NDC 55150-309

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 ID55150-309_4d1b925d-3179-4a37-a48a-440869d599be
NDC55150-309
Product TypeHuman Prescription Drug
Proprietary NameHYDROXYPROGESTERONE CAPROATE
Generic NameHydroxyprogesterone Caproate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2019-04-16
Marketing CategoryANDA / ANDA
Application NumberANDA211071
Labeler NameAuroMedics Pharma 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 55150-309-01

1 VIAL, SINGLE-DOSE in 1 CARTON (55150-309-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-309-01 [55150030901]

HYDROXYPROGESTERONE CAPROATE INJECTION
Marketing CategoryANDA
Application NumberANDA211071
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-16

NDC 55150-309-04 [55150030904]

HYDROXYPROGESTERONE CAPROATE INJECTION
Marketing CategoryANDA
Application NumberANDA211071
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-16

Drug Details

Active Ingredients

IngredientStrength
HYDROXYPROGESTERONE CAPROATE250 mg/mL

OpenFDA Data

SPL SET ID:86f4f8b2-f0a3-47ba-b5cf-97b425d70589
Manufacturer
UNII

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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.