Hydroxyprogesterone Caproate
These highlights do not include all the information needed to use HYDROXYPROGESTERONE CAPROATE INJECTION safely and effectively. See full prescribing information for HYDROXYPROGESTERONE CAPROATE INJECTION. HYDROXYPROGESTERONE CAPROATE injection, for intramuscular use. Initial U.S. Approval: 1956
Approved
Approval ID
79cd136b-2098-43a4-aeec-7d8b8869f6ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2018
Manufacturers
FDA
Amneal Pharmaceuticals of NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydroxyprogesterone Caproate
PRODUCT DETAILS
NDC Product Code69238-1797
Application NumberANDA210723
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 1, 2018
Generic NameHydroxyprogesterone Caproate
INGREDIENTS (3)
HYDROXYPROGESTERONE CAPROATEActive
Quantity: 250 mg in 1 mL
Code: 276F2O42F5
Classification: ACTIB
CASTOR OILInactive
Quantity: 294 mg in 1 mL
Code: D5340Y2I9G
Classification: IACT
BENZYL BENZOATEInactive
Quantity: 514.3 mg in 1 mL
Code: N863NB338G
Classification: IACT