Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
69238-2687
11-digit product format
692382687
Labeler code
69238
Product ID
69238-2687_9c78bd64-01e2-4597-838a-947cdaba7ba2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA077215
Marketing category
ANDA
Marketing start
2026-04-14
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10; 20 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
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
864V2Q084HAMLODIPINE BESYLATE111470-99-6AMLODIPINE BESYLATE
N1SN99T69TBENAZEPRIL HYDROCHLORIDE86541-74-4BENAZEPRIL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2687-169238268701100 CAPSULE in 1 BOTTLE (69238-2687-1) 100 capsule2026-04-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine Besylate and Benazepril HydrochlorideAmneal Pharmaceuticals NY LLC2026-03-31HUMAN PRESCRIPTION DRUG LABEL1