Haloperidol
(Concentrate) 2 mg per mLRx only.
Approved
Approval ID
3766e48c-4bd3-448c-a526-06a347ea8f5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2020
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-0501
Application NumberANDA073364
Product Classification
M
Marketing Category
C73584
G
Generic Name
Haloperidol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2020
FDA Product Classification
INGREDIENTS (6)
HALOPERIDOL LACTATEActive
Quantity: 2 mg in 1 mL
Code: 6387S86PK3
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT