Haloperidol
Haloperidol Tablets, USP 8224901/0819 Rx only
Approved
Approval ID
d62617da-c8ad-45da-8915-c59edc5558a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
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 Code60687-161
Application NumberANDA077580
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (8)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HALOPERIDOLActive
Quantity: 5 mg in 1 1
Code: J6292F8L3D
Classification: ACTIB