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Adapalene Gel USP, 0.3% 3 mg/g Gel — NDC 72162-2295-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Adapalene Gel USP, 0.3% 3 mg/g Gel — NDC 72162-2295-4 (Billing 72162-2295-04)

by Bryant Ranch Prepack · 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP

This is a package of Adapalene Gel USP, 0.3% 3 mg/g Gel from Bryant Ranch Prepack, marketed since May 2023 and currently FDA-listed.

NDC 72162-2295-04
🏷️ FDA NDC (as labeled) 72162-2295-4 billing pads the package segment with a zero
This package
Contains45 g in 1 bottle, pump Pack sizes2 compare ↓
Also priced by: Part D plans $0.9380/unit — full pricing hub ↓
Product page 72162-2295-02 Also comes in: 45 g 72162-2295-2
Rx only Generic 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 →

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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 72162-2295-4 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72162 labeler · 2295 product · 4 package
Package marketed since
Apr 30, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7216222954 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72162-2295-4
Product NDC 72162-2295
11-digit billing NDC 72162229504
NCPDP billing unit GM — per gram (weight)
RxCUI 722111
UNII 1L4806J2QF
Application # ANDA200298
SPL Set ID c448eab6-c054-4c8b-9319-556b7e1be3cf
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-05
Route TOPICAL
Dosage form GEL
Substance ADAPALENE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 068878
GCN 31773
HICL code 011233
Ingredient (HICL) Adapalene
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L9
Therapeutic class — intermediate (HIC2) Dermatologic Preparations,Miscellaneous
HIC3 code L9B
Therapeutic class — specific (HIC3) Vitamin A Derivatives
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name ADAPALENE 0.3% GEL PUMP
FDB brand name Adapalene
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 068878
  • GCN: 31773
  • HICL (First Databank): 011233
  • AHFS class code: 84:28.00.00
  • RxCUI (RxNorm): 722111
Why two NDCs? The FDA registers this code as 72162-2295-4 — a 5-4-1 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 package segment → 72162-2295-04. 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 Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne
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 ADAPALENE 0.3% GEL PUMP Ingredient Adapalene
📗 Our plain-language guide HelloPharmacist
  • It treats acne vulgaris, the common type of acne. Some products are labeled for ages 12 and up. Ask a doctor before using it in younger children.
  • Use it once a day, usually in the evening, on clean, dry skin. Apply a thin layer to the whole affected area and keep it away from your eyes, lips and inside of your mouth or nose....
  • Give it about 8 to 12 weeks. Acne can seem to flare in the early weeks, which is not a reason to stop. If you see no improvement after 12 weeks, talk to your prescriber.
  • Redness, dryness, peeling and some burning or stinging are the most common, especially in the first month. They are usually mild to moderate and often ease. A moisturizer can help....
📖 Read our full Adapalene guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $0.9380 $42.21 / 45 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
72162-2295-02 72162-2295-2 Main listing 1 TUBE in 1 CARTON / 45 g in 1 TUBE 2024-04-30 — Active
72162-2295-04 You're viewing this 1 BOTTLE, PUMP in 1 CARTON / 45 g in 1 BOTTLE, PUMP 2024-04-30 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 45 g in 1 bottle, pump.
What NDC number is used to bill for this package of Adapalene Gel USP, 0.3% 3 mg/g Gel?
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
adapalene 3 mg/g 00472-0126-45 Actavis 1 tube $0.504 AB Availability likely —
Adapalene Gel USP, 0.3% 3 mg/g 21922-0051-06 Encube 1 tube $0.504 AB Availability likely —
Adapalene 3 mg/g 51672-1377-06 Sun 1 tube $0.504 AB Availability likely —
Adapalene 3 mg/g 68308-0666-25 Mayne 1 tube $0.504 AB Availability likely —
Differin 3 mg/g 00299-5918-02 Galderma 2 g — AB Discontinued —
Adapalene 3 mg/g 46708-0549-15 Alembic 1 tube — AB FDA listed —
Adapalene 3 mg/g 62332-0549-15 Alembic 1 tube — AB FDA listed —
Adapalene Gel USP, 0.3% 3 mg/gthis 72162-2295-04 Bryant 1 bottle — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 Adapalene 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerBryant Ranch Prepack
Application holderENCUBE ETHICALS PVT LTD
FDA applicationANDA200298 (ANDA)
Labeler code72162
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 72162

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 46 words ▾

1 INDICATIONS AND USAGE ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ADAPALENE Gel, 0.3% is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

⏱️ Dosage and Administration 164 words ▾

2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes.

A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel,0.3%. Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be reevaluated.

For topical use only. Not for ophthalmic, oral or intravaginal use. • Wash affected areas gently with a non-medicated soap. ( 2 ) • Apply a thin film of adapalene gel, to the entire face and other affected areas of the skin once daily in the evening.

( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 22 words ▾

3 DOSAGE FORMS AND STRENGTHS Each gram of adapalene gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. Gel, 0.3%

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS Adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% [see WARNINGS AND PRECAUTIONS (5.1) ]. Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel,0.3%

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Allergic/ Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis, angioedema, urticaria, and pruritis. Discontinue adapalene gel in the event of an allergic/hypersensitivity reaction. ( 5.1 ) • Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps.

Wear sunscreen when sun exposure cannot be avoided ( 5.2 ). • Local Cutaneous Reactions: Erythema, scaling, dryness. and stinging/burning were reported with use of adapalene gel. Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. ( 5.3 ).

5.1Allergic/ Hypersensitivity Reactions Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using Adapalene gel, 0.3% and seek medical attention if experiencing allergic or anaphylactoid/ anaphylactic reactions during treatment.

5.2Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of adapalene gel, 0.3%. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene gel, 0.3%.

5.3Local Cutaneous Reactions Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/ burning were reported with use of adapalene gel, 0.3%. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of adapalene gel, 0.3% or discontinue use.

Avoid application to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene. As adapalene gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most frequently reported (≥1%) adverse reactions were dry skin, skin discomfort, pruritus, desquamation, and sunburn. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne subjects who used Adapalene gel, 0.3% once daily for 12 weeks. Of the subjects who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter.

The incidence of local cutaneous irritation with Adapalene gel, 0.3% from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene gel Incidence of Local Cutaneous Irritation with Adapalene gel, 0.3% (N = 253*) Maximum Severity Scores Higher Than Baseline Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning / Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%) * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.

Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel Adapalene Gel, 0.3% Vehicle Gel N = 258 N = 134 Related* Adverse Reactions Dry Skin Skin Discomfort 57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%) 6 (4.5%) 2 (1.5%) 0 (0.0%) 0 (0.0%) * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related The following adverse reactions occurred in less than 1 % of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits_ during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.

Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.

Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).

8.2Lactation Risk Summary There are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, adapalene is present in rat milk with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk ( see Clinical Considerations ). The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene gel, 0.3% and any potential adverse effects on the breastfed child from adapalene gel, 0.3% or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use adapalene gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding.

Avoid application of adapalene gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child.

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.

8.5Geriatric Use Clinical studies of adapalene gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from clinical trials with Adapalene Gel, use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits_ during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.

Data Animal Data No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD based on a mg/m 2 comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m 2 comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.

Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12.

🧓 Geriatric Use 42 words ▾

8.5Geriatric Use Clinical studies of adapalene gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

🆘 Overdosage 24 words ▾

10 OVERDOSAGE Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel,0.3%.

12.3Pharmacokinetics Systemic exposure of adapalene following topical application of adapalene gel was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of adapalene gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max , of 0.553 ± 0.466 ng/mL on Day 10 of treatment.

The mean AUC 0-24hr was 8.37 ± 8.46 ng.h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.

Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks.

Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ= 0.25 ng/mL) of the method were found.

One of these samples was taken at Week 12 from a male subject treated with adapalene gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.

🧬 Mechanism of Action 61 words ▾

12.1Mechanism of Action Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes. However, the significance of these findings with regard to the mechanism of action of adapalene for the treatment of acne is unknown.

📦 How Supplied / Storage and Handling 67 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Adapalene Gel, USP,0.3% is supplied in the following size. NDC 72162-2295-2: 45 g in a TUBE NDC 72162-2295-4: 45 g in a PUMP Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 100 words ▾

11 DESCRIPTION Adapalene Gel USP, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 980, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid.

It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C 28 H 28 O 3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using Adapalene gel, 0.3% should receive the following information and instructions. 1. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non- medicated soap.

2. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes 3. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.

4. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. 5.

Wax depilation should not be performed on treated skin due to the potential for skin erosions 6. Minimize exposure to sunlight including sunlamps Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. 7.

Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. 8. This product is for external use only.

9. Lactation: Use Adapalene gel. 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding.

Avoid application of Adapalene gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [See Use in Specific Populations, Lactation (8.2) ]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Systemic exposure of adapalene following topical application of adapalene gel was evaluated in a clinical trial. Sixteen acne subjects were treated once daily for 10 days with 2 grams of adapalene gel, 0.3% applied to the face, chest and back, corresponding to approximately 2 mg/cm 2 . Fifteen subjects had quantifiable (LOQ = 0.1 ng/mL) adapalene levels resulting in a mean C max , of 0.553 ± 0.466 ng/mL on Day 10 of treatment.

The mean AUC 0-24hr was 8.37 ± 8.46 ng.h/mL as determined in 15 of the 16 subjects on Day 10. The terminal apparent half-life, determined in 15 of 16 subjects, ranged from 7 to 51 hours, with a mean of 17.2 ± 10.2 hours. Adapalene was rapidly cleared from plasma and was not detected 72 hours after the last application for all but one subject.

Exposure of potential circulating metabolites of adapalene was not measured. Excretion of adapalene appears to be primarily by the biliary route. In another clinical trial in subjects with moderate to moderately severe acne, Adapalene gel, 0.3% or Adapalene Gel, 0.1% was applied to the face and optionally to the trunk, once daily for 12 weeks.

Seventy-eight (78) subjects had plasma adapalene levels evaluated at Weeks 2, 8, and 12. Of the 209 plasma samples analyzed, adapalene concentrations were below the limit of detection (LOD = 0.15 ng/mL) of the method in all samples but three. For the three samples, traces of adapalene below the limit of quantification (LOQ= 0.25 ng/mL) of the method were found.

One of these samples was taken at Week 12 from a male subject treated with adapalene gel, 0.3% who treated the face and the trunk for eight weeks (thereafter, only the face was treated). The second and third samples were from the Week 2 and 12 visits of a female subject treated with Adapalene Gel, 0.1% who treated only the face for 12 weeks. In this study, the average daily usage of product was 1 g/day.

🧬 Pharmacodynamics 12 words ▾

12.2Pharmacodynamics Clinical pharmacodynamic studies have not been conducted for Adapalene Gel,0.3%.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The safety and efficacy of once daily use of adapalene gel, 0.3% for treatment of acne vulgaris were assessed in one 12 week, multi­ center, controlled, clinical trial, conducted in a total of 653 subjects 12 to 52 years of age with acne vulgaris of mild to moderate severity. All female subjects of child-bearing potential enrolled in the trial were required to have a negative urine pregnancy test at the beginning of the trial and were required to practice a highly effective method of contraception during the trial.

Female subjects who were pregnant, nursing or planning to become pregnant were excluded from the trial. Subjects enrolled in the trial were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%). An equal number of males (49.5%) and females (50.5%) enrolled.

Success was defined as "Clear'" or "Almost Clear" in the Investigator's Global Assessment (IGA). The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table: Table 3: Clinical study primary efficacy results at Week 12 Adapalene Gel, 0.3% Adapalene Gel, 0.1% Vehicle Gel N = 258 N = 261 N = 134 IGA Success Rate 53 (21%) 41 (16%) 12 (9%) Inflammatory Lesions Mean Baseline Count Mean Absolute (%) Reduction 27.7 14.4 (51.6%) 28.1 13.9 (49.7%) 27.2 11.2 (40.7%) Non-inflammatory Lesions Mean Baseline Count Mean Absolute(%) Reduction 39.4 16.3 (39.7%) 41.0 15.2 (35.2%) 40.0 10.3 (27.2%) Total Lesions Mean Baseline Count Mean Absolute(%) Reduction 67.1 30.6 (45.3) 69.1 29.0 (41.8%) 67.2 21.4 (33.7%)

🧪 Nonclinical Toxicology 176 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis , Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison.

