FDA.reportPublic FDA data

FINACEA FOAM

Product NDC
50222-303
11-digit product format
502220303
Labeler code
50222
Product ID
50222-303_f51a0452-513f-488f-b0f9-b723cf96bdf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelaic acid
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
LEO Pharma Inc.
Application
NDA207071
Marketing category
NDA
Marketing start
2018-10-01
Substance
AZELAIC ACID
Active strength
.15 g/g
Pharmacologic classes
Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELAIC ACID.15 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2VW3D43YT
Rxcui1659800, 1659803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50222-303-50FINACEA FOAM50 g in 1 CANAEROSOL, FOAM503
50222-303-50FINACEA FOAM1 in 1 CARTONAEROSOL, FOAM13
50222-303-91FINACEA FOAM1 in 1 CARTONAEROSOL, FOAM13
50222-303-91FINACEA FOAM15 g in 1 CANAEROSOL, FOAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50222-303-50GM - Gram50222-3035e5aea89-8483-4e17-8707-789af0eec49e12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50222-303FINACEA FOAM (AZELAIC ACID) AEROSOL, FOAM [LEO PHARMA INC.]3Current NDC, Legacy NDC, 4 package rows20201218_9fabd24e-4c3b-49a0-aa5f-c8d75ae67572.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659800azelaic acid 15 % Topical FoamPSN9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659803Finacea 15 % Topical FoamPSN9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659803azelaic acid 150 MG/ML Topical Foam [Finacea]SBD9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659800azelaic acid 150 MG/ML Topical FoamSCD9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659800azelaic acid 15 % Topical FoamSY9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659803Finacea 15 % Topical FoamSY9fabd24e-4c3b-49a0-aa5f-c8d75ae675723
1659803Finacea 150 MG/ML Topical FoamSY9fabd24e-4c3b-49a0-aa5f-c8d75ae675723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50222-303-50502220303501 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN1 can2018-10-010000-00-00NoNoCurrent
50222-303-91502220303911 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN1 can2018-10-010000-00-00YesNoCurrent