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Trionex Calcipotriene Cream, 0.005% and Transparent Dressing Kit — NDC 72835-902-02 (Billing 72835-0902-02)

by V2 Pharma, LLC · 1 KIT in 1 CARTON * 1 TUBE in 1 CARTON / 60 g in 1 TUBE * 10 in 1 BOX

This is a package of Trionex Calcipotriene Cream, 0.005% and Transparent Dressing Kit from V2 Pharma, LLC, marketed since Jan 2023 and currently FDA-listed. It is this product's only package size.

NDC 72835-0902-02
🏷️ FDA NDC (as labeled) 72835-902-02 billing pads the product segment with a zero
Rx only 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 72835-902-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72835 labeler · 902 product · 02 package
Package marketed since
Jan 13, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0368462501658
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72835-902-02
Product NDC 72835-902
11-digit billing NDC 72835090202
NCPDP billing unit EA — each (per item)
RxCUI 313921
UPC 0368462501658
SPL Set ID 45ac2edf-7ed1-4862-888a-f9dd349f1930
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-13
Dosage form KIT

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

GCN Seq No 084494
GCN 53805
HICL code 048757
Ingredient (HICL) Calcipotriene/Dressing
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5F
Therapeutic class — specific (HIC3) Antipsoriatics Agents
AHFS code 84:32.00.00
AHFS class Keratoplastic Agents
FDB label name TRIONEX 0.005% KIT
FDB brand name Trionex
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084494
  • GCN: 53805
  • HICL (First Databank): 048757
  • AHFS class code: 84:32.00.00
  • RxCUI (RxNorm): 313921
Why two NDCs? The FDA registers this code as 72835-902-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72835-0902-02. 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 Vitamin D Analog class.

Pharmacologic class Vitamin D Analog
Drug family (ATC) Other antipsoriatics for topical use
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 TRIONEX 0.005% KIT Ingredient Calcipotriene/Dressing
📗 Our plain-language guide HelloPharmacist
  • 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.
📖 Read our full Calcipotriene Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
72835-0902-02 You're viewing this Main listing 1 KIT in 1 CARTON * 1 TUBE in 1 CARTON / 60 g in 1 TUBE * 10 in 1 BOX 2023-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
calcipotriene 50 ug/g 16714-0763-01 Northstar 1 tube $1.056 AB Availability likely —
Calcipotriene 50 ug/g 66993-0877-61 Prasco 1 tube $1.056 AB Availability likely —
calcipotriene 50 ug/g 68462-0501-65 Glenmark 1 tube $1.056 AB Availability likely —
Trionexthis 72835-0902-02 V2 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerV2 Pharma, LLC
Labeler code72835
First marketedJan 2023
Product typeHuman Prescription Drug
Portfolio13 products on file

More NDCs from V2 Pharma, LLC labeler code 72835

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

INDICATION AND USAGE Indicated for the treatment of plaque psoriasis.

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 97 words ▾

DOSAGE AND ADMINISTRATION Apply a thin layer of calcipotriene cream to the affected skin 1-2 times daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks. Once calcipotriene has been completely rubbed in completely, apply transparent dressing to the affected area as needed as a protectant.

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 68 words ▾

CONTRAINDICATIONS Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

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 29 words ▾

WARNINGS FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes.

WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.

🤒 Adverse Reactions 101 words ▾

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.

🤰 Pregnancy 194 words ▾

PREGNANCY If pregnant or breast feeding, ask a health professional before use.

Pregnancy Teratogenic Effects: Pregnancy Category C 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 46 words ▾

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 59 words ▾

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 44 words ▾

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 165 words ▾

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.

📦 How Supplied / Storage and Handling 20 words ▾

Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.]

📦 Storage and Handling 190 words ▾

Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.]

HOW SUPPLIED Calcipotriene cream, 0.005% is available in: NDC 68462-501-65 60 gram tube (1 tube per carton) NDC 68462-501-66 120 gram tube (1 tube per carton) 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. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions?

1 (888) 721-7115 www.glenmarkpharma-us.com 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. March 2021 glen-logo

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. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions?

1 (888) 721-7115 www.glenmarkpharma-us.com 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. March 2021 glen-logo

📋 Description 127 words ▾

TRIONEX DESCRIPTION TRIONEX is supplied as 4 components in a kit : -1 TUBE OF CALCIPOTRIENE CREAM 0.005%, 60g (NDC 68462-501-65) - 30 SHEETS OF HYDROFILM TRANSPARENT DRESSING (3 BOXES OF 10 SHEETS)

DESCRIPTION Calcipotriene cream, 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 g/mol and the following structural formula: Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene cream, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, cetostearyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum. structural-formula

💬 Information for Patients 110 words ▾

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.).

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. PREGNANCY If pregnant or breast feeding, ask a health professional before use.

PRECAUTIONS General Use of calcipotriene cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, calcipotriene cream 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 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.).

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 cream 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 cream. 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: Pregnancy Category C 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.

Nursing… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 67 words ▾

Nursing Mothers 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. Because many drugs are excreted in human milk, caution should be exercised when calcipotriene cream is administered to a nursing woman.

🔬 Clinical Studies 54 words ▾

CLINICAL STUDIES Adequate and well-controlled trials of patients treated with calcipotriene cream have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 197 words ▾

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 cream 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 cream. 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 16 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton V2 Pharma, LLC TRIONEX NDC 72835-902-02 RX ONLY Trionex Packaging

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

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application Kit / multi-component package

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
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 V2 Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
V2 Pharma, 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.
← 72835-0777-02 · V2
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.