Haloperidol
HALOPERIDOL TABLETS, USP Rx only
Approved
Approval ID
35573a97-e20d-4509-8178-8c08de3ab33f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
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 Code70518-3440
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
HALOPERIDOLActive
Quantity: 1 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB