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Urea 40% 400 mg/g Cream, 1 bottle — NDC 39328-0019-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Urea 40% 400 mg/g Cream, 1 bottle — NDC 39328-019-01 (Billing 39328-0019-01)

by Patrin Pharma, Inc · 1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC

This is a package of 1 bottle of Urea 40% 400 mg/g Cream from Patrin Pharma, Inc, marketed since Oct 2025 and currently FDA-listed; retail pharmacies pay about $1.05 per g (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 39328-0019-01
🏷️ FDA NDC (as labeled) 39328-019-01 billing pads the product segment with a zero
This package
Contains1 bottle Cost per g$1.05 NADAC Per package$29.73 / 28.35 g Pack sizes3 compare ↓
Main listing for product 39328-019 · Also comes in: 85 g 39328-019-03 198.4 g 39328-019-07
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 39328-019-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
39328 labeler · 019 product · 01 package
Package marketed since
Oct 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 3932801901 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 39328-019-01
Product NDC 39328-019
11-digit billing NDC 39328001901
NCPDP billing unit GM — per gram (weight)
RxCUI 198342
UNII 8W8T17847W
SPL Set ID 53ccf801-c1c6-42c8-a511-da33c308076f
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-01
Route TOPICAL
Dosage form CREAM
Substance UREA

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

GPI-14 90660080003725
GCN Seq No 016308
GCN 24774
HICL code 002716
Ingredient (HICL) Urea
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 24:36.12.00
AHFS class Osmotic Diuretics (24:36)
FDB label name UREA 40% CREAM
FDB brand name Urea
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016308
  • GCN: 24774
  • GPI-14 (Medi-Span): 90660080003725
  • HICL (First Databank): 002716
  • AHFS class code: 24:36.12.00
  • RxCUI (RxNorm): 198342
Why two NDCs? The FDA registers this code as 39328-019-01 — 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 → 39328-0019-01. 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 Helicobacter pylori Diagnostic class.

Pharmacologic class Helicobacter pylori Diagnostic
Drug family (ATC) Solutions producing osmotic diuresis, Carbamide products, Other diagnostic agents
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 UREA 40% CREAM Ingredient Urea
📗 Our plain-language guide HelloPharmacist
  • It softens thick, dry, scaly skin. Providers use it for conditions like psoriasis, eczema, ichthyosis, calluses, and damaged or ingrown nails. It can also help clear dead tissue fr...
  • Most urea creams on the label are applied twice a day, or as your prescriber directs. Rub it in until it is fully absorbed. Wash your hands first. Avenaster Fungal Nail Care Duo Se...
  • It can. Some people notice temporary stinging, burning, itching or irritation, which usually fades once you stop using it. If you get redness, a rash, or things get worse, stop and...
  • No. It is for external use only. Keep it away from your eyes, lips and the inside of your nose or mouth. If it is swallowed, call Poison Control or get medical help right away.
📖 Read our full Urea guide →
7
Nutrient depletion considerations

Urea may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Urea 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 gPer package
Retail pharmacies payNADAC · weekly $1.049 $29.73 / 28.35 g
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.
NADAC price history (per g) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.096 $1.037
▼ Down 4% over the last 10 months.
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 Per unit Per pack Marketing startMarketing endStatus
39328-0019-01 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC $1.05 / g $29.73 2025-10-01 — Active
39328-0019-03 39328-019-03 85 g in 1 BOTTLE, PLASTIC $0.2687 / g $22.84 2025-10-01 — Active
39328-0019-07 39328-019-07 198.4 g in 1 BOTTLE, PLASTIC $0.1462 / g $29.01 2025-10-01 — Active

Per g, this pack runs about 617% above the cheapest pack (198.4 g in 1 BOTTLE, PLA, $0.1462 vs $1.05 NADAC).

