calcipotriene 50 ug/g Cream
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Vitamin D Analog class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Calcipotriene is used to treat psoriasis (a skin disease in which red, scaly patches form due to increased production of skin cells on some areas of the body). Calcipotriene is in a class of medications called synthetic vitamin D3 derivatives. It works by slowing the excessive production of skin cells.
Read the full MedlinePlus article ↗- Calcipotriene is not a steroid at all — it's a synthetic form of vitamin D3. While steroid creams work by suppressing inflammation, calcipotriene is thought to work by binding to v...
- What exactly is calcipotriene, and how is it different from a steroid cream?
- No — calcipotriene should not be applied to the face. The label is clear on this for all product forms. If you have psoriasis on your face, talk to your dermatologist about other o...
- Can I use this on my face if my psoriasis is there too?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Calcipotriene — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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UNII I835H2IHHX
A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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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.
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UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII 94255I6E2T
Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
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UNII 593YOG76RN
A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
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Can inactive ingredients matter?
💲 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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.087 | $65.24 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $1.34 | $80.21 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $1.86 | $111.75 / 60 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| calcipotriene 50 ug/g 16714-0763-01 | Northstar | 1 tube | $1.087 | AB | Availability likely | — |
| Calcipotriene 50 ug/g 66993-0877-61 | Prasco | 1 tube | $1.087 | AB | Availability likely | — |
| calcipotriene 50 ug/gthis 68462-0501-65 | Glenmark | 1 tube | $1.087 | AB | Availability likely | — |
| calcipotriene 50 ug/g 66993-0878-61 | Prasco | 1 tube | $2.123 | AB | Availability likely | +95% |
| Calcipotriene 50 ug/g 68462-0310-65 | Glenmark | 60 g | $2.123 | AB | Availability likely | +95% |
| Trionex 72835-0902-02 | V2 | 1 kit | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68462-0501-65 You're viewing this | 1 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBE | $1.09 / g | $65.24 | 2015-06-10 | Active |
| 68462-0501-66 | 1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE | $1.04 / g | $124.83 | 2015-06-10 | Active |
Per g, this pack runs about 5% above the cheapest pack (NDC 68462-0501-66, $1.04 vs $1.09 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 89% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68462-0501-65?
What NDC number is used to bill for this package of calcipotriene 50 ug/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin layer of calcipotriene cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.
⛔ Contraindications ▾
CONTRAINDICATIONS Calcipotriene cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene cream should not be used on the face.
⚠️ Warnings ▾
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trials Experience In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. Postmarketing Experience 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.
The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis. To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40 to 60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m 2 /day). Rabbits administered 36 mcg/kg/day (396 mcg/m 2 /day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification.
In a rat study, oral doses of 54 mcg/kg/day (318 mcg/m 2 /day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 mcg/m 2 /day) and rabbit (17.6 mcg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m 2 /day) from dermal application.
There are no adequate and well-controlled studies in pregnant women. Therefore, calcipotriene cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of calcipotriene cream in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.
🧓 Geriatric Use ▾
Geriatric Use Of the total number of patients in clinical studies of calcipotriene cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.
🆘 Overdosage ▾
OVERDOSAGE Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D 3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D 3 . Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application.
Systemic absorption of the cream has not been studied. Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D 3 (calcitriol), is known to be recycled via the liver and excreted in the bile.
Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone.
📦 Storage and Handling ▾
HOW SUPPLIED Calcipotriene cream USP, 0.005% is available in: 60 gram tube (1 tube per carton), NDC 68462-501-65 120 gram tube (1 tube per carton), NDC 68462-501-66 STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?
1 (888) 721-7115 www.glenmarkpharma-us.com March 2025 glenmarklogo
STORAGE Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com March 2025 glenmarklogo
📋 Description ▾
DESCRIPTION Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 derivative, for topical dermatological use. Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.62 and the following structural formula: Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum. structuralformula
💬 Information for Patients ▾
Information for Patients Patients using calcipotriene cream should receive the following information and instructions: 1. This medication is to be used only as directed by the physician. It is for external use only.
Avoid contact with the face or eyes. As with any topical medication, patients should wash their hands after application. 2.
This medication should not be used for any disorder other than that for which it was prescribed. 3. Patients should report to their physician any signs of adverse reactions.
4. Patients that apply calcipotriene cream to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).