Haloperidol Lactate
Haloperidol Injection, USP (For Immediate Release) Rx only
Approved
Approval ID
65df5d2d-79aa-41d4-866a-566e520320f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9871
Application NumberANDA078347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 11, 2022
FDA Product Classification
INGREDIENTS (5)
HALOPERIDOL LACTATEActive
Quantity: 5 mg in 1 mL
Code: 6387S86PK3
Classification: ACTIM
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT