NDC 0781-5628

AMLODIPINE AND VALSARTAN

Amlodipine Besylate And Valsartan

AMLODIPINE AND VALSARTAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Amlodipine Besylate; Valsartan.

Product ID0781-5628_054546f4-f406-4a5c-91ba-d981071cf38b
NDC0781-5628
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE AND VALSARTAN
Generic NameAmlodipine Besylate And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-03-30
Marketing End Date2022-09-30
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021990
Labeler NameSandoz Inc
Substance NameAMLODIPINE BESYLATE; VALSARTAN
Active Ingredient Strength10 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

Packaging

NDC 0781-5628-31

30 TABLET, FILM COATED in 1 BOTTLE (0781-5628-31)
Marketing Start Date2015-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5628-31 [00781562831]

AMLODIPINE AND VALSARTAN TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA021990
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-30
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:cc0fa546-063a-434f-b8c0-bfca5b34462c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722126
  • 722137
  • 722131
  • 722134
  • 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 "AMLODIPINE AND VALSARTAN" or generic name "Amlodipine Besylate And Valsartan"

    NDCBrand NameGeneric Name
    0093-7690Amlodipine and ValsartanAmlodipine and Valsartan
    0093-7692Amlodipine and ValsartanAmlodipine and Valsartan
    0093-7693Amlodipine and ValsartanAmlodipine and Valsartan
    0378-1721AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1722AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1723AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0378-1724AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    0781-5615AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5628AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    0781-5639AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    68180-765Amlodipine and ValsartanAmlodipine and Valsartan
    68180-767Amlodipine and ValsartanAmlodipine and Valsartan
    68180-764Amlodipine and ValsartanAmlodipine and Valsartan
    68180-766Amlodipine and ValsartanAmlodipine and Valsartan
    0781-5643AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    13668-204Amlodipine and ValsartanAmlodipine and Valsartan
    13668-206Amlodipine and ValsartanAmlodipine and Valsartan
    13668-205Amlodipine and ValsartanAmlodipine and Valsartan
    13668-207Amlodipine and ValsartanAmlodipine and Valsartan
    40032-080Amlodipine and ValsartanAmlodipine and Valsartan
    40032-081Amlodipine and ValsartanAmlodipine and Valsartan
    40032-082Amlodipine and ValsartanAmlodipine and Valsartan
    40032-083AMLODIPINE and VALSARTANAMLODIPINE and VALSARTAN
    42291-023Amlodipine and ValsartanAmlodipine and Valsartan
    42291-021Amlodipine and ValsartanAmlodipine and Valsartan
    42291-020Amlodipine and ValsartanAmlodipine and Valsartan
    42291-022Amlodipine and ValsartanAmlodipine and Valsartan
    43386-082Amlodipine and ValsartanAmlodipine and Valsartan
    43386-080Amlodipine and ValsartanAmlodipine and Valsartan
    43386-081Amlodipine and ValsartanAmlodipine and Valsartan
    43386-083AMLODIPINE and VALSARTANAMLODIPINE and VALSARTAN
    45865-880Amlodipine and ValsartanAmlodipine and Valsartan
    45865-889Amlodipine and ValsartanAmlodipine and Valsartan
    46708-460Amlodipine and ValsartanAmlodipine and Valsartan
    45865-890Amlodipine and valsartanAmlodipine and valsartan
    45865-882Amlodipine and ValsartanAmlodipine and Valsartan
    46708-461Amlodipine and ValsartanAmlodipine and Valsartan
    46708-458Amlodipine and ValsartanAmlodipine and Valsartan
    46708-459Amlodipine and ValsartanAmlodipine and Valsartan
    49884-574Amlodipine and ValsartanAmlodipine and Valsartan
    49884-576Amlodipine and ValsartanAmlodipine and Valsartan
    49884-575Amlodipine and ValsartanAmlodipine and Valsartan
    49884-577Amlodipine and ValsartanAmlodipine and Valsartan
    50090-2471AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTAN
    57297-766Amlodipine and ValsartanAmlodipine and Valsartan
    57297-767Amlodipine and ValsartanAmlodipine and Valsartan
    57297-765Amlodipine and ValsartanAmlodipine and Valsartan
    57297-764Amlodipine and ValsartanAmlodipine and Valsartan
    62332-206Amlodipine and ValsartanAmlodipine and Valsartan
    62332-208Amlodipine and ValsartanAmlodipine and Valsartan

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