Clomiphene Citrate
70025264 Clomiphene Citrate Tablets USP Revised: November 2012 Rx only
Approved
Approval ID
8b10aaa1-fcf8-42c5-9b5a-1ac6bc417bdf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 2018
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0677
Application NumberNDA016131
Product Classification
M
Marketing Category
C73605
G
Generic Name
Clomiphene Citrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2018
FDA Product Classification
INGREDIENTS (5)
CLOMIPHENE CITRATEActive
Quantity: 50 mg in 1 1
Code: 1B8447E7YI
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT