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Tretinoin .05 g/100g Gel — NDC 68682-0800-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tretinoin .05 g/100g Gel — NDC 68682-800-45 (Billing 68682-0800-45)

by Oceanside Pharmaceuticals · 1 TUBE in 1 PACKAGE / 45 g in 1 TUBE

This is a package of Tretinoin .05 g/100g Gel from Oceanside Pharmaceuticals, marketed since Jul 2007 and currently FDA-listed; retail pharmacies pay about $3.89 per g (NADAC). It is this product's only package size.

NDC 68682-0800-45
🏷️ FDA NDC (as labeled) 68682-800-45 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 68682-800-45 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68682 labeler · 800 product · 45 package
Package marketed since
Jul 26, 2007
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6868280045 6
Medicaid fills, this package
5,488 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68682-800-45
Product NDC 68682-800
11-digit billing NDC 68682080045
NCPDP billing unit GM — per gram (weight)
RxCUI 245723
UNII 5688UTC01R
Application # NDA022070
SPL Set ID febda58b-c9ee-4b95-bee7-dca5f2645f98
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-07-26
Route TOPICAL
Dosage form GEL
Substance TRETINOIN
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90050030004015
GPI class Tretinoin
GCN Seq No 021108
GCN 22872
HICL code 002468
Ingredient (HICL) Tretinoin
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 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TRETINOIN 0.05% GEL
FDB brand name Tretinoin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 021108
  • GCN: 22872
  • GPI-14 (Medi-Span): 90050030004015
  • HICL (First Databank): 002468
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 245723
Why two NDCs? The FDA registers this code as 68682-800-45 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68682-0800-45. 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

Label name TRETINOIN 0.05% GEL Ingredient Tretinoin
📖 What it is MedlinePlus · NLM

Tretinoin is used to treat acne. Tretinoin is also used to reduce fine wrinkles. Tretinoin is in a class of medications called retinoids. It works by increasing production of new skin cells and unclogging pores.

Read the full MedlinePlus article ↗
📗 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 $3.892 $175.15 / 45 g
Medicaid paysCMS SDUD · 12 mo $6.22 $279.94 / 45 g
Medicare drug plans payPart D · Q2 2026 $5.10 $229.49 / 45 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 May 2022 Sep 2022 Feb 2024 $5.155 $3.771
▼ Down 2% over the last 14 months.
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
68682-0800-45 You're viewing this Main listing 1 TUBE in 1 PACKAGE / 45 g in 1 TUBE 2007-07-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tretinoin .05 g/100gthis 68682-0800-45 Oceanside 1 tube $3.892 AB FDA listed —
Tretinoin .5 mg/g 00378-8090-45 Mylan 1 tube $3.933 AB Availability likely +1%
Atralin .05 g/100g 13548-0070-45 Bausch 1 tube — AB FDA listed —
Tretinoin .05 g/100g 62032-0413-20 Obagi 20 g — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Tretinoin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 0QQJ25X58G
    Isobutylparaben is a preservative derived from para-hydroxybenzoic acid. It prevents bacterial and fungal growth in medicines, extending shelf life and maintaining product safety during storage.
  • UNII 8JC99XGU4W
    Soluble fish skin collagen is a protein derived from fish skin that acts as a binder and thickening agent in medicines. It helps hold ingredients together and gives the product the right texture or consistency.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 7JPC6Y25QS
    A synthetic nonionic surfactant, a type of cleaning agent used in pharmaceutical formulations. It functions as an emulsifier and solubilizer, helping mix water and oil-based ingredients and improving how the medicine dissolves and spreads in the body.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety 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

LabelerOceanside Pharmaceuticals
Application holderDOW PHARMACEUTICAL SCIENCES
FDA applicationNDA022070 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedJul 2007
Product typeHuman Prescription Drug
Portfolio87 products on file

More NDCs from Oceanside Pharmaceuticals labeler code 68682

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 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 29 words ▾

1 INDICATIONS AND USAGE Tretinoin Gel is indicated for topical treatment of acne vulgaris. Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )

⏱️ Dosage and Administration 208 words ▾

2 DOSAGE AND ADMINISTRATION For topical use only. Not for oral, ophthalmic, or intravaginal use. Tretinoin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area.

Tretinoin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy. Patients treated with Tretinoin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

When treating with Tretinoin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Tretinoin Gel has begun. • Apply a thin layer of Tretinoin Gel once daily, before bedtime, to skin where lesions occur.

