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Triadermex Triamcinolone Acetonide Kit — NDC 84460-0100-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Triadermex Triamcinolone Acetonide Kit — NDC 84460-100-08 (Billing 84460-0100-08)

by Florrax Pharmaceutical · 1 KIT in 1 KIT * 80 g in 1 TUBE

This is a package of Triadermex Triamcinolone Acetonide Kit from Florrax Pharmaceutical, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 84460-0100-08
🏷️ FDA NDC (as labeled) 84460-100-08 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 20, 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 84460-100-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
84460 labeler · 100 product · 08 package
Package marketed since
Jun 13, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8446010008 2
FDA record last changed
Aug 20, 2026
⚠️
Other active recalls for Triamcinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84460-100-08
Product NDC 84460-100
11-digit billing NDC 84460010008
NCPDP billing unit EA — each (per item)
RxCUI 1014314
SPL Set ID 3bda5cd1-df3c-4b4c-9868-cbc41f66f5a6
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-13
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1014314
Why two NDCs? The FDA registers this code as 84460-100-08 — 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 → 84460-0100-08. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Injections treat severe allergic conditions, joint inflammation, certain skin problems and eye inflammation. Creams and ointments calm itchy, inflamed sk...
  • Injections are given by a healthcare professional. Ointment is applied as a thin film to the affected area two to three times daily. Nasal spray bottles need priming before first u...
  • Possible effects include injection site pain, joint swelling, headache, muscle spasms, cough, sinusitis and bruising. People with diabetes may see higher blood sugar. Tell your doc...
  • Call right away for signs of an allergic reaction, fever or infection, a very painful and swollen joint, vision changes, or mood changes. Also report black stools, severe stomach p...
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Triamcinolone Acetonide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
84460-0100-08 You're viewing this Main listing 1 KIT in 1 KIT * 80 g in 1 TUBE 2025-06-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamcinolone Acetonide 1 mg/g 45802-0064-05 Padagis 454 g $0.027 AT Availability likely —
triamcinolone acetonide 1 mg/g 00168-0004-15 E. 1 tube $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 00713-0225-15 Cosette 1 tube $0.102 AT Discontinued —
Triamcinolone Acetonide 1 mg/g 16714-0986-01 NorthStar 1 tube $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 21922-0062-04 Encube 1 tube $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 33342-0329-15 Macleods 1 tube $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 51672-1282-01 Sun 1 tube $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 67877-0251-15 Ascend 15 g $0.102 AT Availability likely —
Triamcinolone Acetonide 1 mg/g 71656-0042-15 Saptalis 1 tube $0.102 AT Availability likely —
Triderm 1 mg/g 00316-0170-01 Crown 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-0162-00 A-S 80 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-0228-00 A-S 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 50090-2106-00 A-S 30000 mg — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-6547-00 A-S 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 50090-6566-00 A-S 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 52817-0811-15 TruPharma, 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 61919-0234-30 Direct_Rx 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 61919-0650-15 DIRECTRX 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63187-0025-15 Proficient 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63187-0053-15 Proficient 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63187-0870-15 Proficient 1 tube — — FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8778-01 Bryant 15 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8779-01 Bryant 30 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8780-01 Bryant 80 g — AT FDA listed —
Triamcinolone acetonide 1 mg/g 63629-8781-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63629-9573-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 63629-9574-01 Bryant 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 66267-0933-80 NuCare 80 g — — FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-2736-03 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3666-03 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3852-08 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-3982-05 NuCare 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-4383-05 NuCare 15 g — — FDA listed —
triamcinolone acetonide 1 mg/g 68071-4391-03 NuCare 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68071-4945-05 NuCare 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68462-0131-17 Glenmark 1 tube — — FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-7797-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8350-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8356-00 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 68788-8753-01 Preferred 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-1524-00 REMEDYREPACK 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2285-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2403-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 70518-2963-00 REMEDYREPACK 1 tube — AT Discontinued —
Triamcinolone Acetonide 1 mg/g 70518-4527-00 REMEDYREPACK 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71205-0627-15 Proficient 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 71335-2211-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71335-2712-01 Bryant 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 71335-2713-01 Bryant 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72162-1386-04 Bryant 1 tube — AT FDA listed —
Triamcinolone acetonide 1 mg/g 72162-1832-03 Bryant 30 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0039-80 Direct_Rx 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0277-15 Direct_Rx 15 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0330-80 Direct 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0571-80 Direct_rx 80 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 72189-0670-30 Direct_rx 30 g — AT FDA listed —
Dermavyx 72835-0777-02 V2 1 kit — — FDA listed —
Triamcinolone Acetonide 1 mg/g 76420-0203-15 Asclemed 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 76420-0348-00 Asclemed 454 g — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 82804-0071-30 Proficient 1 tube — AT FDA listed —
Triamcinolone Acetonide 1 mg/g 82804-0145-30 Proficient 1 tube — AT FDA listed —
Triadermexthis 84460-0100-08 Florrax 1 kit — — FDA listed —
Triasil 59088-0730-00 PureTek 1 kit — — FDA listed —
Trilona 73086-0104-60 Skya 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

🧪 Avoiding an ingredient? See Triamcinolone 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerFlorrax Pharmaceutical
Labeler code84460
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from Florrax Pharmaceutical labeler code 84460

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 19 words ▾

INDICATIONS & USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

⏱️ Dosage and Administration 74 words ▾

DOSAGE & ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 60 words ▾

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

🆘 Overdosage 14 words ▾

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

🧬 Clinical Pharmacology 188 words ▾

CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses .

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids and their metabolites are also excreted into the bile.

📦 How Supplied / Storage and Handling 48 words ▾

HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.1%, 80 g - (1 Tube) 80 grams tube NDC84460-0100-08 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Packaged for: Florrax Pharma LLC Dallas TX 75228 Questions or Comments Call: (833) 242-4493

📋 Description 78 words ▾

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

Structure

📄 Package Label / Principal Display Panel 163 words ▾

PRINCIPAL DISPLAY PANEL - Label NDC:84460-100-08 Triadermex TM Rx Only Kit Includes: Triamcinolone Acetonide Cream USP, 0.1%, 80 g - (1 Tube) Silicone Tape Roll - (1 Roll) Sterile Gauze Pads - (20 count) Triamcinolone Acetonide Cream USP Each gram contains 1 mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Usual Dosage: 2 to 3 applications daily. See package insert for full prescribing information.

TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. See enclosed insert for full prescribing information.

Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Keep this and all medication out of reach of children. For external use only.

Not for ophthalmic use. Packaged for: Florrax Pharma LLC Dallas, TX 75228 Questions or Comments Call: (833) 242-4493 pdp pdp

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 Triamcinolone Acetonide (matched by generic name) — the program that covers self-administered drugs. 22 manufacturers.
⚠️ 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 Triamcinolone Acetonide. CMS lists 5 products for this generic; we show the highest-spend one. 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
$17.79M
Claims incl. refills
1.7M
Beneficiaries
1.4M
Spend / beneficiary
$13.01
Spend / claim
$10.45
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 Triadermex (this brand).

Top reported reactions

Pruritus2,512
Rash2,412
Pain2,036
Fatigue1,939
Nausea1,851
Vomiting1,625
Diarrhoea1,604

Age at onset

Neonate11
Infant49
Child598
Adolescent456
Adult4,959
Elderly2,219

Reporter sex

23,258 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,047
Death3,020
Life-threatening2,329
Disabling2,312
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,836 0
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 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 ✓ Available
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 Florrax Pharmaceutical. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Florrax Pharmaceutical 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.
← 84458-0002-01 · Dongguan 84460-0103-01 · Florrax →
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.