Home NDC 63654-380 Fluticasone Propionate
Product NDC 63654-380
11-digit product format 636540380
Labeler code 63654
Product ID 63654-380_9519d5f7-acd5-4700-9738-08cef7e54083
Type HUMAN OTC DRUG
Nonproprietary name Fluticasone Propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler Selder, S.A. de C.V.
Application ANDA208150
Marketing category ANDA
Marketing start 2017-05-17
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 63654-380 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63654-380 63654-380-01 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208150-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2016-02-29 cb3db0bc1861…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63654-380-01 Fluticasone Propionate 120 in 1 BOTTLE, SPRAY SPRAY, METERED 120 7 63654-380-01 Fluticasone Propionate 1 in 1 CARTON SPRAY, METERED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63654-380 FLUTICASONE PROPIONATE SPRAY, METERED [SELDER, S.A. DE C.V.] 7 Current NDC, Legacy NDC, 2 package rows 20231129_2da4ba91-c356-473d-b20c-5bb9265767df.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63654-380-01 63654038001 1 BOTTLE, SPRAY in 1 CARTON (63654-380-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2017-05-17 0000-00-00 No No Current