lotrel

Generic: amlodipine besylate and benazepril hydrochloride

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lotrel
Generic Name amlodipine besylate and benazepril hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, benazepril hydrochloride 40 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0379
Product ID 0078-0379_b9db75d9-9d1e-4b2d-9876-5f5520feaecc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020364
Marketing Start 1995-03-03
Marketing End 2026-09-30

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780379
Hyphenated Format 0078-0379

Supplemental Identifiers

RxCUI
898342 898344 898346 898348 898353 898355 898356 898358
UNII
864V2Q084H N1SN99T69T

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lotrel (source: ndc)
Generic Name amlodipine besylate and benazepril hydrochloride (source: ndc)
Application Number NDA020364 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0078-0379-05)
source: ndc

Packages (1)

0078-0379-05 100 CAPSULE in 1 BOTTLE (0078-0379-05)

Ingredients (2)

amlodipine besylate (10 mg/1) benazepril hydrochloride (40 mg/1)

Linked Drug Pages (1)

Lotrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9db75d9-9d1e-4b2d-9876-5f5520feaecc", "openfda": {"unii": ["864V2Q084H", "N1SN99T69T"], "rxcui": ["898342", "898344", "898346", "898348", "898353", "898355", "898356", "898358"], "spl_set_id": ["94ae6054-b7ae-4212-a567-4f803af8f2c7"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0078-0379-05)", "package_ndc": "0078-0379-05", "marketing_end_date": "20260731", "marketing_start_date": "19950303"}], "brand_name": "Lotrel", "product_id": "0078-0379_b9db75d9-9d1e-4b2d-9876-5f5520feaecc", "dosage_form": "CAPSULE", "pharm_class": ["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]"], "product_ndc": "0078-0379", "generic_name": "amlodipine besylate and benazepril hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lotrel", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "BENAZEPRIL HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "NDA020364", "marketing_category": "NDA", "marketing_end_date": "20260930", "marketing_start_date": "19950303"}