NDC 64011-247

Makena

Hydroxyprogesterone Caproate

Makena is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Amag Pharmaceuticals, Inc.. The primary component is Hydroxyprogesterone Caproate.

Product ID64011-247_2586f54d-3cef-46fe-b5e8-1dc9a9861ee3
NDC64011-247
Product TypeHuman Prescription Drug
Proprietary NameMakena
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2011-02-03
Marketing CategoryNDA / NDA
Application NumberNDA021945
Labeler NameAMAG Pharmaceuticals, Inc.
Substance NameHYDROXYPROGESTERONE CAPROATE
Active Ingredient Strength250 mg/mL
Pharm ClassesProgesterone Congeners [CS], Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 64011-247-02

4 CARTON in 1 TRAY (64011-247-02) > 1 VIAL, GLASS in 1 CARTON > 1 mL in 1 VIAL, GLASS
Marketing Start Date2011-02-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64011-247-02 [64011024702]

Makena INJECTION
Marketing CategoryNDA
Application NumberNDA021945
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-02-03

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:a1998c1d-8337-4f00-8dcb-af3b54d39b77
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2000013
  • 2000011
  • 1087968
  • 1087964
  • 1796690
  • 1796692
  • UPC Code
  • 0364011247022
  • 0364011243017
  • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]
    • Progesterone Congeners [CS]
    • Progestin [EPC]

    NDC Crossover Matching brand name "Makena" or generic name "Hydroxyprogesterone Caproate"

    NDCBrand NameGeneric Name
    64011-243Makenahydroxyprogesterone caproate
    64011-247Makenahydroxyprogesterone caproate
    64011-301Makenahydroxyprogesterone caproate
    0517-1767Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    0517-1791Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    47335-037HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATE
    55150-309HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATE
    55150-310HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATE
    55150-311Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    66993-038Hydroxyprogesterone Caproatehydroxyprogesterone caproate
    66993-039Hydroxyprogesterone Caproatehydroxyprogesterone caproate
    67457-886Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    67457-967Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    69238-1797Hydroxyprogesterone CaproateHydroxyprogesterone Caproate
    71225-104HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATE
    71225-105Hydroxyprogesterone caproateHydroxyprogesterone caproate
    73301-001Hydroxyprogesterone CaproateHydroxyprogesterone Caproate

    Trademark Results [Makena]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MAKENA
    MAKENA
    98403041 not registered Live/Pending
    Kylie Dean
    2024-02-13
    MAKENA
    MAKENA
    98403041 not registered Live/Pending
    Michael Dean
    2024-02-13
    MAKENA
    MAKENA
    98057276 not registered Live/Pending
    Jani Organics
    2023-06-24
    MAKENA
    MAKENA
    90263779 not registered Live/Pending
    AMERICAN GIRL, LLC
    2020-10-19
    MAKENA
    MAKENA
    88397549 not registered Live/Pending
    Makena Music LLC
    2019-04-23
    MAKENA
    MAKENA
    88083101 5732340 Live/Registered
    MAKENA CLUB LLC
    2018-08-17
    MAKENA
    MAKENA
    86323275 5023059 Live/Registered
    Makena Electronic (shenzhen) Co.,Ltd.
    2014-06-27
    MAKENA
    MAKENA
    85759791 4452406 Live/Registered
    Watkins Manufacturing Corporation
    2012-10-22
    MAKENA
    MAKENA
    85187580 4046878 Live/Registered
    AMAG PHARMA USA, INC.
    2010-11-30
    MAKENA
    MAKENA
    77968047 not registered Dead/Abandoned
    makena electronic(shenzhen)co.,ltd
    2010-03-25
    MAKENA
    MAKENA
    77472001 not registered Dead/Abandoned
    Keaka LLC
    2008-05-12
    MAKENA
    MAKENA
    77471994 not registered Dead/Abandoned
    Keaka LLC
    2008-05-12

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