fexofenadine hydrochloride

Generic: fexofenadine hydrochloride

Labeler: cvs pharmacy, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hydrochloride
Generic Name fexofenadine hydrochloride
Labeler cvs pharmacy, inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
CVS PHARMACY, INC

Identifiers & Regulatory

Product NDC 51316-800
Product ID 51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091567
Listing Expiration 2026-12-31
Marketing Start 2022-09-20

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 51316800
Hyphenated Format 51316-800

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 hydrochloride (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA091567 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (51316-800-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (6)

51316-800-08 1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE 51316-800-15 1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK 51316-800-30 1 BOTTLE in 1 CARTON (51316-800-30) / 30 TABLET in 1 BOTTLE 51316-800-45 1 BOTTLE in 1 CARTON (51316-800-45) / 45 TABLET in 1 BOTTLE 51316-800-70 1 BOTTLE in 1 CARTON (51316-800-70) / 70 TABLET in 1 BOTTLE 51316-800-90 1 BOTTLE in 1 CARTON (51316-800-90) / 90 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": "e6bae65e-9f41-4976-bebd-c14e86da14cb", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["7bc13851-291a-4582-8261-13c5022fbdd1"], "manufacturer_name": ["CVS PHARMACY, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-800-08)  / 180 TABLET in 1 BOTTLE", "package_ndc": "51316-800-08", "marketing_start_date": "20220920"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51316-800-15)  / 15 TABLET in 1 BLISTER PACK", "package_ndc": "51316-800-15", "marketing_start_date": "20220920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-800-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "51316-800-30", "marketing_start_date": "20220920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-800-45)  / 45 TABLET in 1 BOTTLE", "package_ndc": "51316-800-45", "marketing_start_date": "20220920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-800-70)  / 70 TABLET in 1 BOTTLE", "package_ndc": "51316-800-70", "marketing_start_date": "20220920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-800-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "51316-800-90", "marketing_start_date": "20220920"}], "brand_name": "FEXOFENADINE HYDROCHLORIDE", "product_id": "51316-800_e6bae65e-9f41-4976-bebd-c14e86da14cb", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51316-800", "generic_name": "FEXOFENADINE HYDROCHLORIDE", "labeler_name": "CVS PHARMACY, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FEXOFENADINE HYDROCHLORIDE", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA091567", "marketing_category": "ANDA", "marketing_start_date": "20220920", "listing_expiration_date": "20261231"}