NDC 25208-200

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 ID25208-200_07378b11-02d3-40f6-bea5-90ac775b04ed
NDC25208-200
Product TypeHuman Prescription Drug
Proprietary NameZYPITAMAG
Generic NamePitavastatin Magnesium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-03-09
Marketing End Date2021-05-31
Marketing CategoryNDA / NDA
Application NumberNDA208379
Labeler NameMedicure International Inc
Substance NamePITAVASTATIN
Active Ingredient Strength1 mg/1
Pharm ClassesHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],HMG-CoA Reductase Inhibitor [EPC]
NDC Exclude FlagN

Packaging

NDC 25208-200-12

10 BLISTER PACK in 1 CARTON (25208-200-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-03-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25208-200-13 [25208020013]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2019-10-01

NDC 25208-200-12 [25208020012]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2019-10-01

NDC 25208-200-14 [25208020014]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2019-10-01

NDC 25208-200-09 [25208020009]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-03-09
Marketing End Date2021-05-31

NDC 25208-200-15 [25208020015]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2019-10-01

NDC 25208-200-10 [25208020010]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2020-07-31

NDC 25208-200-11 [25208020011]

ZYPITAMAG TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208379
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-09
Marketing End Date2019-10-01

Drug Details

Active Ingredients

IngredientStrength
PITAVASTATIN1 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.