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Targretin bexarotene 1 g/100g Gel — NDC 00187-5525-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Targretin bexarotene 1 g/100g Gel — NDC 0187-5525-60 (Billing 00187-5525-60)

by Bausch Health US, LLC · 1 TUBE in 1 CARTON / 60 g in 1 TUBE

This is a package of Targretin bexarotene 1 g/100g Gel from Bausch Health US, LLC, marketed since Jun 2000 and currently FDA-listed. It is this product's only package size.

NDC 00187-5525-60
🏷️ FDA NDC (as labeled) 0187-5525-60 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0187-5525-60
Product NDC 0187-5525
11-digit billing NDC 00187552560
NCPDP billing unit GM — per gram (weight)
RxCUI 308724, 991233
UNII A61RXM4375
Application # NDA021056
SPL Set ID d35b4697-3f3b-4aa1-b5d9-153993e83811
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-06-28
Route TOPICAL
Dosage form GEL
Substance BEXAROTENE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 90376220004020
GPI class Targretin
GCN Seq No 045771
GCN 89921
HICL code 020832
Ingredient (HICL) Bexarotene
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5N
Therapeutic class — specific (HIC3) Topical Antineoplastic Premalignant Lesion Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TARGRETIN 1% GEL
FDB brand name Targretin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 045771
  • GCN: 89921
  • GPI-14 (Medi-Span): 90376220004020
  • HICL (First Databank): 020832
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 308724
Why two NDCs? The FDA registers this code as 0187-5525-60 — a 4-4-2 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 labeler segment → 00187-5525-60. 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 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 TARGRETIN 1% GEL Ingredient Bexarotene
📗 Our plain-language guide HelloPharmacist
  • It treats skin lesions from early-stage cutaneous T-cell lymphoma, or CTCL. It's used when other treatments haven't worked well or weren't tolerated.
  • You'll start every other day and slowly work up as your skin tolerates it. Cover each lesion with a generous coat, let it dry, and keep it off healthy skin and mucous areas. Don't...
  • Skin reactions are most common: rash, itching, and pain where you apply it. If irritation is severe, call your doctor. They may have you apply it less often or pause for a few days...
  • No. It may harm an unborn baby. You need a negative pregnancy test before starting and monthly after, plus effective contraception. Men with partners who could be pregnant need to...
📖 Read our full Bexarotene Topical guide →
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 $498.42 $29,904.91 / 60 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
00187-5525-60 You're viewing this Main listing 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2000-06-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Targretin 1 g/100gthis 00187-5525-60 Bausch 1 tube — AB FDA listed —
Bexarotene 10 mg/g 69238-2088-06 Amneal 1 tube — AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2000
On the market since
Jun 2000
📍
2026
Currently FDA-listed
26 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.

4 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

LabelerBausch Health US, LLC
Application holderBAUSCH HEALTH IRELAND LTD
FDA applicationNDA021056 (NDA)
Labeler code00187
First marketedJun 2000
Product typeHuman Prescription Drug
Portfolio51 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 40 words ▾

INDICATIONS AND USAGE Targretin (bexarotene) gel 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Targretin gel should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day.

Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside.

See CONTRAINDICATIONS, Pregnancy. Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry before covering with clothing.

Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel near mucosal surfaces of the body. A response may be seen as soon as four weeks after initiation of therapy but most patients require longer application.

With continued application, further benefit may be attained. The longest onset time for the first response among the responders was 392 days based on the Composite Assessment of Index Lesion Severity in the multicenter study. In clinical trials, Targretin gel was applied for up to 172 weeks.

Targretin gel should be continued as long as the patient is deriving benefit. Occlusive dressings should not be used with Targretin gel. Targretin gel is a topical therapy and is not intended for systemic use.

Targretin gel has not been studied in combination with other CTCL therapies.

⛔ Contraindications ~2 min read ▾

CONTRAINDICATIONS Targretin gel 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product. Pregnancy Targretin gel 1% may cause fetal harm when administered to a pregnant woman. Targretin gel must not be given to a pregnant woman or a woman who intends to become pregnant.

If a woman becomes pregnant while taking Targretin gel, Targretin gel must be stopped immediately and the woman given appropriate counseling. Bexarotene caused malformations when administered orally to pregnant rats during days 7-17 of gestation. Developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day.

At doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. The no-effect oral dose in rats was 1 mg/kg/day. Plasma bexarotene concentrations in patients with CTCL applying Targretin gel 1% were generally less than one hundredth the C max associated with dysmorphogenesis in rats, although some patients had Cmax levels that were approximately one eighth the concentration associated with dysmorphogenesis in rats.

Women of child-bearing potential should be advised to avoid becoming pregnant when Targretin gel is used. The possibility that a woman of child-bearing potential is pregnant at the time therapy is instituted should be considered. A negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-HCG) with a sensitivity of at least 50 mIU/L should be obtained within one week prior to Targretin gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on Targretin gel.

Effective contraception must be used for one month prior to the initiation of therapy, during therapy and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while applying Targretin gel and for at least one month after the last dose of drug. Targretin gel therapy should be initiated on the second or third day of a normal menstrual period.

No more than a one month supply of Targretin gel should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The safety of Targretin gel has been assessed in clinical studies of 117 patients with CTCL who received Targretin gel for up to 172 weeks. In the multicenter open-label study, 50 patients with CTCL received Targretin gel for up to 98 weeks. The mean duration of therapy for these 50 patients was 199 days.

The most common adverse events reported with an incidence at the application site of at least 10% in patients with CTCL were rash, pruritus, skin disorder, and pain. Adverse events leading to dose reduction or study drug discontinuation in at least two patients were rash, contact dermatitis, and pruritus. Of the 49 patients (98%) who experienced any adverse event, most experienced events categorized as mild (9 patients, 18%) or moderate (27 patients, 54%).

There were 12 patients (24%) who experienced at least one moderately severe adverse event. The most common moderately severe events were rash (7 patients, 14%) and pruritus (3 patients, 6%). Only one patient (2%) experienced a severe adverse event (rash).

In the patients with CTCL receiving Targretin gel, adverse events reported regardless of relationship to study drug at an incidence of ≥5% are presented in Table 1. A similar safety profile for Targretin gel was demonstrated in the Phase I-II program. For the 67 patients enrolled in the Phase I-II program, the mean duration of treatment was 436 days (range 12-1203 days).

As in the multicenter study, the most common adverse events regardless of relationship to study drug in the Phase I-II program were rash (78%), pain (40%), and pruritus (40%). Table 1. Incidence of All Adverse Events* and Application Site Adverse Events with Incidence ≥5% for All Application Frequencies of Targretin Gel in the Multicenter CTCL Study * Regardless of association with treatment Includes Investigator terms such as: 1 Contact dermatitis, irritant contact dermatitis, irritant dermatitis 2 Pruritus, itching, itching of lesion 3 Erythema, scaling, irritation, redness, rash, dermatitis 4 Skin inflammation, excoriation, sticky or tacky sensation of skin; NOS = Not Otherwise Specified To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

All Adverse Events Application Site Adverse Events COSTART 5 Body System/Preferred Term N = 50 n (%) N = 50 n (%) Skin and Appendages Contact Dermatitis 1 7 (14) 4 (8) Exfoliative Dermatitis 3 (6) 0 Pruritus 2 18 (36) 9 (18) Rash 3 36 (72) 28 (56) Maculopapular Rash 3 (6) 0 Skin Disorder (NOS) 4 13 (26) 9 (18) Sweating 3 (6) 0 Body as a Whole Asthenia 3 (6) 0 Headache 7 (14) 0 Infection 9 (18) 0 Pain 15 (30) 9 (18) Cardiovascular Edema 5 (10) 0 Peripheral Edema 3 (6) 0 Hemic and Lymphatic Leukopenia 3 (6) 0 Lymphadenopathy 3 (6) 0 WBC Abnormal 3 (6) 0 Metabolic and Nutritional Hyperlipemia 5 (10) 0 Nervous Paresthesia 3 (6) 3 (6) Respiratory Cough Increased 3 (6) 0 Pharyngitis 3 (6) 0

🔄 Drug Interactions 163 words ▾

Drug-Drug Interactions Patients who are applying Targretin gel should not concurrently use products that contain DEET ( N,N -diethyl- m -toluamide), a common component of insect repellent products. An animal toxicology study showed increased DEET toxicity when DEET was included as part of the formulation. No formal studies to evaluate drug interactions with bexarotene have been conducted.

