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Azelex azelaic acid .2 g/g Cream — NDC 16110-0869-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Azelex azelaic acid .2 g/g Cream — NDC 16110-869-50 (Billing 16110-0869-50)

by Almirall, LLC · 1 TUBE in 1 CARTON / 50 g in 1 TUBE

This is a package of Azelex azelaic acid .2 g/g Cream from Almirall, LLC, marketed since Sep 2018 and currently FDA-listed.

NDC 16110-0869-50
🏷️ FDA NDC (as labeled) 16110-869-50 billing pads the product segment with a zero
This package
Contains50 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $18.97/unit — full pricing hub ↓
Product page 16110-0869-30 Also comes in: 30 g 16110-869-30
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 16110-869-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
16110 labeler · 869 product · 50 package
Package marketed since
Jul 12, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1611086950 6
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Azelaic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 23, 2026 — CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0731-2026
Class II · Sep 17, 2025 — CGMP Deviations: Market complaints received for gritty texture (grainy) (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0662-2025
Class II · Jul 22, 2024 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0621-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16110-869-50
Product NDC 16110-869
11-digit billing NDC 16110086950
NCPDP billing unit GM — per gram (weight)
RxCUI 1041520, 1043753
UNII F2VW3D43YT
Application # NDA020428
SPL Set ID ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75
Physiologic effect Decreased Protein Synthesis; Decreased Sebaceous Gland Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-09-24
Route CUTANEOUS
Dosage form CREAM
Substance AZELAIC ACID

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90050005103720
GPI class Azelex
GCN Seq No 018229
GCN 62874
HICL code 007471
Ingredient (HICL) Azelaic Acid
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name AZELEX 20% CREAM
FDB brand name Azelex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 018229
  • GCN: 62874
  • GPI-14 (Medi-Span): 90050005103720
  • HICL (First Databank): 007471
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 1041520
Why two NDCs? The FDA registers this code as 16110-869-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 16110-0869-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other anti-acne preparations for topical use class.

Drug family (ATC) Other anti-acne preparations for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AZELEX 20% CREAM Ingredient Azelaic Acid
📖 What it is MedlinePlus · NLM

Azelaic acid gel and foam is used to clear the bumps, lesions, and swelling caused by rosacea (a skin disease that causes redness, flushing, and pimples on the face). Azelaic acid cream is used to treat the pimples and swelling caused by acne. Azelaic acid is in a class of medications called dicarboxylic acids. It works to treat rosacea by decreasing the swelling and redness of the skin. It works to treat acne by killing the bacteria that infect pores and by decreasing production of keratin, a natural substance that can lead to the development of acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Azelaic acid gel, 15% treats the red bumps and pimples of mild to moderate rosacea. It has not been studied for redness alone, without bumps and pimples.
  • It goes on your skin only. For FINACEA Foam, shake it, wash your face with a very mild cleanser, pat dry, and apply a thin layer to your whole face morning and evening. Wash your h...
  • Yes, burning, stinging, itching and dryness are the most common effects, usually in the first few weeks. If irritation becomes severe or doesn't go away, stop and call your doctor.
  • Get help for swelling of your face or eyes, hives or trouble breathing, since these can be signs of an allergic reaction. Also call your doctor if your asthma gets worse.
📖 Read our full Azelaic Acid Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Azelaic Acid — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Azelaic Acid (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $18.97 $948.69 / 50 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
16110-0869-30 16110-869-30 Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE 2019-07-12 — Active
16110-0869-50 You're viewing this 1 TUBE in 1 CARTON / 50 g in 1 TUBE 2019-07-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 50 g in 1 tube.
What NDC number is used to bill for this package of Azelex azelaic acid .2 g/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Azelex .2 g/gthis 16110-0869-50 Almirall, 1 tube — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Azelaic Acid Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 9M64UO4C25
    A synthetic oily substance used as an emollient and texture enhancer in medicines. It helps soften formulations, improves how the medicine spreads or feels on skin, and can act as a lubricant in tablets or capsules.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 1U8KB35S20
    PEG-30 Stearate is a man-made ingredient made by combining polyethylene glycol with stearic acid. It works as an emulsifier and surfactant to help mix oil and water-based ingredients together in the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAlmirall, LLC
Application holderALMIRALL LLC
FDA applicationNDA020428 (NDA)
Labeler code16110
First marketedSep 2018
Product typeHuman Prescription Drug
Portfolio11 products on file

More NDCs from Almirall, LLC labeler code 16110

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

INDICATIONS AND USAGE AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

⏱️ Dosage and Administration 81 words ▾

DOSAGE AND ADMINISTRATION After the skin is thoroughly washed and patted dry, a thin film of AZELEX ® cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX ® cream can vary from person to person and depends on the severity of the acne.

Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.

⛔ Contraindications 17 words ▾

CONTRAINDICATIONS AZELEX ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 49 words ▾

WARNINGS AZELEX ® cream is for dermatologic use only and not for ophthalmic use. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexions, these patients should be monitored for early signs of hypopigmentation.

🤒 Adverse Reactions 107 words ▾

ADVERSE REACTIONS During U.S. clinical trials with AZELEX ® cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects.

There is the potential for experiencing allergic reactions with use of AZELEX ® cream. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.

🤰 Pregnancy 99 words ▾

Pregnancy Teratogenic Effects Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams.

No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients under 12 years of age have not been established.

🧓 Geriatric Use 28 words ▾

Geriatric Use Clinical studies of AZELEX ® cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY The exact mechanism of action of azelaic acid is not known. The following in vitro data are available, but their clinical significance is unknown. Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis.

The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its clinical activity. Electron microscopic and immunohistochemical evaluation of skin biopsies from human subjects treated with AZELEX ® cream demonstrated a reduction in the thickness of the stratum corneum, a reduction in number and size of keratohyalin granules, and a reduction in the amount and distribution of filaggrin (a protein component of keratohyalin) in epidermal layers.

This is suggestive of the ability to decrease microcomedo formation. Pharmacokinetics Following a single application of AZELEX ® cream to human skin in vitro , azelaic acid penetrates into the stratum corneum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application.

Approximately 4% of the topically applied azelaic acid is systemically absorbed. Azelaic acid is mainly excreted unchanged in the urine but undergoes some β-oxidation to shorter chain dicarboxylic acids. The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics.

Azelaic acid is a dietary constituent (whole grain cereals and animal products), and can be formed endogenously from longer-chain dicarboxylic acids, metabolism of oleic acid, and ψ-oxidation of monocarboxylic acids. Endogenous plasma concentration (20 to 80 ng/mL) and daily urinary excretion (4 to 28 mg) of azelaic acid are highly dependent on dietary intake. After topical treatment with AZELEX ® cream in humans, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels.

📦 How Supplied / Storage and Handling 80 words ▾

HOW SUPPLIED AZELEX ® cream is supplied in a closed orifice tube with a white, spiked screwcap in the following sizes: 30 g - NDC 16110-869-30 50 g - NDC 16110-869-50 Storage: Protect from freezing. Store product on its side. Store at 15°-30° C (59°-86° F).

Revised: 02/2024 Distributed by Almirall, LLC, Malvern, PA 19355, U.S.A. © 2019 Almirall. All right reserved. ® marks owned by Almirall, LLC. Made in Italy by LEO Pharma Manufacturing Italy S.r.l., Segrate (Milan), Italy

📋 Description 81 words ▾

DESCRIPTION AZELEX ® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Structural Formula: HOOC-(CH 2 ) 7 -COOH Chemical Name: 1,7-heptanedicarboxylic acid Empirical Formula: C 9 H 16 O 4 Molecular Weight: 188.22 Active Ingredient: Each gram of AZELEX ® contains azelaic acid......... 0.2 g (20% w/w).

Inactive Ingredients: cetearyl octanoate; cetostearyl alcohol; glycerin; glyceryl mono and dipalmitostearate; glyceryl monostearate; isopropyl myristate; PEG-30 stearate; propylene glycol; and purified water. Benzoic acid is present as a preservative.

💬 Information for Patients 132 words ▾

Information for Patients Patients should be told: To use AZELEX ® cream for the full prescribed treatment period. To avoid the use of occlusive dressings or wrappings. To keep AZELEX ® cream away from the mouth, eyes and other mucous membranes.

If it does come in contact with the eyes, they should wash their eyes with large amounts of water and consult a physician if eye irritation persists. If they have dark complexions, to report abnormal changes in skin color to their physician. Due in part to the low pH of azelaic acid, temporary skin irritation (pruritus, burning, or stinging) may occur when AZELEX ® cream is applied to broken or inflamed skin, usually at the start of treatment.

However, this irritation commonly subsides if treatment is continued. If it continues, AZELEX

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General If sensitivity or severe irritation develop with the use of AZELEX ® cream, treatment should be discontinued and appropriate therapy instituted. Information for Patients Patients should be told: To use AZELEX ® cream for the full prescribed treatment period. To avoid the use of occlusive dressings or wrappings.

To keep AZELEX ® cream away from the mouth, eyes and other mucous membranes. If it does come in contact with the eyes, they should wash their eyes with large amounts of water and consult a physician if eye irritation persists. If they have dark complexions, to report abnormal changes in skin color to their physician.

Due in part to the low pH of azelaic acid, temporary skin irritation (pruritus, burning, or stinging) may occur when AZELEX ® cream is applied to broken or inflamed skin, usually at the start of treatment. However, this irritation commonly subsides if treatment is continued. If it continues, AZELEX Carcinogenesis, Mutagenesis, Impairment of Fertility Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity.

Therefore, animal studies to evaluate carcinogenic potential with AZELEX ® cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic. Animal studies have shown no adverse effects on fertility.

Pregnancy Teratogenic Effects Embryotoxic effects were observed in Segment I and Segment II oral studies with rats receiving 2500 mg/kg/day of azelaic acid. Similar effects were observed in Segment II studies in rabbits given 150 to 500 mg/kg/day and in monkeys given 500 mg/kg/day. The doses at which these effects were noted were all within toxic dose ranges for the dams.

No teratogenic effects were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers Equilibrium dialysis was used to assess human milk partitioning in vitro . At an azelaic acid concentration of 25 mcg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk.

However, caution should be exercised when AZELEX ® cream is administered to a nursing mother. Pediatric Use Safety and effectiveness in pediatric patients under 12 years of age have not been established. Geriatric Use Clinical studies of AZELEX ® cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🍼 Nursing Mothers 95 words ▾

Nursing Mothers Equilibrium dialysis was used to assess human milk partitioning in vitro . At an azelaic acid concentration of 25 mcg/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution was 1.0, indicating that passage of drug into maternal milk may occur. Since less than 4% of a topically applied dose is systemically absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk.

However, caution should be exercised when AZELEX ® cream is administered to a nursing mother.

🧬 Pharmacokinetics 186 words ▾

Pharmacokinetics Following a single application of AZELEX ® cream to human skin in vitro , azelaic acid penetrates into the stratum corneum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application. Approximately 4% of the topically applied azelaic acid is systemically absorbed.

Azelaic acid is mainly excreted unchanged in the urine but undergoes some β-oxidation to shorter chain dicarboxylic acids. The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics. Azelaic acid is a dietary constituent (whole grain cereals and animal products), and can be formed endogenously from longer-chain dicarboxylic acids, metabolism of oleic acid, and ψ-oxidation of monocarboxylic acids.

Endogenous plasma concentration (20 to 80 ng/mL) and daily urinary excretion (4 to 28 mg) of azelaic acid are highly dependent on dietary intake. After topical treatment with AZELEX ® cream in humans, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 94 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Azelaic acid is a human dietary component of a simple molecular structure that does not suggest carcinogenic potential, and it does not belong to a class of drugs for which there is a concern about carcinogenicity. Therefore, animal studies to evaluate carcinogenic potential with AZELEX ® cream were not deemed necessary. In a battery of tests (Ames assay, HGPRT test in Chinese hamster ovary cells, human lymphocyte test, dominant lethal assay in mice), azelaic acid was found to be nonmutagenic.

Animal studies have shown no adverse effects on fertility.

📄 Package Label / Principal Display Panel 60 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Carton Label 30 gram Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Carton Label 50 gram Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 16110-869-30 - 30 gram Tube Label 30 gram Tube Label

PRINCIPAL DISPLAY PANEL - NDC: 16110-869-50 - 50 gram Tube Label 50 gram Tube Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Azelex — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Azelex. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$373.3K
Claims incl. refills
502
Beneficiaries
410
Spend / beneficiary
$910.58
Spend / claim
$743.70
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Almirall, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (16110-0869-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Almirall, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 16110-0833-10 · Almirall, 16110-0915-30 · Almirall, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.