fexofenadine hcl

Generic: fexofenadine hcl

Labeler: granules pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler granules pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
GRANULES PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 70010-183
Product ID 70010-183_451e21a2-6057-7a94-e063-6294a90a9f87
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211075
Listing Expiration 2026-12-31
Marketing Start 2023-04-25

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 70010183
Hyphenated Format 70010-183

Supplemental Identifiers

RxCUI
997420
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 hcl (source: ndc)
Generic Name fexofenadine hcl (source: ndc)
Application Number ANDA211075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (70010-183-03)
source: ndc

Packages (1)

70010-183-03 30 TABLET in 1 BOTTLE (70010-183-03)

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

Fexofenadine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "451e21a2-6057-7a94-e063-6294a90a9f87", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["fa30c8ce-ad9d-b6fe-e053-6294a90a2443"], "manufacturer_name": ["GRANULES PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (70010-183-03)", "package_ndc": "70010-183-03", "marketing_start_date": "20230425"}], "brand_name": "Fexofenadine HCL", "product_id": "70010-183_451e21a2-6057-7a94-e063-6294a90a9f87", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "70010-183", "generic_name": "Fexofenadine HCL", "labeler_name": "GRANULES PHARMACEUTICALS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCL", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA211075", "marketing_category": "ANDA", "marketing_start_date": "20230425", "listing_expiration_date": "20261231"}