NDC 0378-1724

AMLODIPINE AND VALSARTAN

Amlodipine And Valsartan

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

Product ID0378-1724_9a29454b-55c7-4b82-b338-e306354fff83
NDC0378-1724
Product TypeHuman Prescription Drug
Proprietary NameAMLODIPINE AND VALSARTAN
Generic NameAmlodipine And Valsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-03-30
Marketing CategoryANDA / ANDA
Application NumberANDA090483
Labeler NameMylan Pharmaceuticals 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
Listing Certified Through2019-12-31

Packaging

NDC 0378-1724-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1724-93)
Marketing Start Date2015-03-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1724-05 [00378172405]

AMLODIPINE AND VALSARTAN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-30
Marketing End Date2016-10-06

NDC 0378-1724-77 [00378172477]

AMLODIPINE AND VALSARTAN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090483
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-30
Marketing End Date2016-10-06

NDC 0378-1724-93 [00378172493]

AMLODIPINE AND VALSARTAN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090483
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-30

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE10 mg/1

OpenFDA Data

SPL SET ID:aa7e7d95-520a-461c-b1b3-e588aeb6a613
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 722126
  • 722137
  • 722131
  • 722134
  • UPC Code
  • 0303781723930
  • 0303781724937
  • 0303781722933
  • 0303781721936
  • 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 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
    0781-5643AMLODIPINE AND VALSARTANamlodipine besylate and valsartan
    13668-204Amlodipine and ValsartanAmlodipine and Valsartan
    13668-205Amlodipine and ValsartanAmlodipine and Valsartan
    13668-206Amlodipine 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
    42291-020Amlodipine and Valsartanamlodipine and valsartan
    42291-021Amlodipine and Valsartanamlodipine and valsartan
    42291-022Amlodipine and Valsartanamlodipine and valsartan
    42291-023Amlodipine and Valsartanamlodipine and valsartan
    43386-080Amlodipine and ValsartanAmlodipine and Valsartan
    43386-081Amlodipine and ValsartanAmlodipine and Valsartan
    43386-082Amlodipine and ValsartanAmlodipine and Valsartan
    43386-083AMLODIPINE and VALSARTANAMLODIPINE and VALSARTAN
    45865-880Amlodipine and ValsartanAmlodipine and Valsartan
    45865-882Amlodipine and ValsartanAmlodipine and Valsartan
    45865-889Amlodipine and ValsartanAmlodipine 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
    46708-460Amlodipine and ValsartanAmlodipine and Valsartan
    45865-890Amlodipine 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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