FLUTICASONE PROPIONATE

Product NDC
85766-237
11-digit product format
857660237
Labeler code
85766
Product ID
85766-237_57aed772-ff5a-3311-e063-6294a90a60bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Sportpharm LLC
Application
NDA020833
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-10-30
Substance
FLUTICASONE PROPIONATE
Active strength
250 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

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 packagepackage85766-23785766-237-25DDiscontinued by firm2026-10-05

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020833-001FLOVENT DISKUS 50FLUTICASONE PROPIONATE0.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29
N020833-002FLOVENT DISKUS 100FLUTICASONE PROPIONATE0.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29
N020833-003FLOVENT DISKUS 250FLUTICASONE PROPIONATE0.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-29301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
FLUTICASONE PROPIONATE
Brand name suffix
DISKUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE250 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896018Internal RxNorm lookup
896021Internal RxNorm lookup
896025Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
348cbd8c-edeb-499c-961d-3aeb5cc2cef1Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATESportpharm LLC348cbd8c-edeb-499c-961d-3aeb5cc2cef12026-07-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
ndc (product): 85766-237
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutionsda4e897e-9be1-499a-8889-15398b30ef3b2026-05-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions64d669da-559c-40f5-b649-2ce164c211ea2024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
FLOVENT DISKUSFLUTICASONE PROPIONATEA-S Medication Solutions038e6c40-9421-40ef-874b-8f4d7110a74a2024-01-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEPrasco Laboratories44d009ba-d4b8-410f-b2bc-71ab2d05ac9e2023-05-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
FLOVENT DISKUSFLUTICASONE PROPIONATEProficient Rx LP816e929e-6ba0-437d-80bb-00068419ed532019-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-237-60857660237601 INHALER in 1 CARTON (85766-237-60) / 60 POWDER, METERED in 1 INHALER1 inhaler2026-07-02NoNoCurrent