Fluticasone Propionate

Product NDC
21695-704
11-digit product format
216950704
Labeler code
21695
Product ID
21695-704_155d0f79-86c2-4096-97f3-5d82762ddc2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-704IInactivated by FDA2026-08-17
excluded packagepackage21695-70421695-704-16IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-704-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-704-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-704-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-704-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-704-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-704-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-704-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-704-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-704-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-704-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-704-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-704-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-704-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-704-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-704-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-704-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-704-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-704-16bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-704-168dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-704-16e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-704-169bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-704-16110d247fa046…a55b01930146…

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
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-704-162019-09-24C16284748780-1934fe258-4c53-48b1-e053-8cdaa90a720aFluticasone Propionate Nasal Spray, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-704-16Fluticasone Propionate16 g in 1 BOTTLE, PUMPSPRAY, METERED161
21695-704-16Fluticasone Propionate1 in 1 CARTONSPRAY, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-704-16GM - Gram21695-70461b0be2d-d2ef-4503-93d9-60685b8fbb4312012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-704FLUTICASONE PROPIONATE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110113_155d0f79-86c2-4096-97f3-5d82762ddc2e.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 SprayPSN155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD155d0f79-86c2-4096-97f3-5d82762ddc2e1
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY155d0f79-86c2-4096-97f3-5d82762ddc2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-704-162169507041616 g in 1 BOTTLE, PUMP16 gHistorical