Estradiol valerate
ESTRADIOL VALERATE INJECTION, USP
Approved
Approval ID
2e5c7559-7420-168d-6272-92bb4d20035d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2022
Manufacturers
FDA
Xiromed, LLC
DUNS: 080228637
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ESTRADIOL VALERATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-273
Application NumberANDA216656
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESTRADIOL VALERATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2021
FDA Product Classification
INGREDIENTS (3)
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT
ESTRADIOL VALERATEActive
Quantity: 10 mg in 1 mL
Code: OKG364O896
Classification: ACTIB
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
ESTRADIOL VALERATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-274
Application NumberANDA216656
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESTRADIOL VALERATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2021
FDA Product Classification
INGREDIENTS (4)
ESTRADIOL VALERATEActive
Quantity: 20 mg in 1 mL
Code: OKG364O896
Classification: ACTIB
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
ESTRADIOL VALERATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-275
Application NumberANDA216656
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESTRADIOL VALERATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2021
FDA Product Classification
INGREDIENTS (4)
ESTRADIOL VALERATEActive
Quantity: 40 mg in 1 mL
Code: OKG364O896
Classification: ACTIB
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT