Fluticasone propionate

Product NDC
50383-968
11-digit product format
503830968
Labeler code
50383
Product ID
50383-968_ad35d691-3574-49cf-898c-b1cbd0c8f7bb
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Akorn
Application
ANDA208024
Marketing category
ANDA
Marketing start
2019-04-18
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-968DDiscontinued by firm2026-08-03
excluded packagepackage50383-96850383-968-16DDiscontinued by firm2026-08-03
excluded packagepackage50383-96850383-968-18DDiscontinued by firm2026-08-03
excluded packagepackage50383-96850383-968-36DDiscontinued by firm2026-08-03
excluded packagepackage50383-96850383-968-37DDiscontinued by firm2026-08-03
excluded packagepackage50383-96850383-968-38DDiscontinued by firm2026-08-03

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 2 · 90 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-968-38DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-968-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-968-37DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-968-36DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-968-18DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-968-18IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-968-16IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-968-38IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-968-37IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-968-36IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-968-18IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-968-16IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-968-38IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-968-37IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-968-36IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-968-18IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-968-16IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-968-38IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-968-37IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-968-36IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-968-18IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-968-16IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-968-38IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-968-37IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-968-36IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-968-18IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-968-16IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-968-38IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-968-37IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-968-36IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-968-18IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-968-16IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-968-38IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-968-37IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-968-36IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-968-18IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-968-16IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-968-38IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-968-37IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-968-36IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-968-18IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-968-16IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-968-38IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-968-37IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-968-36IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-968-18IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-968-16IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-968-38IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-968-37IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-968-36IInactivated by FDAad56d346431e…cc804d4bbf1e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208024-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50383-968-162025-09-10Drug Facts
50383-968-182025-09-10Drug Facts
50383-968-362025-09-10Drug Facts
50383-968-372025-09-10Drug Facts
50383-968-382025-09-10Drug Facts
50383-968-162024-01-30Drug Facts
50383-968-182024-01-30Drug Facts
50383-968-362024-01-30Drug Facts
50383-968-372024-01-30Drug Facts
50383-968-382024-01-30Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-968FLUTICASONE PROPIONATE SPRAY, METERED [AKORN]9Legacy NDC20220309_a778d891-b9e9-47d7-b474-4baca8be1dbd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-968-16503830968161 BOTTLE, PUMP in 1 CARTON (50383-968-16) > 120 SPRAY, METERED in 1 BOTTLE, PUMP2019-04-180000-00-00NoNoCurrent
50383-968-18503830968181 BOTTLE, PUMP in 1 CARTON (50383-968-18) > 60 SPRAY, METERED in 1 BOTTLE, PUMP2019-04-180000-00-00NoNoCurrent
50383-968-36503830968362 BOTTLE, PUMP in 1 CARTON (50383-968-36) > 60 SPRAY, METERED in 1 BOTTLE, PUMP2019-04-180000-00-00NoNoCurrent
50383-968-37503830968372 BOTTLE, PUMP in 1 CARTON (50383-968-37) > 120 SPRAY, METERED in 1 BOTTLE, PUMP2019-04-180000-00-00NoNoCurrent
50383-968-38503830968383 BOTTLE, PUMP in 1 CARTON (50383-968-38) > 120 SPRAY, METERED in 1 BOTTLE, PUMP2019-04-180000-00-00NoNoCurrent