FLUTICASONE PROPIONATE

Product NDC
61919-930
Requested package NDC
61919-930-16
11-digit product format
619190930
Labeler code
61919
Product ID
61919-930_9c942cdb-cb37-6cec-e053-2995a90a42f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUTICASONE PROPIONATE
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA077055
Marketing category
ANDA
Marketing start
2014-01-01
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 packagepackage61919-93061919-930-16IInactivated 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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
61919-930-152023-01-30C16284748780-1f386c64a-1402-0266-e053-dadaa90a7c1aFLUTICASONE PROPIONATE
61919-930-162023-01-30C16284748780-1f386c64a-1402-0266-e053-dadaa90a7c1aFLUTICASONE PROPIONATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-930-15FLUTICASONE PROPIONATE15 g in 1 TUBECREAM156
61919-930-16FLUTICASONE PROPIONATE15 g in 1 TUBECREAM156

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-930-15GM - Gram61919-930c9bf5516-d1bc-40c0-897f-dfa0457a7a0012015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluticasone PropionateACTIVE INGREDIENTO2GMZ0LF5WFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Ceteth-20INACTIVE INGREDIENTI835H2IHHXFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Mineral OilINACTIVE INGREDIENTT5L8T28FGPFLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLUTICASONE PROPIONATE CREAM [DIRECT RX]4
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74FLUTICASONE PROPIONATE CREAM [DIRECT RX]4
WaterINACTIVE INGREDIENT059QF0KO0RFLUTICASONE PROPIONATE CREAM [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-930FLUTICASONE PROPIONATE CREAM [DIRECT RX]6Legacy NDC, 2 package rows20200130_57468ba5-0a34-4ad3-abfe-0974bba5ddd2.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 CreamPSN57468ba5-0a34-4ad3-abfe-0974bba5ddd26
895987fluticasone propionate 0.5 MG/ML Topical CreamSCD57468ba5-0a34-4ad3-abfe-0974bba5ddd26
895987fluticasone propionate 0.05 % Topical CreamSY57468ba5-0a34-4ad3-abfe-0974bba5ddd26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-930-166191909301615 g in 1 TUBE (61919-930-16) 15 g2014-01-010000-00-00NoNoCurrent