fluticasone propionate

Generic: fluticasone propionate

Labeler: selder, s.a. de c.v.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate
Generic Name fluticasone propionate
Labeler selder, s.a. de c.v.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

fluticasone propionate 50 ug/1

Manufacturer
Selder, S.A. de C.V.

Identifiers & Regulatory

Product NDC 63654-380
Product ID 63654-380_9519d5f7-acd5-4700-9738-08cef7e54083
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208150
Listing Expiration 2026-12-31
Marketing Start 2017-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63654380
Hyphenated Format 63654-380

Supplemental Identifiers

RxCUI
1797907
UPC
0645981000320
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 fluticasone propionate (source: ndc)
Generic Name fluticasone propionate (source: ndc)
Application Number ANDA208150 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (63654-380-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

63654-380-01 1 BOTTLE, SPRAY in 1 CARTON (63654-380-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

fluticasone propionate (50 ug/1)

Linked Drug Pages (1)

Fluticasone Propionate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "9519d5f7-acd5-4700-9738-08cef7e54083", "openfda": {"upc": ["0645981000320"], "unii": ["O2GMZ0LF5W"], "rxcui": ["1797907"], "spl_set_id": ["2da4ba91-c356-473d-b20c-5bb9265767df"], "manufacturer_name": ["Selder, S.A. de C.V."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (63654-380-01)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "63654-380-01", "marketing_start_date": "20170517"}], "brand_name": "Fluticasone Propionate", "product_id": "63654-380_9519d5f7-acd5-4700-9738-08cef7e54083", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63654-380", "generic_name": "Fluticasone Propionate", "labeler_name": "Selder, S.A. de C.V.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Fluticasone Propionate", "active_ingredients": [{"name": "FLUTICASONE PROPIONATE", "strength": "50 ug/1"}], "application_number": "ANDA208150", "marketing_category": "ANDA", "marketing_start_date": "20170517", "listing_expiration_date": "20261231"}