fluticasone propionate

Generic: fluticasone propionate

Labeler: twin med llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluticasone propionate
Generic Name fluticasone propionate
Labeler twin med llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

fluticasone propionate 50 ug/1

Manufacturer
TWIN MED LLC

Identifiers & Regulatory

Product NDC 55681-389
Product ID 55681-389_35b785eb-acff-cbf4-e063-6294a90a8a60
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA208150
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55681389
Hyphenated Format 55681-389

Supplemental Identifiers

RxCUI
1797907
UPC
0816516013737
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 (55681-389-14) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

55681-389-14 1 BOTTLE, SPRAY in 1 CARTON (55681-389-14) / 144 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": "35b785eb-acff-cbf4-e063-6294a90a8a60", "openfda": {"upc": ["0816516013737"], "unii": ["O2GMZ0LF5W"], "rxcui": ["1797907"], "spl_set_id": ["9337aa4b-382d-4ab9-b312-60417cdd40cf"], "manufacturer_name": ["TWIN MED LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (55681-389-14)  / 144 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "55681-389-14", "marketing_start_date": "20250501"}], "brand_name": "Fluticasone Propionate", "product_id": "55681-389_35b785eb-acff-cbf4-e063-6294a90a8a60", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "55681-389", "generic_name": "Fluticasone Propionate", "labeler_name": "TWIN MED LLC", "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": "20250501", "listing_expiration_date": "20261231"}