NDC 67457-886

Hydroxyprogesterone Caproate

Hydroxyprogesterone Caproate

Hydroxyprogesterone Caproate is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Hydroxyprogesterone Caproate.

Product ID67457-886_c625a383-79c9-4012-a4b8-395da9142a8c
NDC67457-886
Product TypeHuman Prescription Drug
Proprietary NameHydroxyprogesterone Caproate
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2017-09-22
Marketing CategoryANDA / ANDA
Application NumberANDA200271
Labeler NameMylan Institutional LLC
Substance NameHYDROXYPROGESTERONE CAPROATE
Active Ingredient Strength250 mg/mL
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67457-886-05

1 VIAL, MULTI-DOSE in 1 CARTON (67457-886-05) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2017-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-886-05 [67457088605]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA200271
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-22

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:0919b927-c57c-40ae-88a8-39e9efe4f677
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087964

    • 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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