FLUTICASONE PROPIONATE

Product NDC
50090-7962
11-digit product format
500907962
Labeler code
50090
Product ID
50090-7962_d385a790-e374-4f2a-94c5-e57815fc68c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA020833
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-10-30
Substance
FLUTICASONE PROPIONATE
Active strength
100 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020833-001FLOVENT 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020833-002FLOVENT DISKUS 1000.1MG/INHPOWDER / INHALATIONRLD, RS2000-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020833-003FLOVENT DISKUS 2500.25MG/INHPOWDER / INHALATIONRLD, RS2000-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020833-001FLOVENT DISKUS 500.05MG/INHPOWDER / INHALATIONRLD, RS2000-09-298072bd15b7f6…

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 PROPIONATE100 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
896021Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
da4e897e-9be1-499a-8889-15398b30ef3bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7962-0FLUTICASONE PROPIONATEDISKUS60 in 1 INHALERPOWDER, METERED601
50090-7962-0FLUTICASONE PROPIONATEDISKUS1 in 1 CARTONPOWDER, METERED11

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-3aeb5cc2cef12026-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
FLUTICASONE PROPIONATE DISKUSFLUTICASONE PROPIONATEA-S Medication Solutionsda4e897e-9be1-499a-8889-15398b30ef3b2026-05-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020833
application number: NDA020833
ndc (product): 50090-7962
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896021fluticasone propionate 100 MCG/INHAL Dry Powder Inhaler, 60 BlistersPSNda4e897e-9be1-499a-8889-15398b30ef3b1
89602160 ACTUAT fluticasone propionate 0.1 MG/ACTUAT Dry Powder InhalerSCDda4e897e-9be1-499a-8889-15398b30ef3b1
896021fluticasone propionate 0.1 MG/ACTUAT Dry Powder Inhaler, 60 ACTUATSYda4e897e-9be1-499a-8889-15398b30ef3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7962-0500907962001 INHALER in 1 CARTON (50090-7962-0) / 60 POWDER, METERED in 1 INHALER1 inhaler2026-05-11NoNoCurrent