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DROPERIDOL

Droperidol Injection, USP

Approved
Approval ID

d89f33ac-8a6e-49e7-94fb-84e58aad65a8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2022

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 001230762

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

DROPERIDOL

PRODUCT DETAILS

NDC Product Code0143-9515
Application NumberANDA208197
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 8, 2022
Generic NameDROPERIDOL

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
DROPERIDOLActive
Quantity: 2.5 mg in 1 mL
Code: O9U0F09D5X
Classification: ACTIB
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT

DROPERIDOL

PRODUCT DETAILS

NDC Product Code0143-9514
Application NumberANDA208197
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 8, 2022
Generic NameDROPERIDOL

INGREDIENTS (3)

DROPERIDOLActive
Quantity: 2.5 mg in 1 mL
Code: O9U0F09D5X
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
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DROPERIDOL - FDA Approval | MedPath