FDA.reportPublic FDA data

azelaic acid 0.15 MG/MG Topical Gel

RxCUI
1041518
RxNorm name
azelaic acid 0.15 MG/MG Topical Gel
Display name
Azelate (Topical)
Full name
azelaic acid 0.15 MG/MG Topical Gel
Term type
SCD
Status
Active
Strength
15%
Dose form
Gel
Route
Topical
Updated
2026-10-27 17:47:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
azelaic acid0.15 MG / 1 MGazelateazelaic acid

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
azelate618278

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRazelaic acid 0.15 MG/MG Topical Gel1NAMES
RxNorm Nameazelaic acid 0.15 MG/MG Topical Gel1NAMES
RxNorm Synonymazelaic acid 15 % Topical Gel1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
6 linked values
6CODES
RxCUI10415181CODES
MMSL_CODE
3 linked values
3CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0591-2131-550591-2131azelaic acid azelaic acidActavis Pharma, Inc.ANDA208011
0781-7172-500781-7172Azelaic Acid Gel azelaic acidSandoz Inc.NDA021470
21922-038-1421922-038Azelaic Acid Gel Azelaic AcidEncube Ethicals, Inc.ANDA208724
51672-1389-351672-1389Azelaic Acid Azelaic AcidSun Pharmaceutical Industries, Inc.ANDA210549
68462-626-5268462-626azelaic acid azelaic acidGlenmark Pharmaceuticals Inc., USAANDA204637
72162-2297-272162-2297Azelaic Acid Gel Azelaic AcidBryant Ranch PrepackANDA208724

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA2080110591-2131azelaic acid azelaic acidANDAActavis Pharma, Inc.
NDA0214700781-7172Azelaic Acid Gel azelaic acidNDA AUTHORIZED GENERICSandoz Inc.
ANDA20872421922-038Azelaic Acid Gel Azelaic AcidANDAEncube Ethicals, Inc.
ANDA21054951672-1389Azelaic Acid Azelaic AcidANDASun Pharmaceutical Industries, Inc.
ANDA20463768462-626azelaic acid azelaic acidANDAGlenmark Pharmaceuticals Inc., USA

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 19 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00591213155rxnav_ndcsyes
00781717250rxnav_ndcsyes
21922003814rxnav_ndcsyes
51672138903rxnav_ndcsyes
68462062652rxnav_ndcsyes
72162229702rxnav_ndcsyes
00115162456rxnav_historical
10922082502rxnav_historical_indirect
10922082571rxnav_historical_indirect
47781044764rxnav_historical
47781044765rxnav_historical
50419082501rxnav_historical_indirect
50419082502rxnav_historical_indirect
50419082571rxnav_historical_indirect
54868523600rxnav_historical
66194082501rxnav_historical_indirect
66194082502rxnav_historical_indirect
66194082503rxnav_historical_indirect
68462062642rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azelaic Acid GelAZELAIC ACIDBryant Ranch Prepack9c151fc7-cb0b-4931-9c1b-0c29f46ac21f2026-05-21Warnings, Adverse reactionsExact identifier
ndc (package): 72162-2297-2
ndc (product): 72162-2297
ndc11 (package): 72162229702
rxcui: 1041518
Azelaic Acid GelAZELAIC ACIDEncube Ethicals, Inc.ab3f174c-a3c4-4ae9-b0bc-954efaadf8de2025-12-24Warnings, Adverse reactionsExact identifier
ndc (package): 21922-038-14
ndc (product): 21922-038
ndc11 (package): 21922003814
rxcui: 1041518
Azelaic AcidAZELAIC ACIDSun Pharmaceutical Industries, Inc.d4e9e95d-1ebd-44df-a91e-59819715659c2025-08-22Warnings, Adverse reactionsExact identifier
ndc (package): 51672-1389-3
ndc (product): 51672-1389
ndc11 (package): 51672138903
rxcui: 1041518
azelaic acidAZELAIC ACIDActavis Pharma, Inc.66298d50-d4e2-4852-bbab-581389c488cb2022-05-30Warnings, Adverse reactionsExact identifier
ndc (package): 0591-2131-55
ndc (product): 0591-2131
ndc11 (package): 00591213155
rxcui: 1041518
azelaic acidAZELAIC ACIDGlenmark Pharmaceuticals Inc., USA0b5ab22e-c78a-4429-9a76-a4ba2d11fcde2021-12-23Warnings, Adverse reactionsExact identifier
ndc (package): 68462-626-52
ndc (product): 68462-626
ndc11 (package): 68462062652
rxcui: 1041518
Azelaic Acid GelAZELAIC ACIDSandoz Inc.66178511-5c1a-4ecd-bc98-2ceb54e710ac2021-11-11Warnings, Adverse reactionsExact identifier
ndc (package): 0781-7172-50
ndc (product): 0781-7172
ndc11 (package): 00781717250
rxcui: 1041518

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 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9c151fc7-cb0b-4931-9c1b-0c29f46ac21fazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]3103These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 199520260521
66298d50-d4e2-4852-bbab-581389c488cbazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]311These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 199520220530
66178511-5c1a-4ecd-bc98-2ceb54e710acazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]38These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 199520211111
d4e9e95d-1ebd-44df-a91e-59819715659cazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]35These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 199520250822
0b5ab22e-c78a-4429-9a76-a4ba2d11fcdeazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]35These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID Gel, for topical use Initial U.S. Approval: 199520211223
63773349-0295-4d56-a72e-0d7cade88ddbazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]35Finacea ® (azelaic acid) Gel, 15%20110412
ab3f174c-a3c4-4ae9-b0bc-954efaadf8deazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]33These highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 199520251224
9f40cd45-58a6-4376-9220-84bfe7d7e358azelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]33These 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: 199520200118
6c5e836c-2851-4524-b91d-12ffadffd9baazelaic acid 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [SCD] · azelaic acid 15 % Topical Gel [SY]3120100831

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9c151fc7-cb0b-4931-9c1b-0c29f46ac21fThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Bryant Ranch Prepack20260521
9c151fc7-cb0b-4931-9c1b-0c29f46ac21fThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Bryant Ranch Prepack20260318
ab3f174c-a3c4-4ae9-b0bc-954efaadf8deThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Encube Ethicals, Inc. | Encube Ethicals Private Limited20251224
ab3f174c-a3c4-4ae9-b0bc-954efaadf8deThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Encube Ethicals, Inc. | Encube Ethicals Private Limited20250904
d4e9e95d-1ebd-44df-a91e-59819715659cThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.20250822
66298d50-d4e2-4852-bbab-581389c488cbThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Actavis Pharma, Inc.20220530
0b5ab22e-c78a-4429-9a76-a4ba2d11fcdeThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID Gel, for topical use Initial U.S. Approval: 1995Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited20211223
ed69bd06-9eae-4354-9250-dc92e16480acThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Amneal Pharmaceuticals of New York LLC | TOLMAR Inc.20211118
66178511-5c1a-4ecd-bc98-2ceb54e710acThese highlights do not include all the information needed to use AZELAIC ACID GEL safely and effectively. See full prescribing information for AZELAIC ACID GEL. AZELAIC ACID gel, for topical use Initial U.S. Approval: 1995Sandoz Inc. | LEO Pharma Inc. | LEO Pharma Manufacturing Italy Srl20211111
c7c5af9c-935e-440d-a625-567936e0bae7These 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: 1995Bayer HealthCare Pharmaceuticals Inc. | Leo Pharma Manufacturing Italy SRL20190723
cc88c1c6-579a-4dbd-b4ae-ffd456903c1eNational Council for Prescription Drug Programs20130401
86050828-5e8f-4bf5-ac59-897918611e0fNational Council for Prescription Drug Programs20120724
63773349-0295-4d56-a72e-0d7cade88ddbFinacea ® (azelaic acid) Gel, 15%Intendis Inc. | Intendis Manufacturing SPA20110412

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD10AXOther anti-acne preparations for topical useATC1-4azelaic acid
FDASPLN0000008841Decreased Protein SynthesisPEhas_peazelaic acid
FDASPLN0000009982Decreased Sebaceous Gland ActivityPEhas_peazelaic acid
MEDRTD003998Dicarboxylic AcidsCHEMhas_ingredientazelaic acid
MEDRTD000152Acne VulgarisDISEASEmay_treatazelaic acid
MEDRTD004342Drug HypersensitivityDISEASEci_withazelaic acid
MEDRTD012393RosaceaDISEASEmay_treatazelaic acid
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moaazelaic acid
MEDRTN0000008841Decreased Protein SynthesisPEhas_peazelaic acid
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_peazelaic acid

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.15 MG/MG (expressed as azelaic acid)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA204637
CODESANDAANDA208011
CODESANDAANDA208724
CODESANDAANDA210549
CODESSNOMEDCT416585000
CODESVUID4016734
NAMESPrescribable Synonymazelaic acid 15 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File