Bexarotene oxidative metabolites appear to be formed through cytochrome P450 3A4. On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations. Similarly, based on data that gemfibrozil increases bexarotene concentrations following oral bexarotene administration, concomitant gemfibrozil could increase bexarotene plasma concentrations.

However, due to the low systemic exposure to bexarotene after low to moderately intense gel regimens (see CLINICAL PHARMACOLOGY ), increases that occur are unlikely to be of sufficient magnitude to result in adverse effects. No drug interaction data are available on concomitant administration of Targretin gel and other CTCL therapies.

🤰 Pregnancy 5 words ▾

Pregnancy : See CONTRAINDICATIONS .

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 77 words ▾

Geriatric Use Of the total patients with CTCL in clinical studies of Targretin gel, 62% were under 65 years and 38% were 65 years or older. No overall differences in safety were observed between patients 65 years of age or older and younger patients, but greater sensitivity of some older individuals to Targretin gel cannot be ruled out. Responses to Targretin gel were observed across all age group decades, without preference for any individual age group decade.

🆘 Overdosage 65 words ▾

OVERDOSAGE Systemic toxicity following acute overdosage with topical application of Targretin gel is unlikely because of low systemic plasma levels observed with normal therapeutic doses. There is no specific antidote for overdosage. There has been no experience with acute overdose of Targretin gel in humans. Any overdose with Targretin gel should be treated with supportive care for the signs and symptoms exhibited by the patient.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Bexarotene selectively binds and activates retinoid X receptor subtypes (RXRα, RXRβ, RXRγ). RXRs can form heterodimers with various receptor partners such as retinoic acid receptors (RARs), vitamin D receptor, thyroid receptor, and peroxisome proliferator activator receptors (PPARs). Once activated, these receptors function as transcription factors that regulate the expression of genes that control cellular differentiation and proliferation.

Bexarotene inhibits the growth in vitro of some tumor cell lines of hematopoietic and squamous cell origin. It also induces tumor regression in vivo in some animal models. The exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.

Pharmacokinetics General Plasma concentrations of bexarotene were determined during clinical studies in patients with CTCL or following repeated single or multiple-daily dose applications of Targretin gel 1% for up to 132 weeks. Plasma bexarotene concentrations were generally less than 5 ng/mL and did not exceed 55 ng/mL. However, only two patients with very intense dosing regimens (> 40% BSA lesions and QID dosing) were sampled.

Plasma bexarotene concentrations and the frequency of detecting quantifiable plasma bexarotene concentrations increased with increasing percent body surface area treated and increasing quantity of Targretin gel applied. The sporadically observed and generally low plasma bexarotene concentrations indicated that, in patients receiving doses of low to moderate intensity, there is a low potential for significant plasma concentrations following repeated application of Targretin gel. Bexarotene is highly bound (>99%) to plasma proteins.

The plasma proteins to which bexarotene binds have not been elucidated, and the ability of bexarotene to displace drugs bound to plasma proteins and the ability of drugs to displace bexarotene binding have not been studied (see PRECAUTIONS, Protein Binding ). The uptake of bexarotene by organs or tissues has not been evaluated. Metabolism Four bexarotene metabolites have been identified in plasma following oral administration of bexarotene: 6- and 7-hydroxy-bexarotene and 6- and 7-oxo-bexarotene.

In vitro studies suggest that cytochrome P450 3A4 is the major cytochrome P450 responsible for formation of the oxidative metabolites and that the oxidative metabolites may be glucuronidated. The oxidative metabolites are active in in vitro assays of retinoid receptor activation, but the relative contribution of the parent and any metabolites to the efficacy and safety of Targretin gel is unknown. Elimination The renal elimination of bexarotene and its metabolites was examined in patients with Type 2 diabetes mellitus following oral administration of bexarotene.

Neither bexarotene nor its metabolites were excreted in urine in appreciable amounts. Special Populations Elderly, Gender, Race: Because of a large number of immeasurable plasma concentrations (< 1ng/mL), any potential pharmacokinetic differences between Special Populations could not be assessed. Pediatric: Studies to evaluate bexarotene pharmacokinetics in the pediatric population have not been conducted (see PRECAUTIONS, Pediatric Use ).

