Fluticasone Propionate

Product NDC
72189-004
Requested package NDC
72189-004-01
11-digit product format
721890004
Labeler code
72189
Product ID
72189-004_4d3a96c7-d9d7-c351-e063-6394a90a680d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Direct_RX
Application
ANDA077538
Marketing category
ANDA
Marketing start
2019-06-18
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-00472189-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-00472189-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A077538-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077538-001AB

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 UTC2026-02A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-123f01610625f2…
2019-09-15 20:21 UTC2019-09A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077538-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALAB2007-09-12cb3db0bc1861…

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 UTC2026-02A077538-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077538-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077538-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077538-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077538-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077538-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077538-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077538-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077538-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077538-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077538-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077538-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077538-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077538-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077538-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077538-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077538-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077538-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077538-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077538-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077538-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077538-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077538-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077538-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077538-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077538-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077538-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077538-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077538-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077538-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077538-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077538-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077538-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077538-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077538-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077538-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077538-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077538-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077538-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077538-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797907Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b9f7474-8d89-b3e6-e053-2995a90aeddbAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-004-01Fluticasone Propionate1 in 1 BOTTLE, SPRAYSPRAY, METERED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-004-01GM - Gram72189-004f132b52a-3a72-4dd5-834a-e76d5634366612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-004FLUTICASONE PROPIONATE SPRAY, METERED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250130_8b9f7474-8d89-b3e6-e053-2995a90aeddb.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEPreferred Pharmaceuticals, Inc.4916301d-bcc8-4cd1-86b4-7bf0aecfbf682026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEDirect_RX8b9f7474-8d89-b3e6-e053-2995a90aeddb2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
ndc (package): 72189-004-01
ndc (product): 72189-004
ndc11 (package): 72189000401
Fluticasone PropionateFLUTICASONE PROPIONATEIPG Pharmaceuticals, Inc.f1965bd9-1851-4be5-bbe0-71dd59e034d52026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEREMEDYREPACK INC.d781dd49-ed8d-4204-99ac-a3b632d7640a2026-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEGolden State Medical Supply, Inc.db857d81-4b1e-42b8-972a-5bb8735d60f82025-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.3830675d-b45e-fc97-1f73-674b1fc38c802025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEAsclemed USA, Inc.504397c5-6f9f-45cc-9cc9-997da0a803642025-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEQuality Care Products, LLC1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e2024-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEProficient Rx LP1d5d5f27-6565-4e7b-9923-faa3d15cb1c42024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538
Fluticasone PropionateFLUTICASONE PROPIONATEA-S Medication Solutionse2df3810-3b92-4678-8f62-683c656b1de92023-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077538
application number: ANDA077538

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN8b9f7474-8d89-b3e6-e053-2995a90aeddb3
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD8b9f7474-8d89-b3e6-e053-2995a90aeddb3
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY8b9f7474-8d89-b3e6-e053-2995a90aeddb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-004-01721890004011 SPRAY, METERED in 1 BOTTLE, SPRAY (72189-004-01) 2019-06-180000-00-00NoNoCurrent