Hydroxyprogesterone Caproate
Approved
Approval ID
0919b927-c57c-40ae-88a8-39e9efe4f677
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-886
Application NumberANDA200271
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydroxyprogesterone Caproate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 15, 2021
FDA Product Classification
INGREDIENTS (4)
HYDROXYPROGESTERONE CAPROATEActive
Quantity: 250 mg in 1 mL
Code: 276F2O42F5
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT