fexofenadine hcl

Generic: fexofenadine hcl

Labeler: northstar rxllc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fexofenadine hcl
Generic Name fexofenadine hcl
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 16714-899
Product ID 16714-899_2d00700d-63a2-4a45-b607-028a883fe10a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204097
Listing Expiration 2026-12-31
Marketing Start 2019-02-18

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 16714899
Hyphenated Format 16714-899

Supplemental Identifiers

RxCUI
997420
UPC
0316714899022 0316714899015
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 ANDA204097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (2)

16714-899-01 1 BOTTLE in 1 CARTON (16714-899-01) / 30 TABLET in 1 BOTTLE 16714-899-02 1 BOTTLE in 1 CARTON (16714-899-02) / 100 TABLET in 1 BOTTLE

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": "2d00700d-63a2-4a45-b607-028a883fe10a", "openfda": {"upc": ["0316714899022", "0316714899015"], "unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["9c308a91-640d-441b-8fb5-acb5a415405e"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (16714-899-01)  / 30 TABLET in 1 BOTTLE", "package_ndc": "16714-899-01", "marketing_start_date": "20190218"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (16714-899-02)  / 100 TABLET in 1 BOTTLE", "package_ndc": "16714-899-02", "marketing_start_date": "20190218"}], "brand_name": "Fexofenadine HCL", "product_id": "16714-899_2d00700d-63a2-4a45-b607-028a883fe10a", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "16714-899", "generic_name": "Fexofenadine HCL", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fexofenadine HCL", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA204097", "marketing_category": "ANDA", "marketing_start_date": "20190218", "listing_expiration_date": "20261231"}