Clomiphene Citrate
Clomiphene Citrate Tablets
Approved
Approval ID
be399623-6400-475d-93d3-1dedd4d43017
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2021
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clomiphene Citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-701
Application NumberANDA075528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clomiphene Citrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2022
FDA Product Classification
INGREDIENTS (5)
CLOMIPHENE CITRATEActive
Quantity: 50 mg in 1 1
Code: 1B8447E7YI
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT