Fluticasone Propionate

Product NDC
50090-3803
Requested package NDC
50090-3803-0
11-digit product format
500903803
Labeler code
50090
Product ID
50090-3803_f2527866-f09d-489d-9875-7f4f0bd208f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA077055
Marketing category
ANDA
Marketing start
2006-06-30
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-380350090-3803-0IInactivated by FDA2026-08-03

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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A077055-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077055-001AB

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 UTC2026-02A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077055-001FLUTICASONE PROPIONATE0.05%CREAM / TOPICALAB2006-06-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077055-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077055-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077055-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077055-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077055-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077055-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077055-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077055-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077055-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077055-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077055-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077055-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077055-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077055-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077055-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077055-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077055-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077055-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077055-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077055-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077055-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077055-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077055-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077055-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077055-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077055-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077055-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077055-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077055-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077055-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077055-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077055-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077055-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077055-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077055-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077055-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077055-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077055-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077055-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077055-001AB1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3803-02023-01-30C16284748780-1f386c649-9af8-0266-e053-dadaa90a7c1aFluticasone Propionate Cream, USP 0.05% For Dermatologic Use Only-Not for Ophthalmic Use. Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3803-0Fluticasone Propionate60 g in 1 TUBECREAM603
50090-3803-0Fluticasone Propionate1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3803FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE) CREAM [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200122_c95c674d-9dbc-41f6-a063-df427050d8eb.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 PROPIONATECosette Pharmaceuticals, Inc.14c8d082-b301-8f09-a509-950459ae0a282022-05-05Adverse reactionsExact identifier
application applno (ANDA): 077055
application number: ANDA077055

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
895987fluticasone propionate 0.05 % Topical CreamPSNc95c674d-9dbc-41f6-a063-df427050d8eb3
895987fluticasone propionate 0.5 MG/ML Topical CreamSCDc95c674d-9dbc-41f6-a063-df427050d8eb3
895987fluticasone propionate 0.05 % Topical CreamSYc95c674d-9dbc-41f6-a063-df427050d8eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3803-0500903803001 TUBE in 1 CARTON (50090-3803-0) > 60 g in 1 TUBE1 tube2018-11-090000-00-00NoNoCurrent