Haloperidol
Haloperidol Tablets, USP
Approved
Approval ID
f20769bc-98a3-419a-ba36-2e9737050cd9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-9274
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2019
FDA Product Classification
INGREDIENTS (5)
HALOPERIDOLActive
Quantity: 5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT