topcare fluticasone propionate nasal

Generic: fluticasone propionate

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

Drug Facts

Product Profile

Brand Name topcare fluticasone propionate nasal
Generic Name fluticasone propionate
Labeler topco associates llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

fluticasone propionate 50 ug/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-222
Product ID 36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207957
Listing Expiration 2026-12-31
Marketing Start 2016-06-24

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800222
Hyphenated Format 36800-222

Supplemental Identifiers

RxCUI
1797907
UNII
O2GMZ0LF5W

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 fluticasone propionate nasal (source: ndc)
Generic Name fluticasone propionate (source: ndc)
Application Number ANDA207957 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE
source: ndc

Packages (4)

36800-222-01 1 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE 36800-222-03 2 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE 36800-222-09 1 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE 36800-222-10 2 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE

Ingredients (1)

fluticasone propionate (50 ug/1)

Linked Drug Pages (1)

topcare fluticasone propionate nasal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "343d4087-6c6d-430a-a927-d1c0cedf420e", "openfda": {"unii": ["O2GMZ0LF5W"], "rxcui": ["1797907"], "spl_set_id": ["f7c425d2-4afb-478f-83bc-eb336910233b"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-222-01)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "36800-222-01", "marketing_start_date": "20160624"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (36800-222-03)  / 120 SPRAY, METERED in 1 BOTTLE", "package_ndc": "36800-222-03", "marketing_start_date": "20171019"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-222-09)  / 144 SPRAY, METERED in 1 BOTTLE", "package_ndc": "36800-222-09", "marketing_start_date": "20210526"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (36800-222-10)  / 144 SPRAY, METERED in 1 BOTTLE", "package_ndc": "36800-222-10", "marketing_start_date": "20210526"}], "brand_name": "topcare fluticasone propionate nasal", "product_id": "36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "36800-222", "generic_name": "Fluticasone propionate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare fluticasone propionate nasal", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "50 ug/1"}], "application_number": "ANDA207957", "marketing_category": "ANDA", "marketing_start_date": "20160624", "listing_expiration_date": "20261231"}