FDA.reportPublic FDA data

Finacea

Product NDC
10922-825
11-digit product format
109220825
Labeler code
10922
Product ID
10922-825_a7594a20-f46e-4b33-91d5-410cc5e97b8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azelaic acid
Dosage form
GEL
Route
TOPICAL
Labeler
Intendis Inc.
Application
NDA021470
Marketing category
NDA
Marketing start
2004-12-24
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
10922-825-022019-11-27C16284748780-19855d018-d63a-cd31-e053-dbdaa90ab51aFinacea ® (azelaic acid) Gel, 15%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10922-825-02Finacea50 g in 1 TUBEGEL505
10922-825-02Finacea1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10922-825-02GM - Gram10922-82586050828-5e8f-4bf5-ac59-897918611e0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZELAIC ACIDACTIVE INGREDIENTF2VW3D43YTFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
AZELAIC ACIDACTIVE MOIETYF2VW3D43YTFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINEINACTIVE INGREDIENTHE0P2D9ZLSFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C61FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X7FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CERAMIDE 3INACTIVE INGREDIENT4370DF050BFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00JFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2QFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV8FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
POTASSIUM PHOSPHATE, UNSPECIFIED FORMINACTIVE INGREDIENTB7862WZ632FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEFINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5
AZELAIC ACIDACTIVE INGREDIENTF2VW3D43YTFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
AZELAIC ACIDACTIVE MOIETYF2VW3D43YTFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFINACEA (AZELAIC ACID) GEL [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10922-825FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]5Legacy NDC, 2 package rows20130507_63773349-0295-4d56-a72e-0d7cade88ddb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041518azelaic acid 15 % Topical GelPSN63773349-0295-4d56-a72e-0d7cade88ddb5
1043748Finacea 15 % Topical GelPSN63773349-0295-4d56-a72e-0d7cade88ddb5
1043748azelaic acid 0.15 MG/MG Topical Gel [Finacea]SBD63773349-0295-4d56-a72e-0d7cade88ddb5
1041518azelaic acid 0.15 MG/MG Topical GelSCD63773349-0295-4d56-a72e-0d7cade88ddb5
1041518azelaic acid 15 % Topical GelSY63773349-0295-4d56-a72e-0d7cade88ddb5
1043748Finacea 0.15 MG/MG Topical GelSY63773349-0295-4d56-a72e-0d7cade88ddb5
1043748Finacea 15 % Topical GelSY63773349-0295-4d56-a72e-0d7cade88ddb5
1043748Finacea Plus (azelaic acid 0.15 MG/MG) Topical GelSY63773349-0295-4d56-a72e-0d7cade88ddb5
1041518azelaic acid 15 % Topical GelPSN6c5e836c-2851-4524-b91d-12ffadffd9ba1
1043748Finacea 15 % Topical GelPSN6c5e836c-2851-4524-b91d-12ffadffd9ba1
1043748azelaic acid 0.15 MG/MG Topical Gel [Finacea]SBD6c5e836c-2851-4524-b91d-12ffadffd9ba1
1041518azelaic acid 0.15 MG/MG Topical GelSCD6c5e836c-2851-4524-b91d-12ffadffd9ba1
1041518azelaic acid 15 % Topical GelSY6c5e836c-2851-4524-b91d-12ffadffd9ba1
1043748Finacea 0.15 MG/MG Topical GelSY6c5e836c-2851-4524-b91d-12ffadffd9ba1
1043748Finacea 15 % Topical GelSY6c5e836c-2851-4524-b91d-12ffadffd9ba1
1043748Finacea Plus (azelaic acid 0.15 MG/MG) Topical GelSY6c5e836c-2851-4524-b91d-12ffadffd9ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
10922-825-021092208250250 g in 1 TUBE50 gHistorical