In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 173 words ▾

13.1Carcinogenesis, Mutagenesis , Impairment of Fertility No carcinogenicity, genotoxicity, or impairment of fertility studies were conducted with Adapalene gel, 0.3%. Carcinogenicity studies with adapalene were conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m 2 /day) and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m 2 /day). The highest dose levels are 3.2 (mice) and 2.4 (rats) times the MRHD based on a mg/m 2 comparison.

In the rat study, an increased incidence of benign and malignant pheochromocytomas reported in the adrenal medulla of male rats was observed. Adapalene was not mutagenic or genotoxic in vitro (Ames test, Chinese hamster ovary cell assay, or mouse lymphoma TK assay) or in vivo (mouse micronucleus test). In rat oral studies, 20 mg/kg/day adapalene (32 times the MRHD based on a mg/m 2 comparison) did not affect the reproductive performance and fertility of F 0 males and females or the growth, development, or reproductive function of F 1 offspring.

📄 Patient Package Insert ~3 min read ▾

Patient Information Adapalene Gel, [a-DAP-a-leen] Important: For use on the skin only (topical). Do not use adapalene gel, 0.3% in or on your mouth, eyes or vagina. Read this Patient Information that comes with Adapalene Gel, 0.3% before you start using it and each time you get a refill.

There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about adapalene gel, 0.3% talk with your doctor or pharmacist.

What is Adapalene gel, 0.3%? Adapalene Gel, 0.3% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 12 years of age and older. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if adapalene gel, 0.3% is safe and effective in children younger than 12 years of age or in people 65 years of age and older. Who should not use Adapalene Gel 0.3%? Do not use Adapalene Gel, 0.3% if you: • are allergic to adapalene or any of the ingredients in adapalene gel, 0.3%.

See the end of this Patient Information for a complete list of ingredients in adapalene gel, 0.3%. What should I tell my doctor before using Adapalene Gel, 0.3%? Before you use Adapalene Gel, 0.3% tell your doctor if you: have other skin problems, including cuts or sunburn have any other medical conditions are pregnant or planning to become pregnant.

It is not known if Adapalene Gel, 0.3%, can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Adapalene Gel, 0.3% passes into your breast milk and if it can harm your baby.

Talk to your doctor about the best way to feed your baby if you use Adapalene Gel, 0.3%. Tell your doctor about all the medicines you take , including prescription and non­-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use any other medicine for acne.

Using adapalene gel, 0.3% with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use Adapalene gel, 0.3%? • Use adapalene gel, 0.3% exactly as your doctor tells you to use it. Adapalene gel, 0.3% is for skin use only. Do not use adapalene gel in or on your mouth, eyes, or vagina. • Apply adapalene gel, 0.3% 1 time a day.

Do not use more adapalene gel, 0.3% than you need to cover the treatment area. Using too much adapalene gel, 0.3% or using it more than 1 time a day may increase your chance of skin irritation. Applying adapalene gel, 0.3%: • Wash the area where adapalene gel, 0.3% will be applied with a soap that does not contain a medicine and pat dry. • Adapalene Gel, 0.3% comes in a tube and a pump.

If you have been prescribed the: o Tube: Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas. o Pump: Depress the pump to dispense a small amount of adapalene gel, 0.3% and spread a thin layer over the entire face and any other affected area. What should I avoid while using Adapalene Gel, 0.3%? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene Gel, 0.3% can make your skin sensitive to sun and the light from tanning beds and sunlamps.

You should wear sunscreen and wear hat and clothes that cover the areas treated with adapalene gel, 0.3% if you have to be in sunlight. • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin. • You should avoid applying adapalene gel, 0.3% to cuts, abrasions and sunburned skin. • You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol. • You should avoid the use of… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 10 words ▾

Adapalene 0.3% Gel Tube Adapalene 0.3% Gel Pump Label Label

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

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 Bryant Ranch Prepack. 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 (72162-2295-02). 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?
Bryant Ranch Prepack 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.
← 72162-2294-02 · Bryant 72162-2296-02 · Bryant →
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.