Renal Insufficiency: No formal studies have been conducted with Targretin gel in patients with renal insufficiency. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of an orally administered dose), but because renal insufficiency can result in significant protein binding changes, pharmacokinetics may be altered in patients with renal insufficiency (see PRECAUTIONS, Renal Insufficiency ). Hepatic Insufficiency: No specific studies have been conducted with Targretin gel in patients with hepatic insufficiency.

Because less than 1% of the dose of oral bexarotene is excreted in the urine unchanged and there is in vitro evidence of extensive hepatic contribution to bexarotene elimination, hepatic… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 96 words ▾

HOW SUPPLIED Targretin gel is supplied in tubes containing 60 g (600 mg active bexarotene). 60 g tube………………………………………NDC 0187-5525-60 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid exposing to high temperatures and humidity after the tube is opened.

Protect from light. Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 USA Targretin is a trademark of Bausch Health Companies Inc. or its affiliates. © 2020 Bausch Health Companies Inc. or its affiliates Rev.

02/2020 9553902

📋 Description 128 words ▾

DESCRIPTION Targretin ® (bexarotene) gel 1% contains bexarotene and is intended for topical application only. Bexarotene is a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs).

The chemical name is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)ethenyl] benzoic acid, and the structural formula is as follows: Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C 24 H 28 O 2 . It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Targretin gel is a clear gelled solution containing 1.0% (w/w) bexarotene in a base of dehydrated alcohol, USP, polyethylene glycol 400, NF, hydroxypropyl cellulose, NF, and butylated hydroxytoluene, NF. targretin-gel-01

💬 Information for Patients 12 words ▾

Information for Patients Please see accompanying “ Patient’s Instructions for Use ”.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Pregnancy : See CONTRAINDICATIONS . General: Targretin gel should be used with caution in patients with a known hypersensitivity to other retinoids. No clinical instances of cross-reactivity have been noted.

Vitamin A Supplementation: In clinical studies, patients were advised to limit vitamin A intake to ≤15,000 IU/day. Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to avoid potential additive toxic effects. Photosensitivity: Retinoids as a class have been associated with photosensitivity.

In vitro assays indicate that bexarotene is a potential photosensitizing agent. There were no reports of photosensitivity in patients in the clinical studies. Patients should be advised to minimize exposure to sunlight and artificial ultraviolet light during the use of Targretin gel.

Information for Patients Please see accompanying “ Patient’s Instructions for Use ”. Drug-Drug Interactions Patients who are applying Targretin gel should not concurrently use products that contain DEET ( N,N -diethyl- m -toluamide), a common component of insect repellent products. An animal toxicology study showed increased DEET toxicity when DEET was included as part of the formulation.

No formal studies to evaluate drug interactions with bexarotene have been conducted. Bexarotene oxidative metabolites appear to be formed through cytochrome P450 3A4. On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations.

Similarly, based on data that gemfibrozil increases bexarotene concentrations following oral bexarotene administration, concomitant gemfibrozil could increase bexarotene plasma concentrations. However, due to the low systemic exposure to bexarotene after low to moderately intense gel regimens (see CLINICAL PHARMACOLOGY ), increases that occur are unlikely to be of sufficient magnitude to result in adverse effects. No drug interaction data are available on concomitant administration of Targretin gel and other CTCL therapies.

Renal Insufficiency No formal studies have been conducted with Targretin gel in patients with renal insufficiency. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway for bexarotene (<1% of an orally administered dose), but because renal insufficiency can result in significant protein binding changes, and bexarotene is >99% protein bound, pharmacokinetics may be altered in patients with renal insufficiency. Hepatic Insufficiency No specific studies have been conducted with Targretin gel in patients with hepatic insufficiency.

Because less than 1% of the dose of oral bexarotene is excreted in the urine unchanged and there is in vitro evidence of extensive hepatic contribution to bexarotene elimination, hepatic impairment would be expected to lead to greatly decreased clearance. Protein Binding Bexarotene is highly bound (>99%) to plasma proteins. The plasma proteins to which bexarotene binds have not been elucidated, and the ability of bexarotene to displace drugs bound to plasma proteins and the ability of drugs to displace bexarotene binding have not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene was not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic in vivo (micronucleus test in mice).

No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days. Use in Nursing Mothers It is not known whether bexarotene is excreted in human milk.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bexarotene, a decision should be mad… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 62 words ▾

Use in Nursing Mothers It is not known whether bexarotene is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bexarotene, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 69 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene was not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic in vivo (micronucleus test in mice).

