687888168
Labeler code
68788
Product ID
68788-8168_a43cc30e-7878-4cb9-a579-4b5542c0724e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077183
Marketing category
ANDA
Marketing start
2022-04-08
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [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
68788-8168-3EA - Each68788-8168f7a8a264-b72c-4720-aafb-0df4636d45af12022-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8168-36878881680330 CAPSULE in 1 BOTTLE (68788-8168-3) 30 capsule2022-04-080000-00-00NoNoCurrent