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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9515
Application NumberANDA208197
Product Classification
M
Marketing Category
C73584
G
Generic Name
DROPERIDOL
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 8, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9514
Application NumberANDA208197
Product Classification
M
Marketing Category
C73584
G
Generic Name
DROPERIDOL
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJune 8, 2022
FDA Product Classification
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