Keep away from eyes, mouth, nasal creases, and mucous membranes. ( 2 ) • Tretinoin Gel is not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 31 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 0.05% Each gram of Tretinoin Gel contains 0.5 mg (0.05%) tretinoin in a translucent to opaque, pale yellow topical gel. Gel, 0.05% ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Tretinoin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 ) • Topical over-the-counter acne preparations, concomitant topical medications, medicated cleansers, topical products with alcohol or astringents: Use with caution, irritation may occur. ( 5.1 ) • Avoid unprotected exposure to sunlight including sunlamps (UV light) when using Tretinoin Gel due to potential for increased photosensitization.

Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) • Avoid use of Tretinoin Gel with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) • Use Tretinoin Gel with caution if allergic to fish due to potential for allergenicity to fish protein.

Patients who develop pruritus or urticaria should contact their healthcare provider. ( 5.3 )

5.1Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Tretinoin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful. Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions.

To help limit skin irritation, patients must: • wash the treated skin gently, using a mild, non-medicated soap, and pat it dry, • avoid washing the treated skin too often and scrubbing the affected skin area, and • avoid contact with the peels of limes.

5.2Ultraviolet Light and Environmental Exposure Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Tretinoin Gel. 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 of at least SPF 15 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 tretinoin-treated skin.

5.3Fish Allergies Tretinoin Gel contains soluble fish proteins and should be used with caution in patients with known sensitivity or allergy to fish. Patients who develop pruritus or urticaria should contact their healthcare provider.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥5%) with Tretinoin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under prescribing 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. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies (14) ]. In these studies, 50% of the subjects who were treated with Tretinoin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions.

In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below).

Most skin-related adverse reactions first appear during the first two weeks of treatment with Tretinoin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects, the skin-related adverse reactions persist throughout the treatment period. Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in at Least 1% of Subjects) Event Tretinoin Gel (N = 674) Vehicle (N = 487) Dry Skin 109 (16%) 8 (2%) Peeling/Scaling/Flaking Skin 78 (12%) 7 (1%) Skin Burning Sensation 53 (8%) 8 (2%) Erythema 47 (7%) 1 (<1%) Pruritus 11 (2%) 3 (1%) Pain of Skin 7 (1%) 0 (0%) Sunburn 7 (1%) 3 (1%)

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Tretinoin Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy There are no well-controlled trials in pregnant women treated with Tretinoin Gel. Tretinoin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tretinoin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application.

The dose of 1 g/kg/day was approximately four times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Tretinoin Gel-treated animals. These findings were not observed in control animals.

Other maternal and reproductive parameters in the Tretinoin Gel-treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Tretinoin Gel applied daily to a 50 kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates.

Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately eight times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported.

Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately eight times the clinical dose assuming 100% absorption and based on body surface area comparison).

Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.

Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic Effects on Fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses eight times the clinical dose based on body surface area comparison.

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tretinoin Gel is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years) treated with Tretinoin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.

8.5Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Tretinoin Gel did not include any subjects over age 65 to determine whether they respond differently… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy There are no well-controlled trials in pregnant women treated with Tretinoin Gel. Tretinoin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Tretinoin Gel at doses of 0.1, 0.3 and 1 g/kg/day was tested for maternal and developmental toxicity in pregnant Sprague-Dawley rats by dermal application.

The dose of 1 g/kg/day was approximately four times the clinical dose assuming 100% absorption and based on body surface area comparison. Possible tretinoin-associated teratogenic effects (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were noted in the fetuses of Tretinoin Gel-treated animals. These findings were not observed in control animals.

Other maternal and reproductive parameters in the Tretinoin Gel-treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the clinical dose is defined as 2 g of Tretinoin Gel applied daily to a 50 kg person. Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters and nonhuman primates.

Tretinoin was teratogenic in Wistar rats when given orally in doses greater than 1 mg/kg/day (approximately eight times the clinical dose based on body surface area comparison). In the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day, but none were observed at 5 mg/kg/day (approximately 80 times the clinical dose based on body surface area comparison), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported.

Similar results have also been reported in pigtail macaques. Topical tretinoin in a different formulation has generated equivocal results in animal teratogenicity tests. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (approximately eight times the clinical dose assuming 100% absorption and based on body surface area comparison).

Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 160 times the clinical dose assuming 100% absorption and based on body surface area comparison) was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids. With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone.

