HALOPERIDOL DECANOATE
Haloperidol Decanoate Injection For Intramuscular Injection Only
Approved
Approval ID
f2bff27f-929f-4f7d-b3eb-084ebc2a885f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-384
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-382
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-383
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-031
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-030
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70069-381
Application NumberANDA209101
Product Classification
M
Marketing Category
C73584
G
Generic Name
HALOPERIDOL DECANOATE
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT