NDC 25208-202

ZYPITAMAG

Pitavastatin Magnesium

ZYPITAMAG is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Medicure International Inc. The primary component is Pitavastatin.

Product ID25208-202_07378b11-02d3-40f6-bea5-90ac775b04ed
NDC25208-202
Product TypeHuman Prescription Drug
Proprietary NameZYPITAMAG
Generic NamePitavastatin Magnesium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-09
Marketing CategoryNDA / NDA
Application NumberNDA208379
Labeler NameMedicure International Inc
Substance NamePITAVASTATIN
Active Ingredient Strength4 mg/1
Pharm ClassesHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 25208-202-09

90 TABLET, FILM COATED in 1 BOTTLE (25208-202-09)
Marketing Start Date2018-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25208-202-12 [25208020212]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

NDC 25208-202-11 [25208020211]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

NDC 25208-202-09 [25208020209]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-09

NDC 25208-202-14 [25208020214]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

NDC 25208-202-10 [25208020210]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

NDC 25208-202-13 [25208020213]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

NDC 25208-202-15 [25208020215]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09

Drug Details

Active Ingredients

IngredientStrength
PITAVASTATIN4 mg/1

OpenFDA Data

SPL SET ID:c8c50e03-5cb8-43f4-bdef-8edd12f1945f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2001254
  • 2001268
  • 2001266
  • 2001264
  • 2001262
  • 2001260
  • UPC Code
  • 0325208202101
  • 0325208200107
  • 0325208201104
  • Pharmacological Class

    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    • HMG-CoA Reductase Inhibitor [EPC]

    NDC Crossover Matching brand name "ZYPITAMAG" or generic name "Pitavastatin Magnesium"

    NDCBrand NameGeneric Name
    25208-200ZYPITAMAGPitavastatin Magnesium
    25208-201ZYPITAMAGPitavastatin Magnesium
    25208-202ZYPITAMAGPitavastatin Magnesium
    70771-1116ZYPITAMAGPitavastatin Magnesium
    70771-1117ZYPITAMAGPitavastatin Magnesium
    70771-1118ZYPITAMAGPitavastatin Magnesium

    Trademark Results [ZYPITAMAG]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZYPITAMAG
    ZYPITAMAG
    87730057 not registered Live/Pending
    Cadila Healthcare Limited
    2017-12-21

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.