Haloperidol Decanoate
HALOPERIDOL DECANOATE 50 HALOPERIDOL DECANOATE 100 For IM Injection Only
Approved
Approval ID
9f0f42a8-5f7c-4be7-93ef-3ec225502cc6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2020
Manufacturers
FDA
Patriot Pharmaceuticals LLC
DUNS: 178220385
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 Code10147-0921
Application NumberNDA018701
Product Classification
M
Marketing Category
C73605
G
Generic Name
Haloperidol Decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 10, 2020
FDA Product Classification
INGREDIENTS (3)
Haloperidol DecanoateActive
Quantity: 50 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 Code10147-0922
Application NumberNDA018701
Product Classification
M
Marketing Category
C73605
G
Generic Name
Haloperidol Decanoate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateDecember 10, 2020
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