Calcipotriene 50 ug/g Ointment, 60 g — NDC 68462-310-65 (Billing 68462-0310-65)
This is a package of 60 g of Calcipotriene 50 ug/g Ointment from Glenmark Pharmaceuticals Inc., USA, marketed since Mar 2010 and currently FDA-listed; retail pharmacies pay about $2.08 per g (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 68462-310-65 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 68462 labeler · 310 product · 65 package
- Package marketed since
- Mar 24, 2010
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 60 g per package
- Barcode (UPC)
- 0368462310656
- Medicaid fills, this package
- 9,489 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
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 019160
- GCN: 01850
- GPI-14 (Medi-Span): 90250025004210
- HICL (First Databank): 013331
- AHFS class code: 84:24.12.00
- RxCUI (RxNorm): 198373
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Vitamin D Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats plaque psoriasis. The foam is for the scalp and body in adults and children 4 and older. Pellix is a scalp solution.
- Comb your hair to remove scales and part it. Apply it twice daily only to the lesions and rub it in gently. Keep it off your forehead and away from your eyes, and wash your hands a...
- How do I apply the Pellix scalp solution?
- Mild redness, pain or itching where you apply it are the most common. Call me or your doctor if irritation gets excessive or you have a sensitivity reaction.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Calcipotriene — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $2.084 | $125.06 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $2.34 | $140.15 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $2.68 | $161.00 / 60 g |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 68462-0310-65 You're viewing this Main listing | 60 g in 1 TUBE | $2.08 / g | $125.06 | 2010-03-24 | — | Active |
| 68462-0310-66 68462-310-66 | 1 TUBE in 1 CARTON / 120 g in 1 TUBE | $2.34 / g | $280.52 | 2010-03-24 | — | Active |
This pack has the lowest per-g cost of the 2 priced pack sizes ($2.08 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Calcipotriene 50 ug/g Ointment?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Calcipotriene 50 ug/g 66993-0877-61 | Prasco | 1 tube | $1.056 | AB | Availability likely | save 49% |
| calcipotriene 50 ug/g 68462-0501-65 | Glenmark | 1 tube | $1.056 | AB | Availability likely | save 49% |
| calcipotriene 50 ug/g 16714-0763-01 | Northstar | 1 tube | $1.056 | AB | Availability likely | save 49% |
| calcipotriene 50 ug/g 66993-0878-61 | Prasco | 1 tube | $2.084 | AB | Availability likely | — |
| Calcipotriene 50 ug/gthis 68462-0310-65 | Glenmark | 60 g | $2.084 | AB | Availability likely | — |
| Calcipotriene .05 mg/g 51672-4154-03 | Sun | 1 tube | $2.268 | AB | FDA listed | +9% |
| Calcitrene .05 mg/g 51672-5278-03 | Sun | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 Calcipotriene Topical 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.
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UNII H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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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 V56DFE46J5
Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
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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.
8 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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Glenmark Pharmaceuticals Inc., USA labeler code 68462
- HEATHER Norethindrone .35 mg Tablet NDC 68462-303-29
- Norethindrone Acetate 5 mg Tablet NDC 68462-304-05
- Norethindrone .35 mg Tablet NDC 68462-305-29
- Dimethyl Fumarate 120 mg Capsule NDC 68462-307-05
- Dimethyl Fumarate 240 mg Capsule NDC 68462-308-05
- Norgestimate and Ethinyl Estradiol Kit NDC 68462-309-29
- Nystatin and Triamcinolone Acetonide 100000 [USP'U]/g; 1 mg/g Cream NDC 68462-314-17
- BRIELLYN Norethindrone and Ethinyl Estradiol Kit NDC 68462-316-29
- Fulvestrant 50 mg/mL Injection NDC 68462-317-32
- VIORELE Desogestrel and Ethinyl Estradiol Kit NDC 68462-318-29
- Ranolazine 500 mg Tablet, Film Coated, Extended Release NDC 68462-319-05
- Ranolazine 1000 mg Tablet, Film Coated, Extended Release NDC 68462-320-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. 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 ointment USP, 0.005% once or twice daily and rub in gently and completely.
⛔ Contraindications ▾
CONTRAINDICATIONS Calcipotriene 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 should not be used on the face.
⚠️ Warnings ▾
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trials Experience In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10 to 15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis.
