FLOVENT

Product NDC
0173-0601
11-digit product format
001730601
Labeler code
0173
Product ID
0173-0601_995f7d42-c1ba-4de2-aff5-9b02187ab606
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluticasone propionate
Dosage form
POWDER, METERED
Route
RESPIRATORY (INHALATION)
Labeler
GlaxoSmithKline LLC
Application
NDA020833
Marketing category
NDA
Marketing start
2008-10-13
Marketing end
0000-00-00
Substance
FLUTICASONE PROPIONATE
Active strength
250 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0173-0601DDiscontinued by firm2026-08-10
excluded packagepackage0173-06010173-0601-02DDiscontinued by firm2026-08-10

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
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0173-0601DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0173-06010173-0601-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0601-00EA - Each0173-06013e513ade-bf2a-4dda-ac0b-ddba4fdcb20612012-07-24
0173-0601-02EA - Each0173-060155e21c8f-c714-4cd8-a2a1-a6f30f4c9c5412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [GLAXOSMITHKLINE LLC]19
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [GLAXOSMITHKLINE LLC]19
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GFLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [GLAXOSMITHKLINE LLC]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0601FLOVENT DISKUS (FLUTICASONE PROPIONATE) POWDER, METERED [GLAXOSMITHKLINE LLC]34Legacy NDC20240915_001f22f8-a83d-495f-9196-d0264ef4d76e.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 · 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
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 startMarketing endSampleExclude flagStatus
0173-0601-00001730601001 INHALER in 1 CARTON (0173-0601-00) > 28 POWDER, METERED in 1 INHALER1 inhaler2008-10-132022-05-31NoNoCurrent
0173-0601-02001730601021 INHALER in 1 CARTON (0173-0601-02) > 60 POWDER, METERED in 1 INHALER1 inhaler2008-10-130000-00-00NoNoCurrent