FDA.reportPublic FDA data

Incruse Ellipta

Product NDC
0173-0873
11-digit product format
001730873
Labeler code
0173
Product ID
0173-0873_4049ca45-7739-4d4a-bcce-50c5b3c7415f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
umeclidinium
Dosage form
AEROSOL, POWDER
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA205382
Marketing category
NDA
Marketing start
2014-04-30
Substance
UMECLIDINIUM BROMIDE
Active strength
62.5 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205382-001INCRUSE ELLIPTAUMECLIDINIUM BROMIDEEQ 0.0625MG BASE/INHPOWDER / INHALATIONRLD, RS2014-04-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205382-00174888272027-12-18Drug substance, Drug product2014-05-21

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N205382-001INCRUSE ELLIPTAEQ 0.0625MG BASE/INHPOWDER / INHALATIONRLD, RS2014-04-30a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N205382-00174888272027-12-18Drug substance, Drug product2014-05-21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Umeclidinium ElliptaUMECLIDINIUMPrasco Laboratories763388a5-cc89-4c25-8562-521df679b7e82025-11-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 205382
application number: NDA205382
Incruse ElliptaUMECLIDINIUMGlaxoSmithKline LLCdbb64747-1505-49d7-9a33-99dd402e96d32023-12-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 205382
application number: NDA205382
ndc (product): 0173-0873

Additional Listing Data#

Finished product
Yes
Brand name base
Incruse Ellipta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UMECLIDINIUM BROMIDE62.5 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7AN603V4JVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1539251Internal RxNorm lookup
1539885Internal RxNorm lookup
1596444Internal RxNorm lookup
1596445Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbb64747-1505-49d7-9a33-99dd402e96d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8f051f0-c83d-4101-9511-7c3765599726Product name120190910
c982201d-72cb-462f-9e02-902ec0d4a295Product name120181030
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0873-06Incruse Ellipta1 in 1 CARTONAEROSOL, POWDER127
0173-0873-06Incruse Ellipta1 in 1 TRAYAEROSOL, POWDER127
0173-0873-10Incruse Ellipta1 in 1 TRAYAEROSOL, POWDER127
0173-0873-10Incruse Ellipta1 in 1 CARTONAEROSOL, POWDER127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0873-06EA - Each0173-0873bb966823-bab6-4cec-872b-db9eb7f63b0a12015-01-05
0173-0873-10EA - Each0173-087334214c66-8b12-45c1-a06b-3869a8a90a9812015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UMECLIDINIUM BROMIDEACTIVE INGREDIENT7AN603V4JVINCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]5
UMECLIDINIUMACTIVE MOIETYGE2T1418SVINCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0873INCRUSE ELLIPTA (UMECLIDINIUM) AEROSOL, POWDER [GLAXOSMITHKLINE LLC]25Current NDC, Legacy NDC, 4 package rows20250525_dbb64747-1505-49d7-9a33-99dd402e96d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1539885Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSNdbb64747-1505-49d7-9a33-99dd402e96d327
1596445Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 7 BlistersPSNdbb64747-1505-49d7-9a33-99dd402e96d327
1539251umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 BlistersPSNdbb64747-1505-49d7-9a33-99dd402e96d327
1596444umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 7 BlistersPSNdbb64747-1505-49d7-9a33-99dd402e96d327
153988530 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse]SBDdbb64747-1505-49d7-9a33-99dd402e96d327
15964457 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder Inhaler [Incruse]SBDdbb64747-1505-49d7-9a33-99dd402e96d327
153925130 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder InhalerSCDdbb64747-1505-49d7-9a33-99dd402e96d327
15964447 ACTUAT umeclidinium 0.0625 MG/ACTUAT Dry Powder InhalerSCDdbb64747-1505-49d7-9a33-99dd402e96d327
1539885Incruse Ellipta (umeclidinium 62.5 MCG) per ACTUAT Dry Powder Inhaler, 30 ACTUATSYdbb64747-1505-49d7-9a33-99dd402e96d327
1596445Incruse Ellipta (umeclidinium 62.5 MCG) per ACTUAT Dry Powder Inhaler, 7 ACTUATSYdbb64747-1505-49d7-9a33-99dd402e96d327
1539885Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 30 BlistersSYdbb64747-1505-49d7-9a33-99dd402e96d327
1596445Incruse Ellipta 62.5 MCG/INHAL Dry Powder Inhaler, 7 BlistersSYdbb64747-1505-49d7-9a33-99dd402e96d327
1539251umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 30 BlistersSYdbb64747-1505-49d7-9a33-99dd402e96d327
1596444umeclidinium 62.5 MCG/INHAL Dry Powder Inhaler, 7 BlistersSYdbb64747-1505-49d7-9a33-99dd402e96d327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0873-06001730873061 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER1 tray2014-04-300000-00-00NoNoCurrent
0173-0873-10001730873101 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER1 tray2014-04-300000-00-00NoNoCurrent
0173-0873-61001730873611 TRAY in 1 CARTON (0173-0873-61) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER1 tray2014-04-300000-00-00NoNoCurrent