NDC 55150-311

Hydroxyprogesterone Caproate

Hydroxyprogesterone Caproate

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

Product ID55150-311_31fe711c-6a9c-49e9-8f08-ee536562f44e
NDC55150-311
Product TypeHuman Prescription Drug
Proprietary NameHydroxyprogesterone Caproate
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-05-09
Marketing CategoryANDA / ANDA
Application NumberANDA211142
Labeler NameAuroMedics Pharma LLC
Substance NameHYDROXYPROGESTERONE CAPROATE
Active Ingredient Strength1250 mg/5mL
Pharm ClassesProgesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55150-311-01

1 VIAL in 1 CARTON (55150-311-01) > 5 mL in 1 VIAL
Marketing Start Date2019-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-311-05 [55150031105]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA211142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-09

NDC 55150-311-01 [55150031101]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA211142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-09

NDC 55150-311-00 [55150031100]

Hydroxyprogesterone Caproate INJECTION
Marketing CategoryANDA
Application NumberANDA211142
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-09
Marketing End Date2019-10-09

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE1250 mg/5mL

OpenFDA Data

SPL SET ID:687bcf42-f437-42c7-8909-a91f621f55df
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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