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Desonide .5 mg/g Ointment — NDC 46708-0485-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Desonide .5 mg/g Ointment — NDC 46708-485-15 (Billing 46708-0485-15)

by Alembic Pharmaceuticals Limited · 1 TUBE in 1 CARTON / 15 g in 1 TUBE

This is a package of Desonide .5 mg/g Ointment from Alembic Pharmaceuticals Limited, marketed since Mar 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 46708-0485-15
🏷️ FDA NDC (as labeled) 46708-485-15 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $0.6421/unit — full pricing hub ↓
Main listing for product 46708-485 · Also comes in: 60 g 46708-485-60
Rx only Generic 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46708-485-15
Product NDC 46708-485
11-digit billing NDC 46708048515
RxCUI 204135
UNII J280872D1O
UPC 0346708485153
Application # ANDA212473
SPL Set ID 591762b3-f223-49a1-8e65-63e9086110df
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-07
Route TOPICAL
Dosage form OINTMENT
Substance DESONIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 204135
Why two NDCs? The FDA registers this code as 46708-485-15 — 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 → 46708-0485-15. 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, moderately potent (group II), Corticosteroids, plain
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

📖 What it is MedlinePlus · NLM

Desonide is used to treat the redness, swelling, itching, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Desonide is in a class of medications called topical corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation and itching from skin conditions that respond to steroids. The gel is specifically for mild to moderate eczema (atopic dermatitis) in people 3 months and olde...
  • Put a thin layer on the affected skin and rub it in gently. How many times a day depends on your product, so follow your label and prescriber. Don’t cover the area with tight wraps...
  • Use it for the shortest time that works. The gel should not go past 4 weeks in a row. The cream and ointment should not go past two weeks unless your doctor says so. Stop once your...
  • Mild burning, rash, itching, dryness or irritation where you apply it. Call your doctor if the skin gets worse, thins, looks infected, or if you notice signs of too much steroid in...
📖 Read our full Desonide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Desonide — tap one for details:

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 gPer 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 · Q2 2026 $0.6421 $9.63 / 15 g
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
46708-0485-15 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 g in 1 TUBE 2025-03-07 — Active
46708-0485-60 46708-485-60 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2025-03-07 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of Desonide .5 mg/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Desonide .5 mg/g 00472-0804-15 Actavis 1 tube $0.266 AB Discontinued —
Desonide .5 mg/g 00713-0661-15 Cosette 1 tube $0.306 AB Availability likely —
Desonide .5 mg/g 16714-0729-01 NORTHSTAR 1 tube $0.306 AB Availability likely —
Desonide .5 mg/g 62332-0632-15 Alembic 1 tube $0.306 AB Availability likely —
Desonide .5 mg/g 51672-1280-01 Sun 1 tube $0.306 AB Availability likely —
Desonide .5 mg/g 72578-0086-01 Viona 1 tube $0.306 AB Availability likely —
Desonide Ointment, 0.05% .5 mg/g 21922-0004-04 Encube 1 tube $0.392 AB Availability likely —
Desonide .5 mg/g 45802-0423-35 Padagis 1 tube $0.392 AB Availability likely —
Desonide .5 mg/g 51672-1281-01 Sun 1 tube $0.392 AB Availability likely —
Desonide .5 mg/g 62332-0485-15 Alembic 1 tube $0.392 AB Availability likely —
Desonide .5 mg/g 72603-0164-01 NORTHSTAR 1 tube $0.392 AB Availability likely —
Desonide .5 mg/gthis 46708-0485-15 Alembic 1 tube — AB FDA listed —
Desonide Ointment, 0.05% .5 mg/g 63629-8481-01 Bryant 1 tube — AB FDA listed —
Desonide Ointment, 0.05% .5 mg/g 63629-8482-01 Bryant 1 tube — AB FDA listed —
Desonide Ointment, 0.05% .5 mg/g 72162-1272-02 Bryant 1 tube — AB FDA listed —
Desonide .5 mg/g 24470-0920-60 Cintex 1 tube — — FDA listed —
Desonide .5 mg/g 63187-0747-15 Proficient 1 tube — AB FDA listed —
Desonide .5 mg/g 70771-1381-01 Zydus 1 tube — AB FDA listed —
Desonide .5 mg/g 63629-2506-01 Bryant 1 tube — AB FDA listed —
Desonide .5 mg/g 80425-0418-01 Advanced 1 tube — AB FDA listed —
Desonide .5 mg/g 72162-2005-02 Bryant 1 tube — AB FDA listed —
Desonide .5 mg/g 80425-0371-01 Advanced 1 tube — AB FDA listed —
Desonide .5 mg/g 63629-2507-01 Bryant 1 tube — AB FDA listed —
Desonide .5 mg/g 46708-0632-15 Alembic 1 tube — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
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

