Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
68151-1365
11-digit product format
681511365
Labeler code
68151
Product ID
68151-1365_21e57f79-f56c-490f-a0b7-40799e7e50f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and benazepril hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020364
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1995-03-03
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1365-0Amlodipine Besylate and Benazepril Hydrochloride1 in 1 PACKAGECAPSULE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1365AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140707_f40161f0-7b9e-4131-92d6-893cb9473e71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNf40161f0-7b9e-4131-92d6-893cb9473e712
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDf40161f0-7b9e-4131-92d6-893cb9473e712
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYf40161f0-7b9e-4131-92d6-893cb9473e712
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYf40161f0-7b9e-4131-92d6-893cb9473e712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1365-0681511365001 in 1 PACKAGEHistorical