Calcipotriene .05 mg/mL Solution — NDC 0713-0318-53 (Billing 00713-0318-53)
This is a package of Calcipotriene .05 mg/mL Solution from Cosette Pharmaceuticals, Inc., marketed since Mar 2011 and currently FDA-listed; retail pharmacies pay about $2.71 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0713-0318-53 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0713 labeler · 0318 product · 53 package
- Package marketed since
- Mar 24, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0307130318532
- Medicaid fills, this package
- 12,959 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): 022483
- GCN: 01852
- GPI-14 (Medi-Span): 90250025002020
- HICL (First Databank): 013331
- AHFS class code: 84:24.12.00
- RxCUI (RxNorm): 308865
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
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 ↗- 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.712 | $162.70 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | $3.33 | $200.00 / 60 ml |
| Medicare drug plans payPart D · Q2 2026 | $3.63 | $217.98 / 60 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 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 | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00713-0318-53 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE | 2011-03-24 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Calcipotriene .05 mg/mLthis 00713-0318-53 | Cosette | 1 bottle | $2.712 | AT | Availability likely | — |
| Pellix .05 mg/mL 87143-0300-60 | Perfero | 1 bottle | — | AT | 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 Sep 30, 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 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.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
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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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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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.
6 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 Cosette Pharmaceuticals, Inc. labeler code 00713
- Triamcinolone Acetonide 1 mg/g Cream NDC 0713-0225-15
- Triamcinolone Acetonide .25 mg/g Cream NDC 0713-0226-15
- Triamcinolone Acetonide 1 mg/g Ointment NDC 0713-0228-15
- Triamcinolone Acetonide .25 mg/g Ointment NDC 0713-0229-15
- Triple Antibiotic Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate 5000 [USP'U]/g; 3.5 mg/g; 400 [USP'U]/g Ointment NDC 0713-0268-31
- Bacitracin 500 [USP'U]/g Ointment NDC 0713-0280-31
- Betamethasone Valerate 1.2 mg/g Cream NDC 0713-0326-15
- Betamethasone Valerate 1.2 mg/g Ointment NDC 0713-0327-15
- Halobetasol Propionate .5 mg/g Ointment NDC 0713-0339-15
- Prochlorperazine Edisylate 5 mg/mL Injection NDC 0713-0351-09
- Betaine 1 g/g Powder, For Solution NDC 0713-0352-81
- Docosanol 100 mg/g Cream NDC 0713-0353-02
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 Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Comb the hair to remove scaly debris and after suitably parting, apply Calcipotriene Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Calcipotriene Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks. Keep Calcipotriene Topical Solution, 0.005% (Scalp Solution), well away from the eyes.
Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.
⛔ Contraindications ▾
CONTRAINDICATIONS Calcipotriene Topical Solution, 0.005% (Scalp Solution), is contraindicated in those patients with acute psoriatic eruptions or 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.
⚠️ Warnings and Cautions ▾
PRECAUTIONS General Use of Calcipotriene Topical Solution, 0.005% (Scalp Solution), may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Calcipotriene Topical Solution, 0.005% (Scalp Solution), 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 topical 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 Topical Solution, 0.005% (Scalp Solution) should receive the following information and instructions: 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. This medication should not be used for any disorder other than that for which it was prescribed.
Patients should report to their physician any signs of adverse reactions. Patients that apply Calcipotriene Topical Solution, 0.005% (Scalp Solution) 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 μg/kg/day (corresponding to 9, 30 and 90 μg/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 Topical Solution, 0.005% (Scalp Solution) 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 limit or avoid use of phototherapy in patients that use Calcipotriene Topical Solution, 0.005% (Scalp Solution). 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 μg/kg/day (324 μg/m 2 /day) of calcipotriene indicated no impairment of fertility or general reproductive performance.
Pregnancy Teratogenic Effects: Pregnancy Category C Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 μg/kg/day (132 μg/m 2 /day). Rabbits administered 36 μg/kg/day (396 μg/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 μg/kg/day (318 μg/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 μg/m 2 /day) and rabbit (17.6 μg/m 2 /day) studies are greater than the expected human systemic exposure level (0.13 μg/m 2 /day) from dermal application.
There are no adequate and well-controlled studies in pregnant women. Therefore, Calcipotriene Topical Solution, 0.005% (Scalp Solution), should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers There is evidence that maternal 1,25-dihydroxy vitamin D 3 (calcitriol)… [Excerpted — this section continues on DailyMed.]
⚠️ Warnings ▾
WARNINGS Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Drug product is flammable. Keep away from open flame.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported to be related to Calcipotriene Topical Solution, 0.005% (Scalp Solution), use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients.
Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🆘 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 . Although the precise mechanism of calcipotriene’s antipsoriatic action is not fully understood, in vitro evidence suggests that calcipotriene is roughly equipotent to the natural vitamin in its effects on proliferation and differentiation of a variety of cell types.
Calcipotriene has also been shown, in animal studies, to be 100-200 times less potent in its effects on calcium utilization than the natural hormone. Clinical studies with radiolabelled calcipotriene solution indicate that less than 1% of the applied dose of calcipotriene is absorbed through the scalp when the solution (2.0 mL) is applied topically to normal skin or psoriasis plaques (160 cm 2 ) for 12 hours, and that much of the absorbed calcipotriene 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 Topical Solution, 0.005% (Scalp Solution) is available in 60 mL plastic bottles (NDC 0713-0318-53).
📦 Storage and Handling ▾
STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid sunlight. Do not freeze. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0318CPLNC1 VC7535 Iss. 02/2021
📋 Description ▾
DESCRIPTION Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water. The chemical name of calcipotriene 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 412.6, and the following structural formula: formula
🔬 Clinical Studies ▾
CLINICAL STUDIES Adequate and well-controlled trials of patients treated with Calcipotriene Topical Solution, 0.005% (Scalp Solution) have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 31% of patients appearing either cleared (14%) or almost cleared (17%) after 8 weeks of therapy.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0713-0318-53 Calcipotriene Topical Solution, 0.005% (Scalp Solution) 60 mL Rx only For Topical Dermatologic Use Only - Not for Ophthalmic, Oral or Intravaginal Use. Cosette Pharmaceuticals, Inc. label tube tube-b