Fexofenadine Hydrochloride
Fexofenadine HCl Tablets USP
Approved
Approval ID
b0121213-eae1-8429-9986-3b3b26f35e47
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Dr. Reddy's Laboratories Inc.
DUNS: 802315887
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fexofenadine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-936
Application NumberANDA076502
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fexofenadine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (12)
Fexofenadine HydrochlorideActive
Quantity: 60 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
polyethylene glycol 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT