NDC 0378-5815

Valsartan

Valsartan

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 Valsartan.

Product ID0378-5815_30667a3d-722a-4a73-9a88-4357a5d31779
NDC0378-5815
Product TypeHuman Prescription Drug
Proprietary NameValsartan
Generic NameValsartan
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-05
Marketing CategoryANDA / ANDA
Application NumberANDA090866
Labeler NameMylan Pharmaceuticals Inc.
Substance NameVALSARTAN
Active Ingredient Strength320 mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-5815-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5815-77)
Marketing Start Date2015-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5815-01 [00378581501]

Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090866
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-05
Marketing End Date2017-05-03

NDC 0378-5815-77 [00378581577]

Valsartan TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090866
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-05

Drug Details

Active Ingredients

IngredientStrength
VALSARTAN320 mg/1

OpenFDA Data

SPL SET ID:73e01dc6-7dd4-421a-a4f6-137e75f69f9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349483
  • 349201
  • 349200
  • 349199
  • UPC Code
  • 0303785814771
  • 0303785807933
  • 0303785813774
  • 0303785815778
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]

    NDC Crossover Matching brand name "Valsartan" or generic name "Valsartan"

    NDCBrand NameGeneric Name
    0378-5807Valsartanvalsartan
    0378-5813Valsartanvalsartan
    0378-5814Valsartanvalsartan
    0378-5815Valsartanvalsartan
    0591-2167Valsartanvalsartan
    0591-2168Valsartanvalsartan
    0591-2169Valsartanvalsartan
    0591-2170Valsartanvalsartan
    0781-5607Valsartanvalsartan
    0781-5608Valsartanvalsartan
    0781-5618Valsartanvalsartan
    0781-5619Valsartanvalsartan
    0904-6594Valsartanvalsartan
    0904-6595Valsartanvalsartan
    10135-768ValsartanValsartan
    10135-769ValsartanValsartan
    10135-770ValsartanValsartan
    10135-771ValsartanValsartan
    67877-416ValsartanValsartan
    67877-418ValsartanValsartan
    67877-417ValsartanValsartan
    67877-415ValsartanValsartan
    68180-278ValsartanValsartan
    68180-277ValsartanValsartan
    68180-279ValsartanValsartan
    68180-276ValsartanValsartan
    68788-6814ValsartanValsartan
    68788-6882ValsartanValsartan
    70518-0069ValsartanValsartan
    70518-1279ValsartanValsartan
    71335-0097ValsartanValsartan
    71335-0567ValsartanValsartan
    71335-0600ValsartanValsartan
    71335-0475ValsartanValsartan
    71335-0488ValsartanValsartan
    76483-026ValsartanValsartan
    76483-024ValsartanValsartan
    76483-023ValsartanValsartan
    76483-025ValsartanValsartan
    13668-067valsartanvalsartan
    13668-068valsartanvalsartan
    13668-069valsartanvalsartan
    13668-070valsartanvalsartan
    29300-235ValsartanValsartan
    29300-232ValsartanValsartan
    31722-747ValsartanValsartan
    29300-233ValsartanValsartan
    29300-234ValsartanValsartan
    31722-748ValsartanValsartan
    33342-062ValsartanValsartan

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