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
458ed273-ef9c-4351-8bc2-173c3059d107
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-037
Application NumberANDA208381
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROXYPROGESTERONE CAPROATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 18, 2019
FDA Product Classification
INGREDIENTS (4)
HYDROXYPROGESTERONE CAPROATEActive
Quantity: 250 mg in 1 mL
Code: 276F2O42F5
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT