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Vistogard uridine triacetate 951 mg/g Granule — NDC 50633-0220-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vistogard uridine triacetate 951 mg/g Granule — NDC 50633-220-04 (Billing 50633-0220-04)

by BTG International Inc · 4 PACKET in 1 CARTON / 10 g in 1 PACKET

This is a package of Vistogard uridine triacetate 951 mg/g Granule from BTG International Inc, marketed since Jul 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 50633-0220-04
🏷️ FDA NDC (as labeled) 50633-220-04 billing pads the product segment with a zero
This package
Contains10 g in 1 packet Pack sizes2 compare ↓
Main listing for product 50633-220 · Also comes in: 20 packets 50633-220-20
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 50633-220-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50633 labeler · 220 product · 04 package
Package marketed since
Jul 31, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0350633220109
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50633-220-04
Product NDC 50633-220
11-digit billing NDC 50633022004
NCPDP billing unit EA — each (per item)
RxCUI 1739794, 1739800
UNII 2WP61F175M
UPC 0350633220109
Application # NDA208159
SPL Set ID 269f7363-63ed-444e-85f1-f0009e44818b
Established class (EPC) Pyrimidine Analog
Chemical class Analogs/Derivatives; Pyrimidines
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-31
Route ORAL
Dosage form GRANULE
Substance URIDINE TRIACETATE

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

GPI-14 93000084203040
GCN Seq No 075268
GCN 40296
HICL code 042514
Ingredient (HICL) Uridine Triacetate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1I
Therapeutic class — specific (HIC3) Chemotherapy Rescue/Antidote Agents
AHFS code 91:04.32.00
AHFS class Fluoropyrimidine Antidote
FDB label name VISTOGARD 10 GRAM PACKET
FDB brand name Vistogard
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 075268
  • GCN: 40296
  • GPI-14 (Medi-Span): 93000084203040
  • HICL (First Databank): 042514
  • AHFS class code: 91:04.32.00
  • RxCUI (RxNorm): 1739794
Why two NDCs? The FDA registers this code as 50633-220-04 — 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 → 50633-0220-04. 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 Various alimentary tract and metabolism products class.

Drug family (ATC) Various alimentary tract and metabolism products
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 VISTOGARD 10 GRAM PACKET Ingredient Uridine Triacetate
📖 What it is MedlinePlus · NLM

Uridine triacetate is used for the emergency treatment of children and adults who have either received too much of chemotherapy medications such as fluorouracil or capecitabine (Xeloda) or who develop certain severe or life-threatening toxicities within 4 days of receiving fluorouracil or capecitabine. Uridine triacetate is in a class of medications called pyrimidine analogs. It works by blocking cell damage from certain chemotherapy medications.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Vistogard is an emergency treatment after an overdose of fluorouracil or capecitabine, or for severe early toxicity from them. Xuriden treats hereditary...
  • Both come as granules that you mix with soft food like applesauce, pudding or yogurt. Don't chew the granules, and drink at least 4 ounces of water after. Vistogard is taken every...
  • If you vomit within 2 hours of a dose, you need a full replacement dose as soon as possible. If you miss a dose, take it as soon as you can, then go back to your normal schedule.
  • What if I vomit or miss a dose of Vistogard?
📖 Read our full Uridine Triacetate guide →
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 · 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.
Try another pack size: 20 packets
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
50633-0220-04 You're viewing this Main listing 4 PACKET in 1 CARTON / 10 g in 1 PACKET 2024-07-31 — Active
50633-0220-20 50633-220-20 20 PACKET in 1 CARTON / 10 g in 1 PACKET 2024-07-31 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 packet in 1 carton / 10 g in 1 packet.
What NDC number is used to bill for this package of Vistogard uridine triacetate 951 mg/g Granule?
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
Vistogard 951 mg/gthis 50633-0220-04 BTG 4 packets — — FDA listed —
Xuriden 951 mg/g 50633-0330-30 BTG 30 packets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2015
First FDA approval
Dec 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2027
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2027. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 11, 2015 RLD RS ⏳ ~0.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

When could a generic Vistogard arrive?

Our estimate: August 2027 about 10 months away

How sure: Toss-up. Still unsettled. Just as likely to slip as to hold.

Why then: A patent that protects the brand runs out. After that, approved generics can be sold.

See the full forecast for generic Vistogard →
Patents & exclusivity — FDA Orange Book
US 7776838 — method of use (U-1791)
2015 2017 2019 2021 2023 2025 2027
Today
LOE
Expected generic
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 7776838 ↗ Method of use U-1791 Aug 17, 2027
Common questions
Is there a generic version of VISTOGARD 10 GRAM PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VISTOGARD 10 GRAM PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2027 — an estimate, not a guaranteed launch date. We expect the first generic Vistogard in August 2027, about 10 months away. See the forecast.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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
FlavorOrange
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 Uridine Triacetate 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 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 5A9KE2L9L3
    A citrus fruit liquid used as a flavoring and vehicle in oral medicines. It adds natural taste, helps mask bitter drug flavors, and provides liquid volume for dissolving or suspending active ingredients.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

4 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

LabelerBTG International Inc
Application holderBTG INTERNATIONAL INC
FDA applicationNDA208159 (NDA)
Labeler code50633
First marketedJul 2024
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from BTG International Inc labeler code 50633

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE VISTOGARD ® is indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. VISTOGARD ® is a pyrimidine analog indicated for the emergency treatment of adult and pediatric patients: following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

( 1 ) Limitations of use: VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. ( 1 ) The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. ( 1 ) Limitations of Use VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs.

The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage Adults : 10 grams (1 packet) orally every 6 hours for 20 doses, without regard to meals. ( 2.1 ) Pediatric : 6.2 grams/m 2 of body surface area (not to exceed 10 grams per dose) orally every 6 hours for 20 doses, without regard to meals. See the full prescribing information for body surface area-based dosing.

( 2.1 ) Preparation and Administration Pediatric : Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon accurate to ¼ teaspoon. ( 2.1 ) Mix each VISTOGARD dose with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt and ingest within 30 minutes of mixing. Do not chew the VISTOGARD granules.

Drink at least 4 ounces of water. ( 2.2 ) If a patient vomits within 2 hours of taking a dose of VISTOGARD, initiate another complete dose as soon as possible after the vomiting episode. Administer the next dose at the regularly scheduled time.

( 2.2 ) If a patient misses a dose at the scheduled time, administer that dose of VISTOGARD as soon as possible. Administer the next dose at the regularly scheduled time. ( 2.2 ) Administer VISTOGARD via a nasogastric tube (NG tube) or gastrostomy tube (G-Tube) when necessary (e.g., severe mucositis or coma).

( 2.2 )

2.1Recommended Dosage Adults: 10 grams (1 packet) orally every 6 hours for 20 doses, without regard to meals. Pediatric: 6.2 grams/m 2 of body surface area (not to exceed 10 grams per dose) orally every 6 hours for 20 doses, without regard to meals. The VISTOGARD dose to be administered at 6.2 grams/m 2 is presented in Table 1.

Measure the dose using either a scale accurate to at least 0.1 gram, or a graduated teaspoon accurate to ¼ teaspoon. Discard any unused portion of granules. Do not use granules left in the open packet for subsequent dosing.

Table 1 VISTOGARD Pediatric Dose Based on Body Surface Area (m 2 ) Patient Body Surface Area (m 2 ) Table 1 VISTOGARD 6.2 grams/m 2 /dose Dose by body surface area category in this table was rounded to achieve the approximate dose. Each dose is administered every 6 hours for 20 doses. Dose in Grams Dose in Graduated Teaspoons 0.34 to 0.44 2.1 to 2.7 1 0.45 to 0.55 2.8 to 3.4 1 ¼ 0.56 to 0.66 3.5 to 4.1 1 ½ 0.67 to 0.77 4.2 to 4.8 1 ¾ 0.78 to 0.88 4.9 to 5.4 2 0.89 to 0.99 5.5 to 6.1 2 ¼ 1.00 to 1.10 6.2 to 6.8 2 ½ 1.11 to 1.21 6.9 to 7.5 2 ¾ 1.22 to 1.32 7.6 to 8.1 3 1.33 to 1.43 8.2 to 8.8 3 ¼ 1.44 and above May use 1 entire 10 g packet without weighing or measuring.

Do not exceed 10 grams/dose. 10.0 1 full packet Administer VISTOGARD as soon as possible after an overdose or early-onset toxicity within 96 hours following the end of fluorouracil or capecitabine administration. Administer full course of VISTOGARD (20 doses) as directed.

2.2Preparation and Administration Mix each VISTOGARD dose with 3 to 4 ounces of soft foods such as applesauce, pudding or yogurt and ingest within 30 minutes. Do not chew the VISTOGARD granules. Drink at least 4 ounces of water.

If a patient vomits within 2 hours of taking a dose of VISTOGARD, initiate another complete dose as soon as possible after the vomiting episode. Administer the next dose at the regularly scheduled time. If a patient misses a dose at the scheduled time, administer that dose of VISTOGARD as soon as possible.

Administer the next dose at the regularly scheduled time. Administer VISTOGARD via a nasogastric tube (NG tube) or gastrostomy tube (G-Tube) when necessary (eg, severe mucositis or coma). Follow the instructions below for each dose administration: Prepare approximately 4 fluid ounces (about 100 mL) of a food starch-based thickening product in water and stir briskly until the thickener has dissolved.

Crush the contents of one full 10 gram packet of VISTOGARD granules to a fine powder. Add the crushed VISTOGARD granules to 4 ounces (about 100 mL) of the reconstituted food starch-based thickening product. For pediatric patients receiving less than 10 grams, prepare the mixture at a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral granules: 10 grams of orange-flavored, white-to-off-white, oral granules (95% w/w) in single-dose packets. Oral granules: 10 gram packets ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 9 words ▾

5 WARNINGS AND PRECAUTIONS None. None. ( 5 )

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS Adverse reactions occurring in >2% of patients receiving VISTOGARD included vomiting, nausea, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG International Inc at (1-877-377-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and using a wide range of doses, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VISTOGARD was assessed in 135 patients (median age 59 years, 56% male) treated in 2 single-arm, open-label, multi-center trials. VISTOGARD was administered at 10 grams orally every 6 hours for 20 doses or at a body surface area adjusted dosage of 6.2 grams/m 2 /dose for 20 doses in four patients between 1 and 7 years of age.

The median duration of exposure was 4.8 days, with a median of 20 doses (range 1 to 23). VISTOGARD was discontinued for adverse reactions in two (1.4%) patients. Serious adverse reactions and Grade ≥3 adverse reactions were seen in one patient receiving VISTOGARD (Grade 3 nausea and vomiting).

Table 2 summarizes the adverse reactions that occurred in greater than 2% of patients in Studies 1 and 2 combined. Table 2 Adverse Reactions in > 2% of Patients Receiving VISTOGARD in Studies 1 and 2 Adverse Reaction N=135 Patients Vomiting 13 (10%) Nausea 7 (5%) Diarrhea 4 (3%)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Limited case reports of uridine triacetate use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. When administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses of one-half the maximum recommended human dose (MRHD) of 40 grams per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see Data ] . The background risk of major birth defects and miscarriage for the indicated population are unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about one-half the maximum recommended human dose (MRHD) of 40 grams per day on a body surface area basis). There was no evidence of teratogenicity or harm to the fetus and no effect on maternal body weight and overall health.

8.2Lactation Risk Summary There are no data on the presence of uridine triacetate in human milk, the effect on the breastfed infant or the effect on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for VISTOGARD and any potential adverse effects on the breastfed infant from VISTOGARD or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of VISTOGARD have been established in pediatric patients. Use of VISTOGARD in pediatric patients is supported by an open-label clinical study of adults (Study 1) and a second open-label clinical study which included 6 pediatric patients ranging in age from 1 to 16 years (Study 2). Four of these pediatric patients were between 1 to 7 years of age and received a body-surface area adjusted dosage of 6.2 grams/m 2 /dose for 20 doses.

The clinical response and safety in adult and pediatric patients treated with VISTOGARD were similar; however, clinical data are limited [see Clinical Studies (14) ].

8.5Geriatric Use Of the 135 patients in clinical studies with VISTOGARD, 30% were 65 and over, including 11% that were 75 and over. Clinical studies of VISTOGARD did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🤰 Pregnancy 181 words ▾

8.1Pregnancy Risk Summary Limited case reports of uridine triacetate use during pregnancy are insufficient to inform a drug-associated risk of birth defects and miscarriage. When administered orally to pregnant rats during the period of organogenesis, uridine triacetate at doses of one-half the maximum recommended human dose (MRHD) of 40 grams per day was not teratogenic and did not produce adverse effects on embryo-fetal development [see Data ] . The background risk of major birth defects and miscarriage for the indicated population are unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, uridine triacetate was administered orally to pregnant rats during the period of organogenesis at doses up to 2000 mg/kg per day (about one-half the maximum recommended human dose (MRHD) of 40 grams per day on a body surface area basis). There was no evidence of teratogenicity or harm to the fetus and no effect on maternal body weight and overall health.

🧒 Pediatric Use 106 words ▾

8.4Pediatric Use The safety and effectiveness of VISTOGARD have been established in pediatric patients. Use of VISTOGARD in pediatric patients is supported by an open-label clinical study of adults (Study 1) and a second open-label clinical study which included 6 pediatric patients ranging in age from 1 to 16 years (Study 2). Four of these pediatric patients were between 1 to 7 years of age and received a body-surface area adjusted dosage of 6.2 grams/m 2 /dose for 20 doses.

The clinical response and safety in adult and pediatric patients treated with VISTOGARD were similar; however, clinical data are limited [see Clinical Studies (14) ].

🧓 Geriatric Use 48 words ▾

8.5Geriatric Use Of the 135 patients in clinical studies with VISTOGARD, 30% were 65 and over, including 11% that were 75 and over. Clinical studies of VISTOGARD did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Uridine triacetate is an acetylated pro-drug of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation. Uridine competitively inhibits cell damage and cell death caused by fluorouracil.

Fluorouracil is a cytotoxic antimetabolite that interferes with nucleic acid metabolism in normal and cancer cells. Cells anabolize fluorouracil to the cytotoxic intermediates 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). FdUMP inhibits thymidylate synthase, blocking thymidine synthesis.

Thymidine is required for DNA replication and repair. Uridine is not found in DNA. The second source of fluorouracil cytotoxicity is the incorporation of its metabolite, FUTP, into RNA.

This incorporation of FUTP into RNA is proportional to systemic fluorouracil exposure. Excess circulating uridine derived from VISTOGARD is converted into uridine triphosphate (UTP), which competes with FUTP for incorporation into RNA.

12.3Pharmacokinetics Absorption VISTOGARD delivers 4- to 6-fold more uridine into the systemic circulation compared to equimolar doses of uridine itself. Maximum concentrations of uridine in plasma following oral VISTOGARD are generally achieved within 2 to 3 hours, and the half-life ranges from approximately 2 to 2.5 hours. Studies 1 and 2 included an assessment of plasma uridine in a subgroup of patients who were overdosed with fluorouracil or experiencing early-onset of serious fluorouracil toxicities.

Samples were obtained prior to VISTOGARD treatment and at 1 to 4 hours following the first and final doses of VISTOGARD given at 10 g (adults) or 6.2 grams/m 2 (pediatric) every 6 hours for up to 20 doses. Plasma uridine concentrations are summarized in Table 3. Table 3 Plasma Uridine Concentrations (µM) in Studies 1 and 2 Study Predose Post First Dose Post Final Dose Study 1 Values shown are mean (standard deviation) for plasma uridine (µM) 8 (33) 99 (64) 160 (81) N = 49 N = 49 N = 40 Study 2 5 (17) 119 (59) 153 (68) N = 27 N = 26 N = 24 Food Effect on Uridine PK: A study in healthy adult subjects receiving a slightly different formulation of uridine triacetate granules (6 gram dose) under fed and fasted conditions showed no difference in the overall rate and extent of uridine exposure.

Distribution Circulating uridine is taken up into mammalian cells via specific nucleoside transporters, and also crosses the blood brain barrier. Excretion Uridine can be excreted via the kidneys, but is also metabolized by normal pyrimidine catabolic pathways present in most tissues. Drug Interaction Studies In vitro enzyme inhibition data did not reveal meaningful inhibitory effects of uridine triacetate or uridine on CYP3A4, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.

In vitro enzyme induction data did not reveal an inducing effect of uridine triacetate or uridine on CYP1A2, CYP2B6, or CYP3A4. In vitro data showed that uridine triacetate was a weak substrate for P-glycoprotein. Uridine triacetate inhibited the transport of a known P-glycoprotein substrate, digoxin, with an IC50 of 344 µM.

Due to the potential for high local (gut) concentrations of the drug after dosing, the interaction of VISTOGARD with orally administered P-gp substrate drugs cannot be ruled out. In vivo data in humans are not available. Specific Populations Sex Pharmacokinetics analyses showed that sex did not have a significant effect on uridine pharmacokinetics.

Age Pharmacokinetic analysis showed that within the age range evaluated (20 to 83 years), age did not have a significant effect on uridine pharmacokinetics. Body Size Pharmacokinetic analyses showed no clinically meaningful effect of body surface area on uridine PK in adults.

🧬 Mechanism of Action 139 words ▾

12.1Mechanism of Action Uridine triacetate is an acetylated pro-drug of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the circulation. Uridine competitively inhibits cell damage and cell death caused by fluorouracil.

Fluorouracil is a cytotoxic antimetabolite that interferes with nucleic acid metabolism in normal and cancer cells. Cells anabolize fluorouracil to the cytotoxic intermediates 5-fluoro-2'-deoxyuridine-5'-monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). FdUMP inhibits thymidylate synthase, blocking thymidine synthesis.

Thymidine is required for DNA replication and repair. Uridine is not found in DNA. The second source of fluorouracil cytotoxicity is the incorporation of its metabolite, FUTP, into RNA.

This incorporation of FUTP into RNA is proportional to systemic fluorouracil exposure. Excess circulating uridine derived from VISTOGARD is converted into uridine triphosphate (UTP), which competes with FUTP for incorporation into RNA.

📦 How Supplied / Storage and Handling 68 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VISTOGARD orange-flavored oral granules (95% w/w) are available in single-dose packets containing 10 grams of uridine triacetate. NDC Number Package Configuration 50633-220-20 Course of therapy package: 1 carton containing 20 single-dose packets of VISTOGARD 50633-220-04 24-Hour Pack: 1 carton containing 4 single-dose packets of VISTOGARD Store at USP controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).

📦 Storage and Handling 18 words ▾

Store at USP controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).

📋 Description 96 words ▾

11 DESCRIPTION VISTOGARD oral granules contain the active ingredient uridine triacetate which is a pyrimidine analog. The chemical name for uridine triacetate is (2',3',5'-tri-O-acetyl-β-D-ribofuranosyl)-2,4(1H,3H)-pyrimidinedione. The molecular weight is 370.3 grams/mole and it has an empirical formula of C 15 H 18 N 2 O 9 .

The structural formula is: Each single-dose 10 gram packet of VISTOGARD orange-flavored oral granules (95% w/w) contains 10 grams of uridine triacetate and the following inactive ingredients: ethylcellulose (0.309 grams), Opadry ® Clear [proprietary dispersion of hydroxypropylmethylcellulose and Macrogol] (0.077 grams), and natural orange juice flavor (0.131 grams). Chemical Structure

💬 Information for Patients 129 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information) Dosing Instructions [see Dosage and Administration (2.1) and (2.2) ] Advise the patient or caregiver: The importance of taking all 20 doses, even if they feel well. That VISTOGARD can be taken mixed in food (applesauce, pudding or yogurt). That the VISTOGARD granules should not be chewed.

That if the patient vomits within 2 hours of taking a dose of VISTOGARD to take another complete dose as soon as possible after vomiting. Take the next dose at the regularly scheduled time. That if the patient misses a dose at the scheduled time, to take that dose of VISTOGARD as soon as possible.

Then take the next dose at the regularly scheduled time.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption VISTOGARD delivers 4- to 6-fold more uridine into the systemic circulation compared to equimolar doses of uridine itself. Maximum concentrations of uridine in plasma following oral VISTOGARD are generally achieved within 2 to 3 hours, and the half-life ranges from approximately 2 to 2.5 hours. Studies 1 and 2 included an assessment of plasma uridine in a subgroup of patients who were overdosed with fluorouracil or experiencing early-onset of serious fluorouracil toxicities.

Samples were obtained prior to VISTOGARD treatment and at 1 to 4 hours following the first and final doses of VISTOGARD given at 10 g (adults) or 6.2 grams/m 2 (pediatric) every 6 hours for up to 20 doses. Plasma uridine concentrations are summarized in Table 3. Table 3 Plasma Uridine Concentrations (µM) in Studies 1 and 2 Study Predose Post First Dose Post Final Dose Study 1 Values shown are mean (standard deviation) for plasma uridine (µM) 8 (33) 99 (64) 160 (81) N = 49 N = 49 N = 40 Study 2 5 (17) 119 (59) 153 (68) N = 27 N = 26 N = 24 Food Effect on Uridine PK: A study in healthy adult subjects receiving a slightly different formulation of uridine triacetate granules (6 gram dose) under fed and fasted conditions showed no difference in the overall rate and extent of uridine exposure.

Distribution Circulating uridine is taken up into mammalian cells via specific nucleoside transporters, and also crosses the blood brain barrier. Excretion Uridine can be excreted via the kidneys, but is also metabolized by normal pyrimidine catabolic pathways present in most tissues. Drug Interaction Studies In vitro enzyme inhibition data did not reveal meaningful inhibitory effects of uridine triacetate or uridine on CYP3A4, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.

In vitro enzyme induction data did not reveal an inducing effect of uridine triacetate or uridine on CYP1A2, CYP2B6, or CYP3A4. In vitro data showed that uridine triacetate was a weak substrate for P-glycoprotein. Uridine triacetate inhibited the transport of a known P-glycoprotein substrate, digoxin, with an IC50 of 344 µM.

Due to the potential for high local (gut) concentrations of the drug after dosing, the interaction of VISTOGARD with orally administered P-gp substrate drugs cannot be ruled out. In vivo data in humans are not available. Specific Populations Sex Pharmacokinetics analyses showed that sex did not have a significant effect on uridine pharmacokinetics.

Age Pharmacokinetic analysis showed that within the age range evaluated (20 to 83 years), age did not have a significant effect on uridine pharmacokinetics. Body Size Pharmacokinetic analyses showed no clinically meaningful effect of body surface area on uridine PK in adults.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of VISTOGARD was assessed in 135 patients who were treated in two open-label trials, Study 1 (n=60) and Study 2 (n=75). The patients in both studies had either received an overdose of fluorouracil or capecitabine, or presented with severe or life-threatening toxicities within 96 hours following the end of fluorouracil or capecitabine administration. Overdose was defined as administration of fluorouracil at a dose, or infusion rate, greater than the intended dose or maximum tolerated dose for the patient's intended regimen of fluorouracil.

VISTOGARD was administered at 10 grams orally every 6 hours for 20 doses or at a body surface area adjusted dosage of 6.2 grams/m 2 /dose for 20 doses for four patients between 1 and 7 years of age. The major efficacy outcome was survival at 30 days or until the resumption of chemotherapy if prior to 30 days. In Study 1 and Study 2 combined, the median age of the patients was 59 years (range: 1 to 83), 56% were male, 72% were white, 9% were Black/African American, 6% were Hispanic, 4% were Asian, and 95% had a cancer diagnosis.

