Home › NDC Lookup › Ingredients › Tretinoin › 69238-2323-01
🧴image loading
(from DailyMed)

Tretinoin .8 mg/g Gel — NDC 69238-2323-1 (Billing 69238-2323-01)

by Amneal Pharmaceuticals NY LLC · 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP

This is a package of Tretinoin .8 mg/g Gel from Amneal Pharmaceuticals NY LLC, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 69238-2323-01
🏷️ FDA NDC (as labeled) 69238-2323-1 billing pads the package segment with a zero
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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69238-2323-1
Product NDC 69238-2323
11-digit billing NDC 69238232301
RxCUI 1488045
UNII 5688UTC01R
UPC 0369238232318
Application # ANDA217497
SPL Set ID 4b6006e3-f7a4-4823-8217-3e5b0f7e58d9
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 2026-05-15
Route TOPICAL
Dosage form GEL
Substance TRETINOIN
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1488045
Why two NDCs? The FDA registers this code as 69238-2323-1 — 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 → 69238-2323-01. 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, Retinoids for cancer treatment
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

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. Creams, gels and lotions treat acne, and Renova eases fine facial wrinkles. The capsules treat a blood cancer called acute promyelocytic leukemia.
  • Wash the area, pat dry, and apply a thin layer once daily, usually in the evening. Keep it away from your eyes, mouth, nose creases and mucous membranes. More does not work faster...
  • Mild warmth or stinging, redness and peeling are common. If it becomes severe, call your prescriber, who may have you use less or pause. Acne can seem to flare early on, which is n...
  • What side effects should I expect on the skin?
📖 Read our full Tretinoin guide →
1
Nutrient depletion considerations

Tretinoin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Tretinoin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $8.96 $447.96 / 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
69238-2323-01 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP 2026-05-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tretinoin .8 mg/g 21922-0043-40 Encube 1 bottle $11.465 AB Availability likely —
Tretinoin (Microsphere) .8 mg/g 68308-0777-50 Mayne 1 bottle $11.465 AB Availability likely —
Retin-A MICRO .8 mg/g 00187-5148-02 Bausch 24 tubes — — FDA listed —
Tretinoin .8 mg/g 68682-0515-95 Oceanside 1 bottle — — FDA listed —
Tretinoin .8 mg/gthis 69238-2323-01 Amneal 1 bottle — AB FDA listed —
Tretinoin .8 mg/g 72162-2303-02 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life 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 7BK5G69305
    A synthetic polymer made from glycol and acrylic compounds. It's used as a binder and film-former to hold tablet ingredients together and create a protective coating on the tablet surface.
  • UNII 196OC77688
    A synthetic plastic polymer used as a film-coating material on tablets and capsules. It helps protect the medication, control how fast it dissolves, and improve appearance.
  • UNII 0057334FAB
    A synthetic compound derived from glucose that combines water-repelling and water-attracting properties. It works as an emulsifier to help blend oil and water-based ingredients, and may also function as a thickener in creams and lotions.
  • 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 O4446S9CRA
    A synthetic oily liquid made from propylene glycol and fatty acids. It acts as a solvent and emulsifier to help dissolve or mix ingredients, and improves how the medicine spreads or absorbs in the body.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

15 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

LabelerAmneal Pharmaceuticals NY LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA217497 (ANDA)
Labeler code69238
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio372 products on file
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 💬 Patient Medication Information 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Tretinoin gel (microsphere)is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. (1)

⏱️ Dosage and Administration 198 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. Prior to tretinoin gel (microsphere) use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry.

When applying tretinoin gel (microsphere), keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. Apply a thin layer of tretinoin gel (microsphere), 0.08% to skin where acne lesions appear (cover the entire affected area), once daily in the evening. Do not apply more than a thin layer [see Warning and Precautions (5.1) ] .

Improvements in acne lesions may be noticed after two weeks of tretinoin gel (microsphere) therapy, but more than seven weeks of therapy may be needed for sustained benefit. If tretinoin gel (microsphere) was temporarily discontinued due to local adverse reactions, tretinoin gel (microsphere) therapy may be resumed upon resolution of local adverse reactions. For topical use only.

Not for oral, ophthalmic, or intravaginal use. (2) Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes. (2) Apply a thin layer of tretinoin gel (microsphere) to skin where acne lesions appear (cover the entire affected area) once daily in the evening.

(2)

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Tretinoin gel, USP (microsphere), 0.08% is a white to very pale-yellow opaque gel. Tretinoin gel, USP is available in one strength: 0.08%. Each gram of tretinoin gel, USP (microsphere), 0.08%, contains 0.8 mg of tretinoin, USP. Gel, 0.08% (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Local Skin Irritation: Tretinoin gel can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging (5.1) Avoid use on eczematous skin or during weather extremes, such as severe wind or cold. To reduce the risk of local skin irritation, wash the treated skin gently, using a mild, non-medicated soap, avoid washing the treated skin too often or scrubbing it hard when washing, and apply a topical moisturizer. If severe local skin irritation occurs, discontinue use temporarily or permanently.

Initial Worsening of Inflammatory Acne Vulgaris: During the early weeks of tretinoin gel treatment, an apparent exacerbation of inflammatory lesions may occur. If tretinoin gel is tolerated, this should not be considered a reason to discontinue therapy. (5.2) Photosensitivity: Tretinoin gel can cause photosensitivity.

Advise patients to avoid or minimize unnecessary exposure to UV light, including sunlight and sunlamps. Advise patients to use sunscreen (SPF ≥15) and sun-protective clothing if UV light exposure cannot be avoided. Avoid use on sunburn skin.

(5.3)

5.1Local Skin Irritation Tretinoin gel can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging [see Adverse Reactions (6.1) ] . Use of tretinoin gel in greater than the recommended dosage (more frequent than once daily application or excessive application) will not result in more rapid or improved acne results and may result in marked redness, peeling, or discomfort. Tretinoin has been reported to cause severe local skin irritation on eczematous skin.

Weather extremes, such as severe wind or cold, may increase the risk of skin irritation in patients using tretinoin gel. To reduce the risk of local skin irritation, instruct tretinoin gel treated patients to: Avoid use of tretinoin gel in areas affected by eczema. Minimize or avoid use of tretinoin gel with weather extremes.

Wash the treated skin gently, using a mild, non-medicated soap, pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing. Tretinoin gel is not recommended with concomitant use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, or lime peels. Apply a topical moisturizer.

Advise patients that concomitant use of topical over the counter (OTC) acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with tretinoin gel may increase the risk for local skin irritation including dryness, erythema, and peeling. Consider withholding the use of topical OTC acne products if signs of skin irritation develop. Advise patients to allow the skin irritation effects of the topical OTC acne products to subside before initiation of tretinoin gel treatment.

If severe local skin irritation occurs, discontinue tretinoin gel use temporarily or permanently. Efficacy of tretinoin gel at reduced frequencies of application has not been established.

5.2Initial Worsening of Inflammatory Acne Vulgaris During the early weeks of tretinoin gel treatment, an apparent exacerbation of inflammatory acne vulgaris lesions may occur. If tretinoin gel is tolerated, initial worsening of inflammatory acne vulgaris lesions should not be considered a reason to discontinue therapy.

5.3Photosensitivity Tretinoin gel can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using tretinoin gel. Advise patients with sunburn to not use tretinoin gel until the sunburn fully recovers.

Advise patients, especially those who may be required to have extended periods of UV light exposure (e.g., due to occupation or sports), those with inherent sensitivity to the sun, or those using drugs that cause photosensitivity, to use sun protection daily in the… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 reaction 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. Tretinoin gel, 0.1% The safety of tretinoin gel, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2). A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received tretinoin gel, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks.

Mean age was 19 years (range 11 to 40) and 55% were female [see Clinical Studies (14.1) ] . Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] . In Studies 1 and 2, subjects treated with tretinoin gel, 0.1% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1)] .

During the 12-week treatment period, no more than 3% of tretinoin gel, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of tretinoin gel, 0.1%-treated subjects discontinued treatment due to cutaneous irritation. Of these 14 subjects, four had severe cutaneous irritation after 3 to 5 days of treatment, with blistering in one subject. Tretinoin gel, 0.04% The safety of tretinoin gel, 0.04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4).

A total of 451 subjects with acne vulgaris were treated in Studies 3 and 4 in which 225 subjects received tretinoin gel, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks. Mean age was 19 years (range 11 to 49) and 57% were female [see Clinical Studies (14.2) ] . Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] .

In Studies 3 and 4, subjects treated with tretinoin gel, 0.04% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1) ] . Approximately half of the 225 subjects in the tretinoin gel, 0.04%-treated group had cutaneous irritation at Week 2. Of the subjects who experienced cutaneous irritation, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe).

Less than 10% of tretinoin gel, 0.04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2. In Studies 3 and 4, during the 12-week treatment period, the majority of tretinoin gel, 0.04%-treated subjects experienced cutaneous irritation (mild, moderate, or severe), of which, 1% (2/225) of subjects had cutaneous irritation scores indicative of a severe irritation and 1.3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another.

Tretinoin gel, 0.04% and 0.1% In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with tretinoin gel, 0.04% (n=78) or 0.1% (n=78) topically once daily. In this trial, the most freque… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . In animal reproduction studies with pregnant rats, alterations in the vertebrae and ribs of offspring were observed with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 5 to 10 times the maximum recommended human dose (MRHD).

In animal reproduction studies with pregnant rabbits, fetal malformations, such as domed head and hydrocephaly, were observed in the offspring with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 10 to 19 times the MRHD [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 defect, loss, or other adverse outcomes.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Data Human Data: Published data from prospective observational studies and retrospective cohort studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including potential misclassification of exposure, small sample size and in some cases, lack of physical exam by an expert in birth defects.

Animal Data: For purposes of comparison of the animal exposure to systemic human exposure, the MRHD applied topically is defined as 1 gram of tretinoin gel microsphere, 0.1%, applied daily to a 60 kg person (0.017 mg tretinoin/kg body weight). Pregnant rats were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 6 to 15. Alterations were seen in the vertebrae and ribs of the affected offsprings at 0.5 mg/kg/day tretinoin, 5 to 10 times the MRHD based on body surface area (BSA) comparison.

Pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 7 to 19. Doses were administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. Increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species were observed at doses of 0.5 and 1 mg/kg/day.

Similar malformations were not observed in the offspring at 0.2 mg/kg/day, 4 times the MRHD based on BSA comparison. In a second rabbit study, pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.5 or 1 mg/kg/day tretinoin on gestation days 7 to 19. Doses were administered topically for six hours per day while pregnant rabbits were restrained in stocks to prevent ingestion.

The offspring of pregnant rabbits exposed to 0.5 or 1 mg/kg/day tretinoin did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the MRHD based on BSA comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the MRHD based on BSA comparison). Malformations (shortened or kinked tail) were observed in the offspring of pregnant rats treated with topical tretinoin at doses greater than 1 mg/kg/day during the period of organogenesis (10 times the MRHD based on BSA comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported in offspring when 10 mg/kg/day was topically applied to pregnant rats during the period of organogenesis.

Supernumerary ribs have been a consistent finding in newborn rats when dams were treated topically or orally with retinoids. Oral… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . In animal reproduction studies with pregnant rats, alterations in the vertebrae and ribs of offspring were observed with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 5 to 10 times the maximum recommended human dose (MRHD).

In animal reproduction studies with pregnant rabbits, fetal malformations, such as domed head and hydrocephaly, were observed in the offspring with daily topical dosing of 0.1% tretinoin gel (microsponge) during organogenesis at 10 to 19 times the MRHD [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 defect, loss, or other adverse outcomes.

In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Data Human Data: Published data from prospective observational studies and retrospective cohort studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including potential misclassification of exposure, small sample size and in some cases, lack of physical exam by an expert in birth defects.

Animal Data: For purposes of comparison of the animal exposure to systemic human exposure, the MRHD applied topically is defined as 1 gram of tretinoin gel microsphere, 0.1%, applied daily to a 60 kg person (0.017 mg tretinoin/kg body weight). Pregnant rats were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 6 to 15. Alterations were seen in the vertebrae and ribs of the affected offsprings at 0.5 mg/kg/day tretinoin, 5 to 10 times the MRHD based on body surface area (BSA) comparison.

Pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.2, 0.5, and 1 mg/kg/day tretinoin on gestation days 7 to 19. Doses were administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. Increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species were observed at doses of 0.5 and 1 mg/kg/day.

Similar malformations were not observed in the offspring at 0.2 mg/kg/day, 4 times the MRHD based on BSA comparison. In a second rabbit study, pregnant rabbits were treated with 0.1% tretinoin gel (microsponge) at daily dermal doses of 0.5 or 1 mg/kg/day tretinoin on gestation days 7 to 19. Doses were administered topically for six hours per day while pregnant rabbits were restrained in stocks to prevent ingestion.

The offspring of pregnant rabbits exposed to 0.5 or 1 mg/kg/day tretinoin did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the MRHD based on BSA comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the MRHD based on BSA comparison). Malformations (shortened or kinked tail) were observed in the offspring of pregnant rats treated with topical tretinoin at doses greater than 1 mg/kg/day during the period of organogenesis (10 times the MRHD based on BSA comparison). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported in offspring when 10 mg/kg/day was topically applied to pregnant rats during the period of organogenesis.

Supernumerary ribs have been a consistent finding in newborn rats when dams were treated topically or orally with retinoids. Oral administration of tretinoin du… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 56 words ▾

8.4Pediatric Use The safety and effectiveness of tretinoin gel for topical application for the treatment of acne vulgaris have been established in pediatric patients aged 12 years and older [see Clinical Studies (14) ] . The safety and effectiveness of tretinoin gel have not been established in pediatric patients younger than 12 years of age.

🧓 Geriatric Use 56 words ▾

8.5Geriatric Use Clinical trials of tretinoin gel did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger adult subjects. Acne vulgaris is largely a disease of pediatric and young adult patients. Clinical studies of tretinoin gel did not include patients 65 years of age and older.

🆘 Overdosage 41 words ▾

10 OVERDOSAGE Oral ingestion of large amounts of tretinoin gel may lead to the same adverse reactions as those associated with excessive oral intake of Vitamin A. Consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for overdose recommendations.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARß, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors and/or other mechanisms. The exact mechanism of action of topical tretinoin for treatment of acne vulgaris is unknown. Current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation.

Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.2Pharmacodynamics The pharmacodynamics of tretinoin gel is unknown.

12.3Pharmacokinetics Absorption Tretinoin is a metabolite of Vitamin A. Percutaneous absorption, as determined by the cumulative excretion of radiolabeled drug into urine and feces, was assessed in 44 healthy males and females after single and repeated daily tretinoin applications up to 28 days of 500 mg of a 0.1% tretinoin gel product. In this assessment, estimates of in vivo bioavailability, mean (SD) were 0.82 (0.11)% and 1.41 (0.54)%, for single and multiple daily topical applications, respectively.

The plasma concentrations of tretinoin and its metabolites, 13- cis -retinoic acid, all- trans -4-oxo-retinoic acid, and 13- cis -4-oxo-retinoic acid, generally ranged from 1 to 3 ng/mL and were essentially unaltered after either single or multiple daily applications of tretinoin gel, 0.1%, relative to baseline levels. Clinical pharmacokinetic studies have not been performed with tretinoin gel, 0.08%, 0.06% and 0.04%.

🧬 Mechanism of Action 106 words ▾

12.1Mechanism of Action Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARß, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors and/or other mechanisms. The exact mechanism of action of topical tretinoin for treatment of acne vulgaris is unknown. Current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation.

Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tretinoin gel USP (microsphere), 0.08% is a white to very pale-yellow opaque gel; free from lumps and foreign matters filled in a black colored pump. Tretinoin gel USP (microsphere), 0.08%, is supplied in 50 gram pump (NDC 69238-2323-1). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store pump upright. Keep out of reach of children.

📋 Description 132 words ▾

11 DESCRIPTION Chemically, tretinoin, USP is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin, USP is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin, USP has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following chemical structure: Tretinoin gel, USP (microsphere) is for topical use.

Each gram of tretinoin gel USP (microsphere), 0.08%, contains 0.8 mg of tretinoin, USP. The formulation uses copolymer of methyl methacrylate and ethylene glycol dimethacrylate crosspolymer (microspheres system) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. Other components consist of benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and PPG-18/18 dimethicone, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, purified water, sorbic acid, trolamine, and propylene glycol dicaprylate/dicaprate.

Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Administration Instruct the patient to [see Dosage and Administration (2) ] : Thoroughly cleanse treatment area(s) with a mild, non-medicated cleanser then pat the skin dry prior to application of tretinoin gel. Avoid contact with eyes, mouth, paranal creases of nose, and mucous membranes when applying tretinoin gel (microsphere).

Apply a thin layer of tretinoin gel (microsphere) to cover the affected area(s). Local Skin Irritation: Advise the patient that use of tretinoin gel (microsphere) greater than the recommended dosage will not result in more rapid of improved acne results and may result in marked redness, peeling or discomfort [see Warnings and Precautions (5.1) ] . To reduce the risk of local skin irritation, advise the patient to: Minimize or avoid use of tretinoin gel (microsphere) during weather extremes, such as severe wind or cold.

Wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing. Not use medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, and lime peels while using tretinoin gel (microsphere). Apply a topical moisturizer when using tretinoin gel (microsphere).

Advise the patient that concomitant use of topical OTC acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with tretinoin gel (microsphere) may increase the risk of local skin irritation. Advise the patient to withhold the use of topical OTC acne products if signs of skin irritation develop. Advise the patient to allow the skin irritation effects of the topical OTC acne products to subside before initiation of tretinoin gel (microsphere) [see Warning and Precautions (5.1) ] .

Photosensitivity Advise the patient to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using tretinoin gel (microsphere). Advise the patient to not use tretinoin gel on sunburn skin. Advise the patient to use sun protection in the form of sunscreen (SPF ≥15) and sun-protective clothing if UV exposure cannot be avoided [see Warnings and Precautions (5.3) ] .

Lactation Advise the female patient to use tretinoin gel (microsphere) on the smallest area of skin with acne vulgaris and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, instruct the patient who is breastfeeding not to apply tretinoin gel (microsphere) directly to the nipple and areola [see Use in Specific Populations (8.2)] . Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

04-2026-01

💬 Patient Medication Information ~3 min read ▾

Patient Information Tretinoin (tret’ i noyn) Gel, USP(microsphere) for topical use Important information: Tretinoin gel (microsphere) is for use on skin (topical use) only. Keep tretinoin gel (microsphere) away from your eyes, mouth, vagina, or the corners of your nose. What is tretinoin gel (microsphere)?

Tretinoin gel (microsphere) is a prescription medicine used on the skin (topical) to treat acne in adults and children 12 years of age and older. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if tretinoin gel (microsphere) is safe and effective in children under 12 years of age.

Before using tretinoin gel (microsphere), tell your healthcare provider about all of your medical conditions, including if you: have a skin condition called eczema. have a sunburn. You should not use tretinoin gel (microsphere) until your skin has healed. are pregnant or plan to become pregnant. It is not known if tretinoin gel (microsphere) will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if tretinoin passes into your breast milk. If you breastfeed during treatment with tretinoin gel (microsphere), use tretinoin gel (microsphere) on the smallest area of the skin with acne and for the shortest time possible. Do not apply tretinoin gel (microsphere) directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use any skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Using these topical skin products may increase the irritation of your skin when used with tretinoin gel (microsphere).

How should I use tretinoin gel (microsphere)? Use tretinoin gel (microsphere) exactly as your healthcare provider tells you to use it. Before you apply tretinoin gel (microsphere), gently wash the affected skin area with a mild, non-medicated soap.

Rinse and pat your skin dry. Apply a thin layer of tretinoin gel (microsphere) to the affected area 1 time a day in the evening. Do not use more tretinoin gel (microsphere) than you need to cover the affected area and do not apply tretinoin gel (microsphere) more than 1 time a day.

Using too much tretinoin gel (microsphere) or using it too often will not give you faster or better results, and you may get skin redness, peeling, or discomfort. You may use moisturizers after applying tretinoin gel (microsphere). Early in your treatment, you may get new pimples.

At this stage, it is important to continue using tretinoin gel (microsphere). Your acne may not get better right away. Improvement in your acne may be noticed after 2 weeks of tretinoin gel (microsphere) treatment, but more than 7 weeks of treatment may be needed before you get the full benefit.

Wash your hands after applying tretinoin gel (microsphere). Tretinoin gel (microsphere) taken by mouth in large amounts may lead to the same side effects as those seen with large amounts of Vitamin A taken by mouth. Call the Poison Help line at 1-800-222-1222 if tretinoin gel (microsphere) is taken by mouth.

What should I avoid while using tretinoin gel (microsphere)? You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with tretinoin gel (microsphere). Minimize exposure to sunlight.

If you have to be in the sunlight, are sensitive to sunlight, or are using medicine that cause sensitive to sunlight, use a sunscreen with sun protection factor (SPF) of 15 or more. Wear a wide-brimmed hat or other protective clothing to cover the treated areas, even on days when it is not sunny, or you are inside. Do not use tretinoin gel (microsphere) on sunburn skin until your skin has healed.

What are the possible side effects of tretinoin gel (microsphere)? Tretinoin gel (microsphere) can cause serious side effects, including: Skin irritation.… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 138 words ▾

12.3Pharmacokinetics Absorption Tretinoin is a metabolite of Vitamin A. Percutaneous absorption, as determined by the cumulative excretion of radiolabeled drug into urine and feces, was assessed in 44 healthy males and females after single and repeated daily tretinoin applications up to 28 days of 500 mg of a 0.1% tretinoin gel product. In this assessment, estimates of in vivo bioavailability, mean (SD) were 0.82 (0.11)% and 1.41 (0.54)%, for single and multiple daily topical applications, respectively.

The plasma concentrations of tretinoin and its metabolites, 13- cis -retinoic acid, all- trans -4-oxo-retinoic acid, and 13- cis -4-oxo-retinoic acid, generally ranged from 1 to 3 ng/mL and were essentially unaltered after either single or multiple daily applications of tretinoin gel, 0.1%, relative to baseline levels. Clinical pharmacokinetic studies have not been performed with tretinoin gel, 0.08%, 0.06% and 0.04%.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Clinical Studies of Tretinoin Gel, 0.1% The efficacy of tretinoin gel, 0.1 was evaluated in two double-blind, randomized, vehicle-controlled trials in adult and pediatric subjects 11 years of age and older with acne vulgaris (Studies 1 and 2). Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] . Tretinoin gel, 0.1%, applied topically once daily in the evening, was superior to vehicle gel, applied topically once daily, in reducing the acne lesion counts.

The mean reduction in lesion counts from baseline after treatment for 12 weeks are shown in Table 1: Table 1: Mean Percent Reduction in Lesion Counts in Subjects with Acne Vulgaris at Week 12 in Studies 1 and 2 Study 1 Study 2 Tretinoin Gel 0.1% (n=72) Vehicle Gel (n=71) Tretinoin Gel 0.1% (n=72) Vehicle Gel (n=67) Non-inflammatory lesion counts 49% 22% 32% 3% Inflammatory lesion counts 37% 18% 29% 24% Total lesion counts 45% 23% 32% 16% Efficacy was also assessed by the investigator’s global evaluation, which included categories of “excellent”, “good”, “fair”, “no change”, and “poor”.

Tretinoin gel, 0.1%, was significantly superior (p<0.001) to the vehicle in the investigator's global evaluation of the clinical response: In Study #1, 35% of tretinoin gel, 0.1% -treated subjects achieved an “excellent” result, as compared to 11% of vehicle-treated subjects. In Study #2, 28% of tretinoin gel, 0.1%-treated subjects achieved an “excellent” result, as compared to 9% of vehicle-treated subjects.

