Haloperidol
HaloperidolTablets, USP0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg and 20 mg
Approved
Approval ID
c559b0b0-4087-d12a-e718-c18ccb6811e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-0214
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (7)
HALOPERIDOLActive
Quantity: 2 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0334
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (8)
HALOPERIDOLActive
Quantity: 10 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0335
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (8)
HALOPERIDOLActive
Quantity: 20 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0327
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (7)
HALOPERIDOLActive
Quantity: 5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0257
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (7)
HALOPERIDOLActive
Quantity: 1 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
haloperidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0351
Application NumberANDA070278
Product Classification
M
Marketing Category
C73584
G
Generic Name
haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2022
FDA Product Classification
INGREDIENTS (7)
HALOPERIDOLActive
Quantity: 0.5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT