NDC 0517-1791

Hydroxyprogesterone Caproate

Hydroxyprogesterone Caproate

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

Product ID0517-1791_6d1f43e5-64c0-46bf-aea7-0b4c529dc5d9
NDC0517-1791
Product TypeHuman Prescription Drug
Proprietary NameHydroxyprogesterone Caproate
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA210723
Labeler NameAmerican Regent, Inc.
Substance NameHYDROXYPROGESTERONE CAPROATE
Active Ingredient Strength250 mg/mL
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0517-1791-01

1 VIAL in 1 BOX (0517-1791-01) > 1 mL in 1 VIAL
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-1791-01 [00517179101]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA210723
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:e75abf24-efa6-4008-a576-80ed92968197
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796690

    • Pharmacological Class

    • Progesterone Congeners [CS]
    • Progestin [EPC]

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

    NDCBrand NameGeneric Name
    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
    64011-243Makenahydroxyprogesterone caproate
    64011-247Makenahydroxyprogesterone caproate
    64011-301Makenahydroxyprogesterone caproate
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