Haloperidol
Haloperidol Injection, USP
Approved
Approval ID
e2eed126-cb82-42b1-9b48-9cbeb6873b50
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HALOPERIDOL LACTATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-9553
Application NumberANDA075689
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL LACTATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 27, 2020
FDA Product Classification
INGREDIENTS (4)
HALOPERIDOL LACTATEActive
Quantity: 5 mg in 1 mL
Code: 6387S86PK3
Classification: ACTIM
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT