FDA.reportPublic FDA data

OPZELURA

Product NDC
50881-007
11-digit product format
508810007
Labeler code
50881
Product ID
50881-007_a32bcaac-6cd8-41be-8686-3e10268e0539
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ruxolitinib
Dosage form
CREAM
Route
TOPICAL
Labeler
Incyte Corporation
Application
NDA215309
Marketing category
NDA
Marketing start
2021-09-21
Substance
RUXOLITINIB PHOSPHATE
Active strength
15 mg/g
Pharmacologic classes
Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUXOLITINIB PHOSPHATE15 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii436LRU32H5
Rxcui2570752, 2570757

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
54477ffc-bf5d-4583-bcf6-d041bdba36f1Product name120220316
95a946d8-a784-4eb7-bff4-2194e4331c6fProduct name120190828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50881-007-04OPZELURA1 in 1 CARTONCREAM113
50881-007-04OPZELURA5 g in 1 TUBECREAM513
50881-007-05OPZELURA60 g in 1 TUBECREAM6013
50881-007-05OPZELURA1 in 1 CARTONCREAM113
50881-007-07OPZELURA100 g in 1 TUBECREAM10013
50881-007-07OPZELURA1 in 1 CARTONCREAM113
50881-007-14OPZELURA1 in 1 CARTONCREAM113
50881-007-14OPZELURA3 g in 1 TUBECREAM313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50881-007-05GM - Gram50881-0072d0d4914-dbdb-4bf7-98d1-97089f1d714312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50881-007OPZELURA (RUXOLITINIB) CREAM [INCYTE CORPORATION]11Current NDC, Legacy NDC, 8 package rows20240831_24da5509-6631-4795-9d42-273faecd08e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2570757Opzelura 1.5 % Topical CreamPSN24da5509-6631-4795-9d42-273faecd08e713
2570752ruxolitinib 15 MG/ML Topical CreamPSN24da5509-6631-4795-9d42-273faecd08e713
2570757ruxolitinib 15 MG/ML Topical Cream [Opzelura]SBD24da5509-6631-4795-9d42-273faecd08e713
2570752ruxolitinib 15 MG/ML Topical CreamSCD24da5509-6631-4795-9d42-273faecd08e713
2570757Opzelura 1.5 % Topical CreamSY24da5509-6631-4795-9d42-273faecd08e713
2570757Opzelura 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical CreamSY24da5509-6631-4795-9d42-273faecd08e713
2570757Opzelura 15 MG/ML Topical CreamSY24da5509-6631-4795-9d42-273faecd08e713
2570752ruxolitinib 1.5 % Topical CreamSY24da5509-6631-4795-9d42-273faecd08e713
2570752ruxolitinib 15 MG (as ruxolitinib phosphate 19.8 MG) per 1 GM Topical CreamSY24da5509-6631-4795-9d42-273faecd08e713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50881-007-04508810007041 TUBE in 1 CARTON (50881-007-04) / 5 g in 1 TUBE1 tube2021-09-210000-00-00YesNoCurrent
50881-007-05508810007051 TUBE in 1 CARTON (50881-007-05) / 60 g in 1 TUBE1 tube2021-09-210000-00-00NoNoCurrent
50881-007-07508810007071 TUBE in 1 CARTON (50881-007-07) / 100 g in 1 TUBE1 tube2022-04-150000-00-00NoNoCurrent
50881-007-14508810007141 TUBE in 1 CARTON (50881-007-14) / 3 g in 1 TUBE1 tube2025-11-10YesNoHistorical