Droperidol
DROPERIDOL INJECTION, USP
Approved
Approval ID
147e033d-d997-4ef6-8bb5-a9ba372590b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2023
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Droperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-9702
Application NumberANDA072123
Product Classification
M
Marketing Category
C73584
G
Generic Name
Droperidol
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 20, 2023
FDA Product Classification
INGREDIENTS (4)
DROPERIDOLActive
Quantity: 2.5 mg in 1 mL
Code: O9U0F09D5X
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT