FDA.reportPublic FDA data

Anzupgo

Product NDC
50222-280
11-digit product format
502220280
Labeler code
50222
Product ID
50222-280_01c060c1-bd52-44ba-b2f4-e033279ed354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
delgocitinib
Dosage form
CREAM
Route
TOPICAL
Labeler
LEO Pharma, Inc
Application
NDA219155
Marketing category
NDA
Marketing start
2025-07-24
Substance
DELGOCITINIB
Active strength
20 mg/g
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
N219155-001ANZUPGODELGOCITINIB2%CREAM / TOPICALRLD, RS2025-07-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219155-00186096472031-09-19U-4237Drug substance, Drug product2025-08-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219155-001NCE2030-07-23

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
2026-02-19 14:30 UTC2026-02N219155-001ANZUPGO2%CREAM / TOPICALRLD, RS2025-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219155-001ANZUPGO2%CREAM / TOPICALRLD, RS2025-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219155-001ANZUPGO2%CREAM / TOPICALRLD, RS2025-07-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219155-001ANZUPGO2%CREAM / TOPICALRLD, RS2025-07-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N219155-00186096472031-09-19U-4237Drug substance, Drug product2025-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219155-00186096472031-09-19U-4237Drug substance, Drug product2025-08-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219155-00186096472031-09-19U-4237Drug substance, Drug product2025-08-21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N219155-001NCE2030-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219155-001NCE2030-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219155-001NCE2030-07-236a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219155-001NCE2030-07-23a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DELGOCITINIB20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9L0Q8KK220Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2721167Internal RxNorm lookup
2721172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a59bf36e-6f04-4b47-b385-8040c95f040cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50222-280-30Anzupgo30 g in 1 TUBECREAM304
50222-280-30Anzupgo1 in 1 CARTONCREAM14
50222-280-91Anzupgo15 g in 1 TUBECREAM154
50222-280-91Anzupgo1 in 1 CARTONCREAM14
50222-280-99Anzupgo1 in 1 CARTONCREAM14
50222-280-99Anzupgo5 g in 1 TUBECREAM54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-280-30GM - Gram50222-2806a9e0bb2-e4a6-46e6-946a-9f485f95697012025-08-11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnzupgoDELGOCITINIBLEO Pharma, Inca59bf36e-6f04-4b47-b385-8040c95f040c2026-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 219155
application number: NDA219155
ndc (product): 50222-280

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2721172Anzupgo 2 % Topical CreamPSNa59bf36e-6f04-4b47-b385-8040c95f040c4
2721167delgocitinib 2 % Topical CreamPSNa59bf36e-6f04-4b47-b385-8040c95f040c4
2721172delgocitinib 20 MG/ML Topical Cream [Anzupgo]SBDa59bf36e-6f04-4b47-b385-8040c95f040c4
2721167delgocitinib 20 MG/ML Topical CreamSCDa59bf36e-6f04-4b47-b385-8040c95f040c4
2721172Anzupgo 2 % Topical CreamSYa59bf36e-6f04-4b47-b385-8040c95f040c4
2721167delgocitinib 2 % Topical CreamSYa59bf36e-6f04-4b47-b385-8040c95f040c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50222-280-30502220280301 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE1 tube2025-07-24NoNoCurrent
50222-280-91502220280911 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE1 tube2025-07-24YesNoCurrent
50222-280-99502220280991 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE1 tube2025-08-30YesNoCurrent