Pack size FAQ

What quantity is in this package?
This package contains 1 bottle — 1 bottle, plastic in 1 carton / 28.35 g in 1 bottle, plastic.
How does this package differ from NDC 39328-0019-03?
Both are Urea 40% 400 mg/g Cream — the drug itself is identical. This page's package is the 1 bottle one, while NDC 39328-0019-03 is the 85 g package. Per-g NADAC also differs: $1.05 here vs $0.2687 for the 85 g pack.
What NDC number is used to bill for this package of Urea 40% 400 mg/g Cream?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Urea 40% 400 mg/gthis 39328-0019-01 Patrin 1 bottle $1.049 — Availability likely —
Urea 40 g/100g 50268-0872-28 AvPAK 28.35 g $1.049 — Availability likely —
Urea Cream 40 Percent 400 mg/g 58657-0489-01 Method 28.35 g $1.049 — Availability likely —
Urea 40 Percent 400 mg/g 58657-0487-01 Method 28.35 g $1.382 — FDA listed +32%
Urea Cream 40% 400 mg/g 16477-0340-01 Laser 1 bottle — — FDA listed —
Urea 400 mg/g 24470-0939-01 Cintex 1 bottle — — FDA listed —
Urea 400 mg/g 44523-0617-01 BioComp 1 bottle — — FDA listed —
Urea 40 Percent 400 mg/g 63629-9267-01 Bryant 198.4 g — — FDA listed —
Urea Cream 40 Percent 400 mg/g 71335-2868-01 Bryant 28.35 g — — FDA listed —
Urea 40 Percent 400 mg/g 71335-2890-01 Bryant 198.4 g — — FDA listed —
Urea Cream 40% 400 mg/g 71399-8456-01 Akron 28.35 g — — FDA listed —
Urea 40 Percent 400 mg/g 72162-1668-02 Bryant 198.4 g — — FDA listed —
Urea Cream 40 Percent 400 mg/g 72162-2203-04 Bryant 85 g — — FDA listed —
Urevia Plus 400 mg/g 85622-0603-04 Blue 1 jar — — FDA listed —
Urea 40 400 mg/g 87021-0603-04 Krewe 1 jar — — FDA listed —
Urea 400 mg/g 24470-0962-08 Cintex 226.8 g — — FDA listed —
Urea 400 mg/g 81542-0201-08 Bantry 226.8 g — — 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
Oct 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.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Urea 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.

  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII SA6A6V432S
    Dimethyl isosorbide is a clear liquid solvent derived from natural sugar sources. It helps dissolve active ingredients and improve their absorption in liquid medicines and topical products.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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.
  • 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.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

10 inactive ingredients 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

LabelerPatrin Pharma, Inc
Labeler code39328
First marketedOct 2025
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Patrin Pharma, Inc labeler code 39328

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 ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

INDICATIONS For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

⏱️ Dosage and Administration 36 words ▾

DOSAGE AND ADMINISTRATION Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

⛔ Contraindications 20 words ▾

CONTRAINDICATIONS This product is contraindicated in people with known or suspected hypersensitivity to any of the ingredients of the product.

⚠️ Warnings 7 words ▾

WARNING KEEP OUT OF REACH OF CHILDREN.

🤒 Adverse Reactions 21 words ▾

ADVERSE REACTIONS Transient stinging, burning, itching or irritation may occur and will normally disappear upon discontinuing the use of this product.

🤰 Pregnancy 58 words ▾

Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

🧬 Clinical Pharmacology 44 words ▾

CLINICAL PHARMACOLOGY Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin. Pharmacokinetics The mechanism of action of topically applied urea is not yet known.

📦 How Supplied / Storage and Handling 23 words ▾

HOW SUPPLIED 28.35 g (1 oz.) bottles, NDC 39328-019-01 85 g (3 oz.) bottles, NDC 39328-019-03 198.4 g (7 oz.) bottles, NDC 39328-019-07

📦 Storage and Handling 20 words ▾

STORAGE Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed

📋 Description 44 words ▾

DESCRIPTION Each gram contains 400 mg of urea in a vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum. Urea is a diamide of carbonic acid with the chemical structure: Chemical Structure

💬 Information for Patients 36 words ▾

Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

⚠️ Precautions 207 words ▾

PRECAUTIONS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed.

If redness or irritation occurs, discontinue use and consult a physician. Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed. Pregnancy Category C Animal reproduction studies have not been conducted with this product.

It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

🧬 Pharmacokinetics 13 words ▾

Pharmacokinetics The mechanism of action of topically applied urea is not yet known.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 29 words ▾

Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed.

📄 Package Label / Principal Display Panel 34 words ▾

PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton NDC 39328-019-01 Urea 40% Topical Cream For External Use Only Not for Ophthalmic Use Rx Only Net Wt. 28.35 g (1 oz.) PATRIN PHARMA Chemical Structure

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 Urea (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Urea. 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
$1.1K
Claims incl. refills
98
Beneficiaries
88
Spend / beneficiary
$12.87
Spend / claim
$11.56
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 Urea 40% (this brand).

Top reported reactions

Diarrhoea187
Fatigue180
Nausea156
Decreased Appetite107
Rash105
Dyspnoea100
Vomiting100

Reporter sex

0 reports

Serious outcomes

Death212
Disabling52
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 270 82
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

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.

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) ✓ Available
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.
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 Patrin Pharma, Inc. 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 2 other package presentations of this same product, including 85 g (39328-0019-03), 198.4 g (39328-0019-07). 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?
Patrin Pharma, Inc 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.
← 38779-3399-05 · Medisca 39328-0020-08 · Patrin →
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.