Fluticasone Propionate

Product NDC
51672-4095
11-digit product format
516724095
Labeler code
51672
Product ID
51672-4095_ec64eb18-f4ff-438e-bb6e-a089f963847b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA077145
Marketing category
ANDA
Marketing start
2005-06-14
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
0 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51672-4095DDiscontinued by firm2026-10-05
excluded packagepackage51672-409551672-4095-1DDiscontinued by firm2026-10-05
excluded packagepackage51672-409551672-4095-2DDiscontinued by firm2026-10-05
excluded packagepackage51672-409551672-4095-3DDiscontinued by firm2026-10-05
excluded packagepackage51672-409551672-4095-5DDiscontinued by firm2026-10-05

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage51672-4095-3
excluded packagepackage51672-4095-2
excluded packagepackage51672-4095-5
excluded packagepackage51672-4095-1

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077145-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1484e616aacf4f…
2026-08-18 06:07:402026-07A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-143f01610625f2…
2019-09-15 20:21 UTC2019-09A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077145-001FLUTICASONE PROPIONATE0.005%OINTMENT / TOPICAL2005-06-14f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
51672-4095-12020-02-04These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-22020-02-04These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-32020-02-04These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-52020-02-04These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-12020-01-31These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-22020-01-31These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-32020-01-31These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990
51672-4095-52020-01-31These highlights do not include all the information needed to use FLUTICASONE PROPIONATE OINTMENT safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE OINTMENT. FLUTICASONE PROPIONATE ointment, for topical use Initial U.S. Approval: 1990

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4095FLUTICASONE PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Legacy NDC20241222_ff96762d-a841-4558-befd-d14761bbe6fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4095-1516724095011 TUBE in 1 CARTON (51672-4095-1) > 15 g in 1 TUBE1 tube2005-06-140000-00-00NoNoCurrent
51672-4095-2516724095021 TUBE in 1 CARTON (51672-4095-2) > 30 g in 1 TUBE1 tube2005-06-140000-00-00NoNoCurrent
51672-4095-3516724095031 TUBE in 1 CARTON (51672-4095-3) > 60 g in 1 TUBE1 tube2005-06-140000-00-00NoNoCurrent
51672-4095-5516724095055 g in 1 TUBE (51672-4095-5) 5 g2005-06-140000-00-00NoNoCurrent