Home NDC 50090-3513 Fluticasone Propionate
Product NDC 50090-3513
11-digit product format 500903513
Labeler code 50090
Product ID 50090-3513_ac1f6ca4-6247-4a09-8fc6-a8e1e9287a2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fluticasone Propionate
Dosage form SPRAY, METERED
Route NASAL
Labeler A-S Medication Solutions
Application ANDA077570
Marketing category ANDA
Marketing start 2008-01-16
Marketing end 0000-00-00
Substance FLUTICASONE PROPIONATE
Active strength 50 ug/.1g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-3513-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-3513-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-3513-0 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-3513-0 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-3513-0 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-3513-0 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-3513-0 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077570-001 FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16
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 · 42 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 2026-08-18 06:07:40 2026-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2008-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077570-001 FLUTICASONE PROPIONATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2008-01-16 e64feba35796…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-3513-0 2024-10-23 C162847 48780-1 f386c649-ec76-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Fluticasone Propionate Nasal Spray, USP safely and effectively. See full prescribing information for Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate nasal spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994 50090-3513-0 2023-01-30 C162847 48780-1 f386c649-ec76-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use Fluticasone Propionate Nasal Spray, USP safely and effectively. See full prescribing information for Fluticasone Propionate Nasal Spray, USP. Fluticasone Propionate nasal spray, USP, 50 mcg FOR INTRANASAL USE Initial U.S. Approval: 1994
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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-3513-0 50090351300 1 BOTTLE, PUMP in 1 CARTON (50090-3513-0) > 16 g in 1 BOTTLE, PUMP 2018-07-26 0000-00-00 No No Current