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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

NDC Product Code0517-9702
Application NumberANDA072123
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 20, 2023
Generic NameDroperidol

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

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Droperidol - FDA Drug Approval Details