Amlodipine and Benazepril Hydrochloride

Product NDC
23155-921
11-digit product format
231550921
Labeler code
23155
Product ID
23155-921_a67556d8-dd62-45ca-bdad-2e2659caa6f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA091431
Marketing category
ANDA
Marketing start
2026-05-23
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5; 10 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

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Benazepril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
BENAZEPRIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T, 864V2Q084H
Rxcui898342, 898346, 898350, 898353, 898356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-921-0123155092101100 CAPSULE in 1 BOTTLE (23155-921-01) 100 capsule2026-05-23NoNoHistorical
23155-921-0523155092105500 CAPSULE in 1 BOTTLE (23155-921-05) 500 capsule2026-05-23NoNoHistorical
23155-921-10231550921101000 CAPSULE in 1 BOTTLE (23155-921-10) 1000 capsule2026-05-23NoNoHistorical