Haloperidol decanoate
Haloperidol Decanoate InjectionFor Intramuscular Injection Only
Approved
Approval ID
d21796e5-9f29-4c0a-8eed-70aeb9f0e5e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 4
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 Code70771-1852
Application NumberANDA211180
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (3)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
Haloperidol decanoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1853
Application NumberANDA211180
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Haloperidol decanoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1851
Application NumberANDA211180
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (3)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
Haloperidol decanoate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1854
Application NumberANDA211180
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (3)
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM