Home RxNorm 1043753 azelaic acid 200 MG/ML Topical Cream [Azelex] Drug identity information. FDA.report links public drug records from RxNav, DailyMed, FDA NDC, Drugs@FDA, and related public sources where available. This page is informational only and is not medical, prescribing, or regulatory advice.
RxCUI 1043753
RxNorm name azelaic acid 200 MG/ML Topical Cream [Azelex]
Display name AZELEX (Topical)
Full name azelaic acid 200 MG/ML Topical Cream [Azelex]
Term type SBD
Status Active
Strength 20%
Dose form Cream
Route Topical
Updated 2026-10-27 17:47:34 RxNorm Status History#
Status Active
Source RXNORM
Current YES
Release start 122010
Active start 122010
Multiple ingredient NO
Branded YES Ingredients And Strength# Ingredient, Strength, Base table Ingredient Strength Base Basis of strength azelaic acid 200 MG / 1 ML azelate azelaic acid
Derived Ingredient Concepts# Ingredient, RxCUI table Ingredient RxCUI azelate 618278
FDA NDC Products And Packages# Drugs@FDA Applications# Application, NDC, Name table Application NDC Name Marketing category Labeler NDA020428 16110-869 AZELEX azelaic acid NDA Almirall, LLC
RxNav Current And Historical NDCs# RxNav current and historical NDC rows page 1 of 1 · 14 matching rows.
NDC11, Source, Active table NDC11 Source Active 00023869430 rxnav_ndcs yes 00023869450 rxnav_ndcs yes 16110086930 rxnav_ndcs yes 16110086950 rxnav_ndcs yes 00023869400 rxnav_historical 00023869405 rxnav_historical 00247175430 rxnav_historical 12866869403 rxnav_historical 12866869405 rxnav_historical 35356021730 rxnav_historical 35356021750 rxnav_historical 35356021850 rxnav_historical 54569463500 rxnav_historical 54868444200 rxnav_historical
UNII Substances# UNII substance links page 1 of 1 · 0 matching rows.
No records found.
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Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings# unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.
Set ID, RxNorm mappings, Terms table Set ID RxNorm mappings Terms SPL version Label Effective ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75 Azelex 20 % Topical Cream [PSN] · azelaic acid 200 MG/ML Topical Cream [Azelex] [SBD] · Azelex 20 % Topical Cream [SY] · Azelex 200 MG/ML Topical Cream [SY] 4 6 AZELEX ® (azelaic acid cream) 20% 20240304 0d5269d5-6555-4d2c-bc3b-df862b014275 Azelex 20 % Topical Cream [PSN] · azelaic acid 200 MG/ML Topical Cream [Azelex] [SBD] · Azelex 20 % Topical Cream [SY] · Azelex 200 MG/ML Topical Cream [SY] 4 1 AZELEX® (azelaic acid cream) 20% 20120611
Recently Linked DailyMed Labels# Properties# Category, Property, Value table Category Property Value ATTRIBUTES AVAILABLE_STRENGTH 200 MG/ML (expressed as azelaic acid) ATTRIBUTES GENERAL_CARDINALITY SINGLE ATTRIBUTES HUMAN_DRUG US ATTRIBUTES RXNAV_HUMAN_DRUG US ATTRIBUTES SCHEDULE 0 CODES NDA NDA020428 NAMES Prescribable Synonym Azelex 20 % Topical Cream SOURCES Source Gold Standard Alchemy SOURCES Source Metathesaurus FDA Structured Product Labels SOURCES Source Micromedex RED BOOK SOURCES Source Multum MediSource Lexicon