Of the 135 patients, 117 were treated with VISTOGARD following an overdose of fluorouracil (n=112) or capecitabine (n=5), and 18 were treated after exhibiting severe or life-threatening fluorouracil toxicities within 96 hours following the end of fluorouracil administration. The severe or life-threatening toxicities involved the central nervous system (such as encephalopathy, acute mental status change), cardiovascular system, gastrointestinal system (such as mucositis), and bone marrow. A total of six pediatric patients were administered VISTOGARD.

Four patients initiated VISTOGARD more than 96 hours following the end of fluorouracil or capecitabine administration. Of the 112 patients overdosed with fluorouracil, 105 (94%) were overdosed by infusion rate only (range 1.3 to 720 times the planned infusion rate), four (4%) were overdosed by dose only, and three (3%) were overdosed by both dose and rate. The survival results are shown in Table 4.

Of the 135 patients who were treated with VISTOGARD in Studies 1 and 2 there were five deaths due to fluorouracil or capecitabine toxicity (4%). Of the five patients who died, two were treated after 96 hours following the end of fluorouracil administration. In the patients treated with VISTOGARD for an overdose of fluorouracil or capecitabine in Studies 1 and 2 combined (n=117), survival at 30 days was 97% (n=114).

In the patients receiving VISTOGARD for early-onset severe or life-threatening toxicity in Studies 1 and 2 combined (n=18), the survival at 30 days was 89% (n=16). In these studies 33% of patients (n=45) resumed chemotherapy in less than 30 days. Based on retrospective historical case reports of 25 patients who were overdosed with fluorouracil and received supportive care only, all were overdosed by rate with a range 1.9 to 64 times the planned infusion rate, and 84% died.

Table 4 Combined Efficacy: All Patients in Study 1 and Study 2 Overdose Early-Onset Overall Total Enrolled 117 18 135 Survival Survival includes patients who survived at 30 days or patients who resumed chemotherapy prior to 30 days. 114 (97%) 16 (89%) 130 (96%) Death 3 (3%) 2 (11%) 5 (4%)

🧪 Nonclinical Toxicology 185 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of uridine triacetate. Uridine triacetate was not genotoxic in the Ames test, the mouse lymphoma assay and the mouse micronucleus test. Orally administered uridine triacetate did not affect fertility or general reproductive performance in male and female rats at doses up to 2000 mg/kg per day (about one-half the maximum recommend human dose (MRHD) of 40 grams per day on a body surface area basis).

13.2Animal Toxicology and/or Pharmacology In mice given a sub-lethal dose of fluorouracil, the administration of oral uridine triacetate diminished hematological toxicity as a function of increasing dose, but did not completely prevent hematological toxicity. In mice given a lethal dose of fluorouracil, administration of oral uridine triacetate increased survival to 90% when given within 24 hours. Survival diminished with increasing interval between the fluorouracil dose and uridine triacetate treatment demonstrating that earlier administration of uridine triacetate is more beneficial.

In similar experiments in mice, uridine triacetate treatment diminished damage to the intestinal mucosa caused by fluorouracil treatment.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 84 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of uridine triacetate. Uridine triacetate was not genotoxic in the Ames test, the mouse lymphoma assay and the mouse micronucleus test. Orally administered uridine triacetate did not affect fertility or general reproductive performance in male and female rats at doses up to 2000 mg/kg per day (about one-half the maximum recommend human dose (MRHD) of 40 grams per day on a body surface area basis).

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 10/2023 Patient Information VISTOGARD (VIS-toe-gard) (uridine triacetate) oral granules What is VISTOGARD? VISTOGARD is a prescription medicine that contains uridine, a substance that is normally found in your body.

