Home NDC 55681-389-14 Fluticasone Propionate
Product NDC 55681-389
Requested package NDC 55681-389-14
11-digit product format 556810389
Labeler code 55681
Product ID 55681-389_35b785eb-acff-cbf4-e063-6294a90a8a60
Type HUMAN OTC DRUG
Nonproprietary name Fluticasone Propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler TWIN MED LLC
Application ANDA208150
Marketing category ANDA
Marketing start 2025-05-01
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208150-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 2 · 21 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Fluticasone Propionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUTICASONE PROPIONATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O2GMZ0LF5W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797907 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55681-389-14 Fluticasone Propionate 1 in 1 CARTON SPRAY, METERED 1 1 55681-389-14 Fluticasone Propionate 144 in 1 BOTTLE, SPRAY SPRAY, METERED 144 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55681-389 FLUTICASONE PROPIONATE SPRAY, METERED [TWIN MED LLC] 1 Current NDC, 2 package rows 20250523_9337aa4b-382d-4ab9-b312-60417cdd40cf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55681-389-14 55681038914 1 BOTTLE, SPRAY in 1 CARTON (55681-389-14) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY 2025-05-01 No No Current