fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-6711
Product ID 0904-6711_dad01df2-a6b4-5fac-8c6a-d49c1166892f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076502
Marketing Start 2018-04-27
Marketing End 2026-08-31

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 09046711
Hyphenated Format 0904-6711

Supplemental Identifiers

RxCUI
997420
UNII
2S068B75ZU

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
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-6711-46) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0904-6711-46 1 BOTTLE in 1 CARTON (0904-6711-46) / 30 TABLET in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (180 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": "dad01df2-a6b4-5fac-8c6a-d49c1166892f", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["0a6da401-a8a3-5d0b-f37e-c220838f7e49"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6711-46)  / 30 TABLET in 1 BOTTLE", "package_ndc": "0904-6711-46", "marketing_end_date": "20260831", "marketing_start_date": "20180427"}], "brand_name": "Fexofenadine hydrochloride", "product_id": "0904-6711_dad01df2-a6b4-5fac-8c6a-d49c1166892f", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-6711", "generic_name": "Fexofenadine hydrochloride", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine hydrochloride", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA076502", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20180427"}