NDC 67457-967

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 ID67457-967_037ff10a-315c-486a-a0ee-20077cbc254b
NDC67457-967
Product TypeHuman Prescription Drug
Proprietary NameHydroxyprogesterone Caproate
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-08-23
Marketing CategoryANDA / ANDA
Application NumberANDA211777
Labeler NameMylan Institutional LLC
Substance NameHYDROXYPROGESTERONE CAPROATE
Active Ingredient Strength250 mg/mL
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-967-01

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-967-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-08-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-967-01 [67457096701]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA211777
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-23

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:037ff10a-315c-486a-a0ee-20077cbc254b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1796690

    • Pharmacological Class

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