Ovidrel
OVIDREL PreFilled Syringe(choriogonadotropin alfa injection)
Approved
Approval ID
a683e58a-63ea-44b8-a326-1a99a537bcf2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
EMD Serono, Inc.
DUNS: 088514898
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
choriogonadotropin alfa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44087-1150
Application NumberBLA021149
Product Classification
M
Marketing Category
C73585
G
Generic Name
choriogonadotropin alfa
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (7)
CHORIOGONADOTROPIN ALFAActive
Quantity: 250 ug in 0.5 mL
Code: 6413W06WR3
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METHIONINEInactive
Code: AE28F7PNPL
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT