Haloperidol
Haloperidol Injection, USP
Approved
Approval ID
a9970612-0ab3-4a8b-ae84-231738d913a4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2021
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code76045-737
Application NumberANDA210356
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol lactate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 30, 2019
FDA Product Classification
INGREDIENTS (2)
Haloperidol lactateActive
Quantity: 5 mg in 1 mL
Code: 6387S86PK3
Classification: ACTIM
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT