Haloperidol Decanoate
Haloperidol Decanoate Injection (For Intramuscular Injection Only) Rx only
Approved
Approval ID
1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2023
Manufacturers
FDA
Gland Pharma Limited
DUNS: 918601238
Products 2
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 Code68083-137
Application NumberANDA205241
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol Decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 4, 2023
FDA Product Classification
INGREDIENTS (3)
HALOPERIDOL DECANOATEActive
Quantity: 50 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
BENZYL ALCOHOLInactive
Quantity: 12 mg in 1 mL
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 Code68083-138
Application NumberANDA205241
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol Decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 4, 2023
FDA Product Classification
INGREDIENTS (3)
BENZYL ALCOHOLInactive
Quantity: 12 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
HALOPERIDOL DECANOATEActive
Quantity: 100 mg in 1 mL
Code: AC20PJ4101
Classification: ACTIM
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT