FDA.reportPublic FDA data

Amlodipine and Benazepril Hydrochloride

Product NDC
63629-7535
11-digit product format
636297535
Labeler code
63629
Product ID
63629-7535_41688c0a-638a-4c2c-b71e-837cceedcd4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202239
Marketing category
ANDA
Marketing start
2012-09-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, N1SN99T69T
Rxcui898342

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7535-12024-07-22C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
63629-7535-22024-07-22C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
63629-7535-32024-07-22C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
63629-7535-12024-01-30C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
63629-7535-22024-01-30C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995
63629-7535-32024-01-30C16284748780-11030e364-fac1-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7535-1Amlodipine and Benazepril Hydrochloride30 in 1 BOTTLECAPSULE3010
63629-7535-2Amlodipine and Benazepril Hydrochloride60 in 1 BOTTLECAPSULE6010
63629-7535-3Amlodipine and Benazepril Hydrochloride90 in 1 BOTTLECAPSULE9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7535AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 3 package rows20240724_30c401b5-decf-4c0c-8180-92a9b3d7d0fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN30c401b5-decf-4c0c-8180-92a9b3d7d0fb10
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD30c401b5-decf-4c0c-8180-92a9b3d7d0fb10
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY30c401b5-decf-4c0c-8180-92a9b3d7d0fb10
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY30c401b5-decf-4c0c-8180-92a9b3d7d0fb10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7535-16362975350130 CAPSULE in 1 BOTTLE (63629-7535-1) 30 capsule2018-02-130000-00-00NoNoCurrent
63629-7535-26362975350260 CAPSULE in 1 BOTTLE (63629-7535-2) 60 capsule2024-07-080000-00-00NoNoCurrent
63629-7535-36362975350390 CAPSULE in 1 BOTTLE (63629-7535-3) 90 capsule2018-06-220000-00-00NoNoCurrent