Haloperidol
HALOPERIDOL INJECTION USP (For Immediate Release)
Approved
Approval ID
8397a841-f240-4767-9dcd-781e6d3f7c7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
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.
Haloperidol Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9502
Application NumberANDA075858
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol Lactate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (4)
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
HALOPERIDOL LACTATEActive
Quantity: 5 mg in 1 mL
Code: 6387S86PK3
Classification: ACTIM
PROPYLPARABENInactive
Quantity: .2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
Haloperidol lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9501
Application NumberANDA075858
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol lactate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 16, 2023
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 ACIDInactive
Code: 33X04XA5AT
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT