Haloperidol
HALOPERIDOL TABLETS, USP Rx only
Approved
Approval ID
2c26af24-5ed3-4eb7-8d29-d6a019320a70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Innogenix, Inc.
DUNS: 080501434
Products 6
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 Code71247-155
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (5)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HALOPERIDOLActive
Quantity: 20 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71247-154
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HALOPERIDOLActive
Quantity: 10 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71247-152
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (4)
HALOPERIDOLActive
Quantity: 2 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71247-150
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (4)
HALOPERIDOLActive
Quantity: 0.5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71247-151
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (5)
HALOPERIDOLActive
Quantity: 1 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
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
Haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71247-153
Application NumberANDA071173
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2021
FDA Product Classification
INGREDIENTS (6)
HALOPERIDOLActive
Quantity: 5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
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
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT