NDC 47335-037

HYDROXYPROGESTERONE CAPROATE

Hydroxyprogesterone Caproate

HYDROXYPROGESTERONE CAPROATE is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Hydroxyprogesterone Caproate.

Product ID47335-037_dd6cda1c-d74f-4cc0-8027-bc2af7c1b1f6
NDC47335-037
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYPROGESTERONE CAPROATE
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA208381
Labeler NameSun Pharmaceutical Industries, 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 47335-037-40

1 VIAL, MULTI-DOSE in 1 CARTON (47335-037-40) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-037-40 [47335003740]

HYDROXYPROGESTERONE CAPROATE INJECTION
Marketing CategoryANDA
Application NumberANDA208381
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:458ed273-ef9c-4351-8bc2-173c3059d107
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087964

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.