fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler dr. reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 30 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-782
Product ID 55111-782_9c0b82c6-7eff-3eec-40e2-db72a8625eff
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076502
Listing Expiration 2026-12-31
Marketing Start 2011-01-03

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111782
Hyphenated Format 55111-782

Supplemental Identifiers

RxCUI
997420 997488 997501
UNII
2S068B75ZU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fexofenadine hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA076502 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (55111-782-01)
  • 30 TABLET in 1 BOTTLE (55111-782-30)
  • 10 BLISTER PACK in 1 CARTON (55111-782-78) / 10 TABLET in 1 BLISTER PACK (55111-782-79)
  • 90 TABLET in 1 BOTTLE (55111-782-90)
source: ndc

Packages (4)

55111-782-01 100 TABLET in 1 BOTTLE (55111-782-01) 55111-782-30 30 TABLET in 1 BOTTLE (55111-782-30) 55111-782-78 10 BLISTER PACK in 1 CARTON (55111-782-78) / 10 TABLET in 1 BLISTER PACK (55111-782-79) 55111-782-90 90 TABLET in 1 BOTTLE (55111-782-90)

Ingredients (1)

fexofenadine hydrochloride (30 mg/1)

Linked Drug Pages (1)

Fexofenadine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c0b82c6-7eff-3eec-40e2-db72a8625eff", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420", "997488", "997501"], "spl_set_id": ["864e3052-5787-bf11-9d17-11274ca2304f"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55111-782-01)", "package_ndc": "55111-782-01", "marketing_start_date": "20110103"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (55111-782-30)", "package_ndc": "55111-782-30", "marketing_start_date": "20110103"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-782-78)  / 10 TABLET in 1 BLISTER PACK (55111-782-79)", "package_ndc": "55111-782-78", "marketing_start_date": "20110103"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (55111-782-90)", "package_ndc": "55111-782-90", "marketing_start_date": "20110103"}], "brand_name": "Fexofenadine hydrochloride", "product_id": "55111-782_9c0b82c6-7eff-3eec-40e2-db72a8625eff", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "55111-782", "generic_name": "Fexofenadine hydrochloride", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA076502", "marketing_category": "ANDA", "marketing_start_date": "20110103", "listing_expiration_date": "20261231"}