VISTOGARD is used for emergency treatment of adults and children: after an overdose of fluorouracil or capecitabine with or without symptoms, or who have early signs of severe or life-threatening side effects that affect the heart, or early signs of severe or life threatening neurologic (central nervous system) problems, or certain unusually severe side effects within 4 days (96 hours) after receiving treatment with fluorouracil or capecitabine VISTOGARD should only be used for the emergency treatment of side effects of fluorouracil or capecitabine, because it may decrease the effectiveness of these medicines.

It is not known if VISTOGARD is safe and effective if started more than 4 days (96 hours) after the end of a dose of fluorouracil or capecitabine. Before taking VISTOGARD, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if VISTOGARD will harm your unborn baby. are breastfeeding or plan to breastfeed.

It is not known if VISTOGARD passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VISTOGARD. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VISTOGARD? Take VISTOGARD exactly as prescribed by your healthcare provider. It is important that you take all 20 doses of VISTOGARD even if you feel well.

VISTOGARD comes in single-dose packets that contain 10 grams of orange-flavored granules. If your healthcare provider decides that you can give VISTOGARD to your child at home, it is important that you follow your healthcare provider's instructions. Your healthcare provider will prescribe VISTOGARD to your child based on your child's weight.

The usual adult dose of VISTOGARD is 1 packet taken by mouth every 6 hours for a total of 20 doses. If you vomit within 2 hours of taking a dose of VISTOGARD, take another full dose as soon as possible. Then take your next VISTOGARD dose at your next regularly scheduled time.

If you miss a dose of VISTOGARD at the scheduled time, take the missed dose as soon as possible. Then take the next dose at the regularly scheduled time. Preparing and taking a dose of VISTOGARD: Mix each packet of VISTOGARD granules with 3 to 4 ounces of soft food such as applesauce, pudding or yogurt in a small container.

Take all of the VISTOGARD granules mixed with food within 30 minutes of mixing. Do not chew the VISTOGARD granules. Drink at least 4 ounces of water to make sure that you swallow all of the medicine.

What are the possible side effects of VISTOGARD? Common side effects of VISTOGARD include: vomiting, nausea, and diarrhea. These are not all the possible side effects of VISTOGARD.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store VISTOGARD?

Store VISTOGARD at room temperature between 68°F to 77°F (20°C to 25°C) Keep VISTOGARD and all medicines out of the reach of children. General information about the safe and effective use of VISTOGARD. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use VISTOGARD for a condition for which it was not prescribed. Do not give VISTOGARD to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about VISTOGARD that is written for health professionals. What are the ingredients of VISTOGARD? Active Ingredient: uridine triacetate Inactive Ingredients: ethylcellulose, Opadry… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 113 words ▾

PRINCIPAL DISPLAY PANEL - 20 Count - 10 g Packet Carton NDC 50633-220-20 Rx Only VISTOGARD ® 10 g (uridine triacetate) oral granules Carton contains 20 x 10 gram packets BTG Pharmaceuticals PRINCIPAL DISPLAY PANEL - 10 g Packet Carton

PRINCIPAL DISPLAY PANEL - 4 Count 10 g Packet Carton NDC 50633-220-04 Rx Only VISTOGARD ® 10 g (uridine triacetate) oral granules Carton contains 4 x 10 gram packets BTG Pharmaceuticals PRINCIPAL DISPLAY PANEL - 10 g Packet Carton

PRINCIPAL DISPLAY PANEL - 10 g Single Dose Sachet Foil NDC 50633-220-10 Rx Only VISTOGARD ® 10 g (uridine triacetate) oral granules Single-Dose Packets BTG Pharmaceuticals PRINCIPAL DISPLAY PANEL - 10 g Sachet Foil

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

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 VISTOGARD (this brand).

Top reported reactions

Complication Associated With Device21
Vomiting21
Diarrhoea20
Thrombocytopenia13
Mucosal Inflammation12
Nausea12
Death10

Age at onset

Elderly1

Reporter sex

115 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization27
Death26
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 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
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 BTG International 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 1 other package presentation of this same product, including 20 packets (50633-0220-20). 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?
BTG International 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.
← 50633-0210-11 · BTG 50633-0230-01 · BTG →
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.