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FDA Approval

Fexofenadine hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Dr. Reddy's Laboratories Limited
DUNS: 650562841
Effective Date
May 6, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Fexofenadine(30 mg in 1 1)

Manufacturing Establishments3

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Dr. Reddy's Laboratories Limited (FTO III)

Dr. Reddy's Laboratories Limited

918608162

Reed-Lane, Inc.

Dr. Reddy's Laboratories Limited

001819879

DR. REDDY'S LABORATORIES LIMITED

Dr. Reddy's Laboratories Limited

860037244

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fexofenadine hydrochloride

Product Details

NDC Product Code
55111-782
Application Number
ANDA076502
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 6, 2025
FexofenadineActive
Code: 2S068B75ZUClass: ACTIBQuantity: 30 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
polyethylene glycol 400Inactive
Code: B697894SGQClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Fexofenadine hydrochloride

Product Details

NDC Product Code
55111-784
Application Number
ANDA076502
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 6, 2025
FexofenadineActive
Code: 2S068B75ZUClass: ACTIBQuantity: 180 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Fexofenadine hydrochloride

Product Details

NDC Product Code
55111-783
Application Number
ANDA076502
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 6, 2025
FexofenadineActive
Code: 2S068B75ZUClass: ACTIBQuantity: 60 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9MClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
polyethylene glycol 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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Fexofenadine hydrochloride - FDA Approval | MedPath