Cases of temporally associated congenital malformations have been reported with use of other topical tretinoin products. The significance of these spontaneous reports in terms of risk to the fetus is not known. Nonteratogenic Effects on Fetuses: Oral tretinoin has been shown to be fetotoxic in rats when administered in doses 20 times the clinical dose based on body surface area comparison.

Topical tretinoin has been shown to be fetotoxic in rabbits when administered in doses eight times the clinical dose based on body surface area comparison.

🧒 Pediatric Use 54 words ▾

8.4Pediatric Use Safety and effectiveness in children below the age of 10 have not been established. A total of 381 pediatric subjects (aged 10 to 16 years) treated with Tretinoin Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.

🧓 Geriatric Use 36 words ▾

8.5Geriatric Use Safety and effectiveness in a geriatric population have not been established. Clinical studies of Tretinoin Gel did not include any subjects over age 65 to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product. Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which 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, other mechanisms, or both.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.3Pharmacokinetics In two studies, the plasma levels of tretinoin and its major metabolites (13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid) were investigated in a total of 14 patients (age: 13 – 25 years) with severe acne, who applied 4 g ± 0.5 g (range 3.5 g – 4.5 g) of Tretinoin Gel once daily to face, back and chest, as compared to a mean of 0.71 g (range of 0.07 – 3.71 g) applied in the controlled clinical trials. Blood samples were taken at baseline and immediately prior to treatment on Days 1, 5, 10 and 14.

On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-treatment. The plasma concentrations of tretinoin and its metabolites could be measured (LOQ = 0.5 ng/mL for all three analytes) in all patients at all time points. The range of plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid and all-trans-4-oxo-retinoic acid at baseline and after multiple once-daily applications of Tretinoin Gel, 0.05% for 14 days are given in Table 2 (below).

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients. Table 2: Concentrations of Active and Metabolites at Baseline and at Day 14 After Exposure to Tretinoin Gel, 0.05% Compound Baseline Concentration Range (ng/mL) Day 14 Concentration Range (ng/mL) Tretinoin 0.68-1.62 0.69-2.88 13-cis-retinoic acid 0.67-1.79 0.51-2.26 4-oxo-13-cis-retinoic acid 0.82-5.92 0.59-6.96

🧬 Mechanism of Action 144 words ▾

12.1Mechanism of Action Tretinoin is a metabolite of Vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product. Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which 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, other mechanisms, or both.

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

📦 How Supplied / Storage and Handling 59 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tretinoin Gel, 0.05% is a translucent to opaque, pale yellow topical gel and available as: • NDC 68682-800-45 45 g tube Storage and Handling: Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from freezing. Keep out of reach of children.

📦 Storage and Handling 33 words ▾

Storage and Handling: Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Protect from freezing. Keep out of reach of children.

📋 Description 130 words ▾

11 DESCRIPTION Tretinoin Gel, 0.05% is a translucent to opaque, pale yellow gel containing 0.05% tretinoin, by weight for topical administration. Chemically, tretinoin 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. It is a member of the retinoid class of compounds, and a metabolite of Vitamin A.

Tretinoin has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following structure: Each gram of Tretinoin Gel, 0.05% contains 0.5 mg of tretinoin. Other components of this formulation are benzyl alcohol, butylparaben, butylated hydroxytoluene, carbomer homopolymer Type C, ethylparaben, fish collagen hydrolyzates, glycerin, isobutylparaben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine. The contribution to efficacy of individual components of the vehicle has not been evaluated. chem.jpg

💬 Information for Patients 192 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel. Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating.

Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel. Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable.

Caution patients against application of Tretinoin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation. Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.

Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada All other product/brand names and/or logos are trademarks of the respective owners. © 2024 Bausch Health Companies Inc. or its affiliates 9571701

🍼 Nursing Mothers 36 words ▾

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tretinoin Gel is administered to a nursing woman.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics In two studies, the plasma levels of tretinoin and its major metabolites (13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid) were investigated in a total of 14 patients (age: 13 – 25 years) with severe acne, who applied 4 g ± 0.5 g (range 3.5 g – 4.5 g) of Tretinoin Gel once daily to face, back and chest, as compared to a mean of 0.71 g (range of 0.07 – 3.71 g) applied in the controlled clinical trials. Blood samples were taken at baseline and immediately prior to treatment on Days 1, 5, 10 and 14.

On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours post-treatment. The plasma concentrations of tretinoin and its metabolites could be measured (LOQ = 0.5 ng/mL for all three analytes) in all patients at all time points. The range of plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid and all-trans-4-oxo-retinoic acid at baseline and after multiple once-daily applications of Tretinoin Gel, 0.05% for 14 days are given in Table 2 (below).

Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients. Table 2: Concentrations of Active and Metabolites at Baseline and at Day 14 After Exposure to Tretinoin Gel, 0.05% Compound Baseline Concentration Range (ng/mL) Day 14 Concentration Range (ng/mL) Tretinoin 0.68-1.62 0.69-2.88 13-cis-retinoic acid 0.67-1.79 0.51-2.26 4-oxo-13-cis-retinoic acid 0.82-5.92 0.59-6.96

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of Tretinoin Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two 12-week prospective, multicenter, randomized, controlled trials. Subjects in these two trials ranged from 10 to 65 years of age, were approximately 52% female, 48% male, and were 74% Caucasian, 15% Black or African American, 3% Asian, and 8% Other. Efficacy results at Week 12 are presented in Table 3.

Success on the 6-point Global Severity Score is defined as a score of 0 (clear) or 1 (very mild). In Trial 2, subjects were also required to have at least two grades reduction from baseline for success. ‘Very mild’ acne is defined as: skin almost clear; rare non-inflammatory lesions present, with rare non-inflamed papules (papules may be hyperpigmented, though not pink-red, less than 4 lesions). The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

Table 3: Efficacy Results at Week 12 in Trials 1 and 2 Trial 1 Tretinoin Gel (N=375) Vehicle (N=185) Global Severity Score Success Success was defined as 0 (clear) or 1 (very mild) 78 (21%) 23 (12%) Non-Inflammatory Facial Lesions Mean Baseline Count 50.7

52.4Mean Absolute Reduction 21.8

10.3Mean Percent Reduction 43% 21% Inflammatory Facial Lesions Mean Baseline Count 23.4

23.9Mean Absolute Reduction 9.7

5.8Mean Percent Reduction 41% 26% Total Facial Lesions Mean Baseline Count 74.1

76.3Mean Absolute Reduction 31.4

16.1Mean Percent Reduction 43% 22% Trial 2 Tretinoin Gel (N=299) Vehicle (N=302) Global Severity Score Success Success was defined as 0 (clear) or 1 (very mild) with at least two grades reduction from baseline 69 (23%) 42 (14%) Non-Inflammatory Facial Lesions Mean Baseline Count 51.9

52.7Mean Absolute Reduction 18.7

10.8Mean Percent Reduction 37% 20% Inflammatory Facial Lesions Mean Baseline Count 22.9

23.4Mean Absolute Reduction 7.0

4.0Mean Percent Reduction 30% 17% Total Facial Lesions Mean Baseline Count 74.8

76.1Mean Absolute Reduction 25.7

14.7 Mean Percent Reduction 35% 19%

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0.005%, 0.025% and 0.05% Tretinoin Gel. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results. Studies in hairless albino mice with a different formulation 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 was 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. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (3 mg/m 2 , approximately four times the clinical dose based on body surface area comparison), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day and above (1.5 mg/m 2 , approximately two times the clinical dose based on body surface area comparison) were observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year dermal mouse carcinogenicity study was initiated with topical administration of 0.005%, 0.025% and 0.05% Tretinoin Gel. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results. Studies in hairless albino mice with a different formulation 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 was 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. The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay.

All tests were negative. In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (3 mg/m 2 , approximately four times the clinical dose based on body surface area comparison), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day and above (1.5 mg/m 2 , approximately two times the clinical dose based on body surface area comparison) were observed.

📄 Patient Package Insert ~3 min read ▾

Patient Information Tretinoin Gel, 0.05% for topical use Important information: Tretinoin Gel is for use on skin only. Do not get Tretinoin Gel in your mouth, eyes, vagina, or the corners of your nose. What is Tretinoin Gel?

Tretinoin Gel is a prescription medicine used on the skin (topical) to treat acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if Tretinoin Gel is safe and effective in children under 10 years of age.

What should I tell my healthcare provider before using Tretinoin Gel? Before using Tretinoin Gel, tell your healthcare provider about all of your medical conditions, including if you: • are allergic to fish. Tretinoin Gel contains fish proteins.

