FDA.reportPublic FDA data

Lotrel

Product NDC
0078-0384
11-digit product format
000780384
Labeler code
0078
Product ID
0078-0384_46cca24f-f00e-4616-8d39-f0a2812ec2d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and benazepril hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020364
Marketing category
NDA
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
No
Listing certified through
2019-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0384-05EA - Each0078-03844e2c6de3-c8b0-4adb-abdd-8067be20fb8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
AMLODIPINEACTIVE MOIETY1J444QC288LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
BENAZEPRILATACTIVE MOIETYJRM708L703LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOTREL (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10 MG / 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Lotrel 10 MG / 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Lotrel 5 MG / 10 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Lotrel 5 MG / 20 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Lotrel 5 MG / 40 MG Oral CapsulePSN4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344amlodipine 10 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348amlodipine 10 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355amlodipine 5 MG / benazepril hydrochloride 10 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358amlodipine 5 MG / benazepril hydrochloride 20 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361amlodipine 5 MG / benazepril hydrochloride 40 MG Oral Capsule [Lotrel]SBD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Amlodipine 10 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Amlodipine 10 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Amlodipine 5 MG / BZP hydrochloride 10 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Amlodipine 5 MG / BZP hydrochloride 20 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Amlodipine 5 MG / BZP hydrochloride 40 MG Oral Capsule [Lotrel]SY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10/20 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898344Lotrel 10/20 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Lotrel 10/40 (amlodipine / benazepril) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898348Lotrel 10/40 Oral TabletSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352Lotrel 2.5/10 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898352Lotrel 2.5/10 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Lotrel 5/10 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898355Lotrel 5/10 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Lotrel 5/20 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898358Lotrel 5/20 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Lotrel 5/40 (amlodipine / benazepril HCl) Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3
898361Lotrel 5/40 Oral CapsuleSY4653cabc-f249-4b4e-95b6-5fb4ddc0ad5d3