No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days.

📖 Instructions for Use ~3 min read ▾

Patient’s Instructions for Use Targretin ® (bexarotene) 1% gel (For Topical Use Only) To help you get the full benefits from this medicine, you should read this leaflet carefully and ask your doctor to explain anything you do not understand. What are the most important things I should know about Targretin ® gel? Do not use Targretin gel if you are pregnant or if you plan to become pregnant. • Targretin gel may harm your fetus (unborn baby).

You should contact your doctor immediately if you believe or suspect you are pregnant while you are using Targretin gel and until one month after you stop using Targretin gel. • If you are capable of becoming pregnant, you must have a pregnancy test, within one week before you start Targretin gel therapy and monthly while you are using Targretin gel, confirming you are not pregnant. • You must use effective contraception (birth control) continuously starting one month before beginning treatment with Targretin gel until one month after you stop using Targretin gel.

It is recommended that two reliable forms of contraception be used together. • If you are male and your partner is pregnant or capable of becoming pregnant, you should discuss with your doctor the precautions you should take. What is Targretin gel? Targretin (tar-GRET-in) gel contains bexarotene (beks-AIR-oh-teen).

Targretin gel belongs to a class of medicines known as retinoids. What are the uses for Targretin gel? This medicine is used to treat the skin problems arising from a disease called cutaneous T-cell lymphoma, or CTCL.

Your health care provider has prescribed Targretin for the topical treatment of the cutaneous T-cell lymphoma (CTCL), or mycosis fungoides (MF), lesions (sometimes referred to as patches or plaques) on your skin. Your doctor must instruct you on the proper use of Targretin gel. The following instructions will help you successfully begin and continue your treatment.

Do not use Targretin gel if you are allergic to this medicine. Do not use Targretin gel if you are pregnant or believe you may be pregnant. If you have any of the following conditions, make sure you have discussed them with your doctor before you start to take this medicine. • If you are breast feeding. • If you are allergic to retinoid medications (for example: Accutane [isotretinoin], Soriatane [acitretin], Tegison [etretinate], Vesinoid [tretinoin]).

When should you be extra careful while using Targretin gel? • Because vitamin A in large doses may cause some side effects which are similar to those seen in patients applying Targretin gel, do not take more than the recommended daily dietary allowance of vitamin A (4000 to 5000 International Units). If you take vitamins, check the label to see how much vitamin A they contain. If you are not sure, ask your doctor or pharmacist. • Your skin may become more sensitive to sunlight while using this medicine.

Minimize exposure to sunlight and do not use a sunlamp. WARNINGS For external use only. DO NOT apply the gel on or near mucosal surfaces of the body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus.

DO NOT use insect repellents containing DEET ( N,N -diethyl- m -toluamide) or other products containing DEET while using Targretin gel. Keep out of reach of children. Product contains alcohol and should be kept away from open flame.

DO NOT use Targretin gel if you are pregnant or breastfeeding. Speak to your health care provider if you have any questions or need more information. HOW TO APPLY Apply Targretin gel to your CTCL lesions using a clean washed finger.

Place a generous coating of gel over the entire surface of each lesion. You should not apply gel to the healthy skin around the lesion. The extra effort you take in carefully applying the gel only to the area of the CTCL lesion will help to lessen any irritation or redness that may occur.

Proper application should leave some gel visible on the surface of the lesion when you are finished with the application. Immedia… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL - Carton 60 grams NDC 0187-5525-60 Rx only Targretin ® (bexarotene) 1% gel Net Wt. 60 grams Not for Ophthalmic Use For Topical Use Only Ortho Dermatologics carton.jpg

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 Targretin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Targretin. 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
$886.7K
Claims incl. refills
35
Beneficiaries
20
Spend / beneficiary
$44,334.08
Spend / claim
$25,333.76
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Targretin (this brand).

Top reported reactions

Death76
Hypothyroidism75
Hypertriglyceridaemia59
Disease Progression57
Fatigue50
Pruritus47
Malignant Neoplasm Progression43

Age at onset

Child1
Adult71
Elderly91

Reporter sex

1,309 reports
Male · 57%
Female · 42%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 115 45
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ 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 Bausch Health US, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bausch Health US, 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.
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.