Tell your healthcare provider if you get hives or itching during treatment with Tretinoin Gel. • have a skin condition called eczema. • have a sunburn. • are pregnant or plan to become pregnant. It is not known if Tretinoin Gel will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Tretinoin Gel passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and any skin products that you use. Especially tell your healthcare provider if you use any other medicines to treat your acne, including medicated cleansers or soaps. Using other topical acne products may increase the irritation of your skin when used with Tretinoin Gel.

How should I use Tretinoin Gel? • Use Tretinoin Gel exactly as your healthcare provider tells you to use it. • Before you apply Tretinoin Gel, gently wash the affected skin area with a mild, non-medicated soap. Rinse and pat your skin dry. • Apply Tretinoin Gel 1 time a day before bedtime. • Apply a thin layer of Tretinoin Gel to cover the affected skin areas. Gently rub Tretinoin Gel into your skin. • Do not use more Tretinoin Gel than you need to cover the affected area and do not apply Tretinoin Gel more than 1 time a day.

Using too much Tretinoin Gel may irritate or increase the irritation of your skin, and will not give faster or better results. • You may use moisturizers and cosmetics. What should I avoid while using Tretinoin Gel? • Avoid washing your skin too often and scrubbing the affected skin area. • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with Tretinoin Gel. • Minimize exposure to sunlight. • If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with a sun protection factor (SPF) of 15 or more and wear protective clothing, and a wide brimmed hat to cover the treated areas. • If you do get sunburned, stop using Tretinoin Gel until your skin has healed and is back to normal. • Cold weather and wind may irritate skin treated with Tretinoin Gel.

Skin treated with Tretinoin Gel may dry out or get wind burned more easily. Talk to your healthcare provider about ways to manage skin irritation. • Avoid contact with the peels of limes. What are the possible side effects of Tretinoin Gel?

Tretinoin Gel may cause skin irritation, including: skin dryness, burning, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to stop using Tretinoin Gel for a while, decrease the number of times you apply Tretinoin Gel, or completely stop treatment with Tretinoin Gel. It is not known if Tretinoin Gel is effective when used less than 1 time a day.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the side effects possible with Tretinoin Gel. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. How should I store Tretinoin Gel? • Store Tretinoin Gel at room temperature, 68°F to 77°F (20°C to 25°C). • Protect from freezing. Keep Tretinoin Gel and all medicines out of the reach of children.

General information ab… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 26 words ▾

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 68682-800-45 Rx only TRETINOIN GEL 0.05% FOR TOPICAL USE ONLY Net Wt. 45 g OCEANSIDE PHARMACEUTICALS carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.5K
Units reimbursed last 4 qtrs
248.5K
Gross reimbursed last 4 qtrs
$1.55M
Avg / prescription
$281.70
Avg / unit
$6.2208
Latest quarter Q4 2025
0Rx
Medicaid pays / g
$6.2208
gross reimbursed
vs
NADAC / g
$3.8923
acquisition cost
=
Spread
+$2.3285
+60% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
82% FFS 18% MCO
Fee-for-service · 4,512 Rx Managed care · 976 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,475 units · 177 per 100k residents ME Washington: 5,850 units · 74.9 per 100k residents WA Idaho: 1,440 units · 73.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 178,525 units · 912 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 1,215 units · 132 per 100k residents SD Iowa: 1,080 units · 33.7 per 100k residents IA Illinois: 8,055 units · 64.2 per 100k residents IL Indiana: no data reported IN Ohio: 6,455 units · 54.8 per 100k residents OH Pennsylvania: 1,035 units · 8.0 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 540 units · 7.7 per 100k residents MA California: 17,910 units · 46.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 4,680 units · 53.7 per 100k residents VA Maryland: 3,015 units · 48.8 per 100k residents MD Connecticut: 2,610 units · 72.2 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 2,340 units · 79.6 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 2,340 units · 21.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,460 units · 27.7 per 100k residents TX Florida: 495 units · 2.2 per 100k residents FL
Units reimbursed · per 100k residents
2.2912
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 912 /100k
2 Maine 177 /100k
3 South Dakota 132 /100k
4 Kansas 79.6 /100k
5 Washington 74.9 /100k
6 Idaho 73.3 /100k
7 Connecticut 72.2 /100k
8 Illinois 64.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
← 68682-0713-01 · OCEANSIDE 68682-0850-60 · Oceanside →
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.