Karbinal
These highlights do not include all the information needed to use KARBINAL ER safely and effectively. See full prescribing information for KARBINAL ER. Karbinal ER (carbinoxamine maleate) extended-release oral suspension Initial U.S. Approval: 1953
Approved
Approval ID
c40b3f4e-2d71-41a1-a1fc-f64f38724879
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2023
Manufacturers
FDA
Aytu Therapeutics, LLC
DUNS: 117244733
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carbinoxamine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23594-101
Application NumberNDA022556
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carbinoxamine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2023
FDA Product Classification
INGREDIENTS (14)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CARBINOXAMINE MALEATEActive
Quantity: 4 mg in 5 mL
Code: 02O55696WH
Classification: ACTIB