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

Additional Listing Data#

Finished product
Yes
Brand name base
Anzupgo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DELGOCITINIB20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9L0Q8KK220
Rxcui2721167, 2721172

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

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