Once daily dosing has not been shown to be superior in safety to twice daily dosing. Postmarketing Experience The following adverse reactions have been identified during post approval use of Dovonex Ointment. 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.
Renal and urinary disorders: hypercalciuria Skin and subcutaneous tissue disorders: application site edema, application site pain, contact dermatitis (including allergic contact dermatitis), depigmentation, hypopigmentation, photosensitivity, rash (including erythematous, maculo-papular, and pustular), and urticaria.
🤰 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. In rabbits, increased maternal and fetal toxicity were noted at a dosage 12 mcg/kg/day (132 mcg/m 2 /day); a dosage of 36 mcg/kg/day (396 mcg/m 2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (318 mcg/m 2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs).
The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels 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 ointment 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 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 ointment, USP approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).
🆘 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 calcipotriene ointment USP, 0.005%.
🧬 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, USP 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.
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.
The primary metabolites are much less potent than the parent compound. There is evidence that maternal 1,25-dihydroxy vitamin D 3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Calcipotriene Ointment USP, 0.005% is available in: 60 gram aluminum tube NDC (68462-310-65) 120 gram aluminum tube NDC (68462-310-66)
📦 Storage and Handling ▾
STORAGE Store at controlled room temperature 15°C to 25°C (59°F to 77°F). Do not freeze. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888)721-7115 www.glenmarkpharma-us.com November 2025 glenmarklogo
📋 Description ▾
DESCRIPTION Calcipotriene Ointment USP, 0.005% contains the compound calcipotriene, USP a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, Calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-trioI; 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 Ointment USP, 0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, white petrolatum, propylene glycol, dl-alpha-tocopherol , steareth-2 and purified water. structure
💬 Information for Patients ▾
Information for Patients Patients using calcipotriene should receive the following information and instructions: 1. This medication is to be used 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 local adverse reactions.
4. Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight. (including tanning booths, sun lamps, etc.)
⚠️ Precautions ▾
PRECAUTIONS General Use of calcipotriene may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, calcipotriene should be discontinued. For external use only.
Keep out of the reach of children. Always wash hands thoroughly after use. Reversible elevation of serum calcium has occurred with use of calcipotriene.
If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored. Information for Patients Patients using calcipotriene should receive the following information and instructions: 1. This medication is to be used 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 local adverse reactions. 4. Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight.
(including tanning booths, sun lamps, etc.) Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m 2 /day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.
Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to avoid use of phototherapy in patients that use calcipotriene ointment USP, 0.005%. Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.
Studies in rats at doses up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance. 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. In rabbits, increased maternal and fetal toxicity were noted at a dosage 12 mcg/kg/day (132 mcg/m 2 /day); a dosage of 36 mcg/kg/day (396 mcg/m 2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses.
In a rat study, a dosage of 54 mcg/kg/day (318 mcg/m 2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels 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 ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether calcipotriene is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when calcipotriene ointment, 0.005% is administered to a nursing woman. Pediatric Use Safety and effectiveness of calcipotriene in pediatric patients have not been established. Because of a higher ratio of skin surface area to… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when calcipotriene ointment, 0.005% is administered to a nursing woman.
🔬 Clinical Studies ▾
CLINICAL STUDIES Adequate and well-controlled trials of patients treated with calcipotriene ointment USP, 0.005% have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued in patients using calcipotriene once daily and twice daily. After 8 weeks of once daily calcipotriene, 56.7% of patients showed at least marked improvements (6.4% showed complete clearing).
After 8 weeks of twice daily calcipotriene, 70% of patients showed at least marked improvement (11.3% showed complete clearing). Subtracting percentages of patients using placebo (vehicle only) from percentages of patients using calcipotriene who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. This adjustment for placebo effect indicates that what might appear to be differences between once and twice daily use may reflect differences in the studies independent from the frequency of dosing.
Although there was a numerical difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing. Over 400 patients have been treated in open label clinical studies of calcipotriene for periods of up to one year. In half of these studies, patients who previously had not responded well to calcipotriene were excluded.
The adverse reaction in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. In one of these open label studies, half of the patients no longer required calcipotriene by 16 weeks of treatment, because of satisfactory therapeutic results.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m 2 /day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors.
Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to avoid use of phototherapy in patients that use calcipotriene ointment USP, 0.005%. Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.
Studies in rats at doses up to 54 mcg/kg/day (324 mcg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL tubelabel60g