FDA.reportPublic FDA data

Finacea

Product NDC
50090-3032
11-digit product format
500903032
Labeler code
50090
Product ID
50090-3032_0e2fadc5-3a2e-4027-93ba-eff9990cfc65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelaic acid
Dosage form
GEL
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
NDA021470
Marketing category
NDA
Marketing start
2002-12-24
Marketing end
0000-00-00
Substance
AZELAIC ACID
Active strength
0 g/g
Pharmacologic classes
Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3032-02023-01-30C16284748780-1f386c64a-3729-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3032-0Finacea50 g in 1 TUBEGEL503
50090-3032-0Finacea1 in 1 CARTONGEL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3032-0GM - Gram50090-3032af449811-a084-48d7-874e-1ea4f17bb35612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3032FINACEA (AZELAIC ACID) GEL [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200121_9f40cd45-58a6-4376-9220-84bfe7d7e358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041518azelaic acid 15 % Topical GelPSN9f40cd45-58a6-4376-9220-84bfe7d7e3583
1043748Finacea 15 % Topical GelPSN9f40cd45-58a6-4376-9220-84bfe7d7e3583
1043748azelaic acid 0.15 MG/MG Topical Gel [Finacea]SBD9f40cd45-58a6-4376-9220-84bfe7d7e3583
1041518azelaic acid 0.15 MG/MG Topical GelSCD9f40cd45-58a6-4376-9220-84bfe7d7e3583
1041518azelaic acid 15 % Topical GelSY9f40cd45-58a6-4376-9220-84bfe7d7e3583
1043748Finacea 0.15 MG/MG Topical GelSY9f40cd45-58a6-4376-9220-84bfe7d7e3583
1043748Finacea 15 % Topical GelSY9f40cd45-58a6-4376-9220-84bfe7d7e3583
1043748Finacea Plus (azelaic acid 0.15 MG/MG) Topical GelSY9f40cd45-58a6-4376-9220-84bfe7d7e3583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3032-0500903032001 TUBE in 1 CARTON (50090-3032-0) > 50 g in 1 TUBE1 tube2017-06-010000-00-00NoNoCurrent