14.2Clinical Studies with Tretinoin Gel, 0.04% In two vehicle-controlled clinical trials in adult and pediatric subjects 11 years of age and older with acne vulgaris (Studies 3 and 4). Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] . Tretinoin gel, 0.04%, applied topically once daily in the evening, was more effective (p<0.05) than vehicle gel, applied topically once daily, in reducing the acne lesion counts.

The mean reduction in lesion counts from baseline after treatment for 12 weeks are shown in Table 2: Table 2: Mean Percent Reduction in Lesion Counts in Subjects with Acne Vulgaris at Week 12 in Studies 3 and 4 Study 3 Study 4 Tretinoin Gel 0.04% (n=108) Vehicle Gel (n=111) Tretinoin Gel 0.04% (n=110) Vehicle Gel (n=103) Non-inflammatory lesion counts 37% -2% 29%* 14% Inflammatory lesion counts 44% 13% 41% 30% Total lesion counts 40% 8% 35% 20% * -2% represents a mean percent increase of 2% Efficacy was also assessed by the investigator’s global evaluation, which included categories of “excellent”, “good”, “fair”, “no change”, and “poor”.

Tretinoin gel, 0.04% was superior (p<0.05) to the vehicle in the investigator's global evaluation of the clinical response: In Study #3, 14% of tretinoin gel, 0.04%-treated subjects achieved an “excellent” result, as compared to 5% of vehicle-treated subjects. In Study #4, 19% of tretinoin gel, 0.04%-treated subjects achieved an “excellent” result, as compared to 9% of vehicle-treated subjects.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dermal carcinogenicity testing has not been performed with tretinoin gel, 0.04%, 0.06%, 0.08%, or 0.1%. In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of the 0.04% and 0.1% clinical formulations.

A dose-dependent incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1 mg/kg/day tretinoin, respectively. These doses are two and four times the MRHD based on BSA comparison.

The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the MRHD based on BSA comparison). Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator.

This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources [see Warnings and Precautions (5.3) ] . The genotoxic potential of tretinoin was evaluated in the Ames assay and an in vivo mouse micronucleus assay.

Both tests were negative. The components of the microspheres have shown potential for genetic toxicity and fetal malformation. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in an in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, and an in vivo mouse micronucleus assay.

In fertility studies in rats with oral tretinoin, the no-observable effect level was 2 mg/kg/day (19 times the MRHD based on BSA comparison).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dermal carcinogenicity testing has not been performed with tretinoin gel, 0.04%, 0.06%, 0.08%, or 0.1%. In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of the 0.04% and 0.1% clinical formulations.

A dose-dependent incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1 mg/kg/day tretinoin, respectively. These doses are two and four times the MRHD based on BSA comparison.

The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the MRHD based on BSA comparison). Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator.

This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources [see Warnings and Precautions (5.3) ] . The genotoxic potential of tretinoin was evaluated in the Ames assay and an in vivo mouse micronucleus assay.

Both tests were negative. The components of the microspheres have shown potential for genetic toxicity and fetal malformation. EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in an in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, and an in vivo mouse micronucleus assay.

In fertility studies in rats with oral tretinoin, the no-observable effect level was 2 mg/kg/day (19 times the MRHD based on BSA comparison).

📄 Package Label / Principal Display Panel 5 words ▾

PRINCIPAL DISPLAY PANEL label carton

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 Tretinoin — the program that covers self-administered drugs. 12 manufacturers.
⚠️ 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 Tretinoin. 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
$5.59M
Claims incl. refills
77.6K
Beneficiaries
59.9K
Spend / beneficiary
$93.38
Spend / claim
$72.01
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 — Not published for this NDC No photo available yet for this listing.
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 ✓ 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 Amneal Pharmaceuticals NY LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals NY 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.
← 69238-2261-03 · Amneal 69238-2348-01 · Amneal →
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.