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA212473 (ANDA)
Labeler code46708
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio502 products on file
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 40 words ▾

INDICATIONS AND USAGE Desonide ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.

⏱️ Dosage and Administration 66 words ▾

DOSAGE AND ADMINISTRATION Desonide ointment, 0.05% should be applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary. Desonide ointment, 0.05% should not be used with occlusive dressings.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Desonide ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

🤒 Adverse Reactions 104 words ▾

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide ointment, 0.05% was approximately 6%. These adverse reactions were erythema, induration, pruritus, irritation, oiliness, and peripheral edema. The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids.

These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🆘 Overdosage 19 words ▾

OVERDOSAGE Topically applied desonide ointment, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 180 words ▾

CLINICAL PHARMACOLOGY Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called, lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics - The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with desonide ointment, 0.05% indicate that it is in the low range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 19 words ▾

HOW SUPPLIED Desonide Ointment, 0.05% is available as follows: 15 g tube (NDC 46708-485-15) 60 g tube (NDC 46708-485-60)

📦 Storage and Handling 31 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 3/2025

📋 Description 99 words ▾

DESCRIPTION Desonide ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in desonide ointment, 0.05% is C 24 H 32 O 6 .

It has the following structural formula: The molecular weight of desonide is 416.51. It is white to off-white powder. The solubility of desonide in distilled water saturated with the ether is 184 mg/L.

Each gram of desonide ointment, 0.05% contains 0.5 mg of desonide microdispersed in a base of white petrolatum. structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General - Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than two weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppressions. No specific studies relevant to potential HPA suppression have been conducted with desonide ointment, 0.05%.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids.

For information on systemic supplementation, see prescribing information for those products. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS - Pediatric Use ). If irritation develops, desonide ointment, 0.05% should be discontinued and appropriate therapy instituted.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

If a favorable response does not occur promptly, use of desonide ointment, 0.05% should be discontinued until the infection has been adequately controlled. Desonide ointment, 0.05% should not be used in the presence of infection at the treatment site, hypersensitivity to corticosteroids, or pre-existing skin atrophy. Desonide ointment, 0.05% should not be used in the eyes.

FOR EXTERNAL USE ONLY. Information for Patients Patients using topical corticosteroids 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 eyes. 2.

This medication should not be used for any disorder other than that for which it was prescribed. 3. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.

4. Patients should report to their physician any signs of local adverse reactions. Laboratory Tests – The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test A.M. plasma cortisol test Urinary free cortisol test Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term animal studies have not been performed to evaluate the carcinogenic, mutagenic, or fertility impairment potential of desonide ointment, 0.05%.

Pregnancy: Teratogenic Effects: Pregnancy Category C – Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproductive studies have not been conducted with desonide ointment, 0.05%.

It is also not known whether desonide ointment, 0.05% can cause fetal harm when administered to a pregnan… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 50 words ▾

PRINCIPAL DISPLAY PANEL TUBE Rx Only NDC 46708-485-15 Desonide Ointment, 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE NET WT 15 grams tube image

PRINCIPAL DISPLAY PANEL CARTON Rx Only NDC 46708-485-15 Desonide Ointment, 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE NET WT 15 grams carton image

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 Desonide — the program that covers self-administered drugs. 9 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 Desonide. 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
$2.45M
Claims incl. refills
55.6K
Beneficiaries
48.4K
Spend / beneficiary
$50.71
Spend / claim
$44.15
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.

About this NDC listing & data coverage

Finished prescription product
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) ✓ 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 ✓ Available
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

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 Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (46708-0485-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited 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.
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.