NDC 0078-0488

Exforge

Amlodipine Besylate And Valsartan

Exforge is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Amlodipine Besylate; Valsartan.

Product ID0078-0488_16f31180-e5cf-4747-95a8-2d0fd218a9b6
NDC0078-0488
Product TypeHuman Prescription Drug
Proprietary NameExforge
Generic NameAmlodipine Besylate And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-20
Marketing CategoryNDA / NDA
Application NumberNDA021990
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameAMLODIPINE BESYLATE; VALSARTAN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0078-0488-15

30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)
Marketing Start Date2007-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0488-61 [00078048861]

Exforge TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-20
Marketing End Date2011-01-31

NDC 0078-0488-30 [00078048830]

Exforge TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-19
Marketing End Date2015-08-11

NDC 0078-0488-35 [00078048835]

Exforge TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-20
Marketing End Date2011-01-31

NDC 0078-0488-15 [00078048815]

Exforge TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-20

NDC 0078-0488-34 [00078048834]

Exforge TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-06-20
Marketing End Date2014-06-19

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:d0caec89-96ec-411d-a933-63eda74a6da7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 724895
  • 722131
  • 724879
  • 724887
  • 724891
  • 722137
  • 722126
  • 722134
  • UPC Code
  • 0300780491150
  • Pharmacological Class

    • Calcium Channel Antagonists [MoA]
    • Dihydropyridine Calcium Channel Blocker [EPC]
    • Dihydropyridines [CS]
    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    NDC Crossover Matching brand name "Exforge" or generic name "Amlodipine Besylate And Valsartan"

    NDCBrand NameGeneric Name
    0078-0488Exforgeamlodipine besylate and valsartan
    0078-0489Exforgeamlodipine besylate and valsartan
    0078-0490Exforgeamlodipine besylate and valsartan
    0078-0491Exforgeamlodipine besylate and valsartan
    0781-5615AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5628AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5639AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5643AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    50090-2471AMLODIPINE AND VALSARTANamlodipine besylate and valsartan

    Trademark Results [Exforge]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXFORGE
    EXFORGE
    78905845 3490550 Live/Registered
    Novartis AG
    2006-06-12
    EXFORGE
    EXFORGE
    78089458 2764146 Live/Registered
    Novartis AG
    2001-10-22

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