Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
70518-4388
11-digit product format
705184388
Labeler code
70518
Product ID
70518-4388_39566a39-b9f2-4b9c-e063-6394a90aff7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090149
Marketing category
ANDA
Marketing start
2025-07-06
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5; 40 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
2026-12-31
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
70518-4388-07051843880090 CAPSULE in 1 BOTTLE, PLASTIC (70518-4388-0) 90 capsule2025-07-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amlodipine Besylate and Benazepril HydrochlorideREMEDYREPACK INC.2025-07-07HUMAN PRESCRIPTION DRUG LABEL1