Fluticasone Propionate

Product NDC
50383-700
11-digit product format
503830700
Labeler code
50383
Product ID
50383-700_4f61c3c9-e855-4c87-a257-ed2860c866e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Akorn
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 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-700DDiscontinued by firm2026-08-17
excluded packagepackage50383-70050383-700-09DDiscontinued by firm2026-08-17
excluded packagepackage50383-70050383-700-16DDiscontinued by firm2026-08-17

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 · 45 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 packagepackage50383-700-16DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-700-09DDiscontinued 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 packagepackage50383-700-16IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-700-09IInactivated 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 packagepackage50383-700-16IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-700-09IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-700-16IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-700-09IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-700-16IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-700-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50383-700-16IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50383-700-09IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50383-700-16IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50383-700-09IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50383-700-16IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50383-700-09IInactivated by FDA1332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077570-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2008-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-163f01610625f2…
2019-09-15 20:21 UTC2019-09A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077570-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2008-01-16e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077570-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077570-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077570-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077570-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077570-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077570-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077570-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077570-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077570-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077570-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077570-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077570-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077570-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077570-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077570-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077570-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077570-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077570-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077570-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077570-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077570-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077570-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077570-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077570-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077570-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077570-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-700-16GM - Gram50383-700044f5ac8-38f6-4ecd-85ec-913f0e660cb112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [HI-TECH PHARMACAL CO., INC.]6
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [UNIT DOSE SERVICES]2
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE SPRAY, METERED [DIRECT RX]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE SPRAY, METERED [DIRECT RX]1
Anhydrous DextroseINACTIVE INGREDIENT5SL0G7R0OKFLUTICASONE SPRAY, METERED [DIRECT RX]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE SPRAY, METERED [DIRECT RX]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311FLUTICASONE SPRAY, METERED [DIRECT RX]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
PHENETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
Phenylethyl AlcoholINACTIVE INGREDIENTML9LGA7468FLUTICASONE SPRAY, METERED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HFLUTICASONE SPRAY, METERED [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [PREFERRED PHARMACEUTICALS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RFLUTICASONE SPRAY, METERED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-700FLUTICASONE PROPIONATE SPRAY, METERED [AKORN]12Legacy NDC20220315_b7ea1841-2fb1-48c8-86f9-639893fd1a84.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEAsclemed USA, Inc.75049554-64ca-4efa-b8d1-13cf31d0ff902022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077570
application number: ANDA077570

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY532c9b61-9e3f-461b-87c9-9d6b71f6d2e210
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY3e710670-b72c-4a84-8c52-3ebae8783a326
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY5e1d9e90-fbe5-1ce9-e053-2a91aa0a89b44
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY6117a976-f340-4922-943e-237d1e8ec6f94
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYab7529ac-fa19-4be8-9906-8889fa3e83984
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYe709c834-61a5-4797-a8ef-0d5aa990d1362
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY75049554-64ca-4efa-b8d1-13cf31d0ff902
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8ebff74d-0bf9-44cf-a309-25aa85041f991
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY155d0f79-86c2-4096-97f3-5d82762ddc2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-700-09503830700091 BOTTLE, PUMP in 1 BOTTLE, PUMP (50383-700-09) > 9 g in 1 BOTTLE, PUMP2016-01-080000-00-00NoNoCurrent
50383-700-16503830700161 BOTTLE, PUMP in 1 CARTON (50383-700-16) > 16 g in 1 BOTTLE, PUMP2008-01-160000-00-00NoNoCurrent