topcare allergy relief

Generic: fexofenadine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare allergy relief
Generic Name fexofenadine hydrochloride
Labeler topco associates llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-691
Product ID 36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212971
Listing Expiration 2026-12-31
Marketing Start 2021-08-23

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 36800691
Hyphenated Format 36800-691

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 topcare allergy relief (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA212971 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-691-39) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-691-49) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-691-75) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

36800-691-39 1 BOTTLE in 1 CARTON (36800-691-39) / 30 TABLET, FILM COATED in 1 BOTTLE 36800-691-49 1 BOTTLE in 1 CARTON (36800-691-49) / 40 TABLET, FILM COATED in 1 BOTTLE 36800-691-75 1 BOTTLE in 1 CARTON (36800-691-75) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

topcare allergy relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9cb64047-5e7e-4fbc-913a-e3831cf557f4", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["e7658b5f-2d78-4f25-b1a3-e49198ca8f32"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-691-39)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-691-39", "marketing_start_date": "20210823"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-691-49)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-691-49", "marketing_start_date": "20210921"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-691-75)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-691-75", "marketing_start_date": "20210921"}], "brand_name": "topcare allergy relief", "product_id": "36800-691_9cb64047-5e7e-4fbc-913a-e3831cf557f4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-691", "generic_name": "fexofenadine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare allergy relief", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA212971", "marketing_category": "ANDA", "marketing_start_date": "20210823", "listing_expiration_date": "20261231"}