NDC 0078-0384

Lotrel

Amlodipine Besylate And Benazepril Hydrochloride

Lotrel is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Amlodipine Besylate; Benazepril Hydrochloride.

Product ID0078-0384_46cca24f-f00e-4616-8d39-f0a2812ec2d1
NDC0078-0384
Product TypeHuman Prescription Drug
Proprietary NameLotrel
Generic NameAmlodipine Besylate And Benazepril Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1995-03-03
Marketing CategoryNDA / NDA
Application NumberNDA020364
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameAMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesCalcium 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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0078-0384-05

100 CAPSULE in 1 BOTTLE (0078-0384-05)
Marketing Start Date1995-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0384-05 [00078038405]

Lotrel CAPSULE
Marketing CategoryNDA
Application NumberNDA020364
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-03-03
Marketing End Date2016-06-30

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:94ae6054-b7ae-4212-a567-4f803af8f2c7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 898359
  • 898361
  • 898342
  • 898344
  • 898346
  • 898358
  • 898348
  • 898356
  • 898355
  • 898353
  • 898352
  • 898350
  • UPC Code
  • 0300780406055
  • Pharmacological Class

    • 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 Crossover Matching brand name "Lotrel" or generic name "Amlodipine Besylate And Benazepril Hydrochloride"

    NDCBrand NameGeneric Name
    0078-0364Lotrelamlodipine besylate and benazepril hydrochloride
    0078-0379Lotrelamlodipine besylate and benazepril hydrochloride
    0078-0384Lotrelamlodipine besylate and benazepril hydrochloride
    0078-0404Lotrelamlodipine besylate and benazepril hydrochloride
    0078-0405Lotrelamlodipine besylate and benazepril hydrochloride
    0078-0406Lotrelamlodipine besylate and benazepril hydrochloride
    55289-096LotrelLotrel
    55289-039LotrelLotrel
    0615-1397amlodipine besylate and benazepril hydrochlorideamlodipine besylate and benazepril hydrochloride
    0615-1398amlodipine besylate and benazepril hydrochlorideamlodipine besylate and benazepril hydrochloride
    0615-1399amlodipine besylate and benazepril hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2271Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2272Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2273Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2274Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2277Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    0781-2279Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    33261-823Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    33261-824Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    33261-825Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    33261-982Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    42254-073Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    42254-074Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    43063-233Amlodipine Besylate and Benazepril Hydrochlorideamlodipine besylate and benazepril hydrochloride
    43063-571Amlodipine Besylate and Benazepril HydrochlorideAmlodipine Besylate and Benazepril Hydrochloride
    49884-929Amlodipine besylate and benazepril hydrochlorideamlodipine besylate and benazepril hydrochloride
    49884-930Amlodipine besylate and benazepril hydrochlorideamlodipine besylate and benazepril hydrochloride

    Trademark Results [Lotrel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LOTREL
    LOTREL
    74489679 1939013 Live/Registered
    NOVARTIS CORPORATION
    1994-02-14

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