FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
0781-2272
11-digit product format
007812272
Labeler code
0781
Product ID
0781-2272_ee885922-cc1f-4cf5-89ff-43714520d1fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and benazepril hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0781-2272-012021-12-24C16284748780-19d75b9d1-19f5-f424-e053-dadaa90a57ce6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2272-102021-12-24C16284748780-19d75b9d1-19f5-f424-e053-dadaa90a57ce6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2272-012020-01-31C16284748780-19d75b9d1-19f5-f424-e053-dadaa90a57ce6d0c2df4-e9db-4622-95e8-33aa8a08f593
0781-2272-102020-01-31C16284748780-19d75b9d1-19f5-f424-e053-dadaa90a57ce6d0c2df4-e9db-4622-95e8-33aa8a08f593

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2272-01EA - Each0781-22721fcb1174-53db-40aa-9af3-0aea99d1f2b212012-07-24
0781-2272-10EA - Each0781-22720b8ca283-5497-4fad-bbc1-3a6f844a63cd12012-07-24
0781-2272-64EA - Each0781-22725b704a32-84e6-4e16-80b5-a3407e50bb3812013-02-11

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN1c20ce12-06d3-4060-9936-ea847a5250532
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD1c20ce12-06d3-4060-9936-ea847a5250532
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY1c20ce12-06d3-4060-9936-ea847a5250532