HomeNDC LookupIngredientsSucralfate › 72578-0081-05
Sucralfate 1 g Tablet, 500-count — NDC 72578-0081-05 package photo

Sucralfate 1 g Tablet, 500-count

by Viona Pharmaceuticals Inc · 500 TABLET in 1 BOTTLE (72578-081-05)
NDC 72578-0081-05
🏷️ FDA NDC (as labeled) 72578-081-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.1725 NADAC Per package$86.25 / 500 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2473/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 72578-081-05
Product NDC 72578-081
11-digit billing NDC 72578008105
NCPDP billing unit EA — each (per item)
RxCUI 314234
UNII XX73205DH5
Application # ANDA215705
SPL Set ID c708201b-2618-4470-a3ff-8ecf04d6b3a0
Established class (EPC) Aluminum Complex
Chemical class Organometallic Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-20
Route ORAL
Dosage form TABLET
Substance SUCRALFATE
GCN Seq No 002766
GCN 08200
HICL code 001186
Ingredient (HICL) Sucralfate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4E
Therapeutic class — specific (HIC3) Anti-Ulcer Preparations
AHFS code 56:28.32.00
AHFS class Protectants
FDB label name SUCRALFATE 1 GM TABLET
FDB brand name Sucralfate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72578-081-05 — 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 → 72578-0081-05. 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 Aluminum Complex class.

Pharmacologic class Aluminum Complex
Drug family (ATC) Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
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.

🏭 Manufacturer & labeler

LabelerViona Pharmaceuticals Inc
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA215705 (ANDA)
Labeler code72578
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio94 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.

🩺 Clinical

Label name SUCRALFATE 1 GM TABLET Ingredient Sucralfate
📗 Our plain-language guide HelloPharmacist
  • Sucralfate helps heal a duodenal ulcer — that's an ulcer in the first part of your small intestine. It works by coating the ulcer like a protective bandage, shielding it from stoma...
  • What exactly is sucralfate supposed to do for me?
  • Yes, timing really does matter. You should take sucralfate on an empty stomach so it can stick directly to the ulcer lining. Taking it with food can get in the way of that. If you...
  • When should I take sucralfate — does it matter if I take it with food?
📖 Read our full Sucralfate guide →
1
Nutrient depletion considerations

Sucralfate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color White
ShapeCapsule
Imprint675
Size2 mm
ScoringScored — splits in 2
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.

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

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

3 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 DailyMedingredient 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.173 $86.25 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.2473 $123.65 / 500 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.224 $0.173
▼ Down 22% over the last 12 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sucralfate 1 g 00093-2210-01 Teva 100 tablets $0.172 AB Availability likely
Sucralfate 1 g 51079-0753-20 Mylan 100 tablets $0.172 AB Availability likely
Sucralfate 1 g 59762-0401-01 Mylan 100 tablets $0.172 AB Availability likely
Sucralfate 1 g 60219-1656-01 Amneal 100 tablets $0.172 AB Availability likely
Sucralfate 1 g 62135-0436-90 Chartwell 90 tablets $0.172 AB Availability likely
Sucralfate 1 g 69238-1656-01 Amneal 100 tablets $0.172 AB Availability likely
Sucralfate 1 gthis 72578-0081-05 Viona 500 tablets $0.172 AB Availability likely
Sucralfate 1 g 60687-0695-01 American 100 tablets $0.179 AB Discontinued +4%
Carafate 1 g 58914-0171-10 Allergan, 100 tablets $4.733 AB Availability likely +2644%
Sucralfate 1 g 00615-4517-30 NCS 30 tablets AB Discontinued
Sucralfate 1 g 00615-8653-39 NCS 30 tablets AB FDA listed
Sucralfate 1 g 42291-0936-90 AvKARE 90 tablets AB FDA listed
Sucralfate 1 g 48433-0091-20 Safecor 100 tablets AB FDA listed
Sucralfate 1 g 50090-5287-00 A-S 60 tablets AB FDA listed
Sucralfate 1 g 50090-6455-00 A-S 60 tablets AB FDA listed
Sucralfate 1 g 51407-0881-90 Golden 90 tablets AB FDA listed
Sucralfate 1 g 51655-0031-52 Northwind 30 tablets AB FDA listed
Sucralfate 1 g 51655-0475-52 Northwind 30 tablets AB FDA listed
Sucralfate 1 g 55154-4379-00 Cardinal 10 tablets AB FDA listed
Sucralfate 1 g 63629-1307-00 Bryant 28 tablets AB FDA listed
Sucralfate 1 g 63629-9152-01 Bryant 100 tablets AB FDA listed
Sucralfate 1 g 63629-9153-01 Bryant 500 tablets AB FDA listed
Sucralfate 1 g 67046-1469-03 Coupler 30 tablets AB FDA listed
Sucralfate 1 g 67296-2147-04 Redpharm 40 tablets AB FDA listed
Sucralfate 1 g 68071-1749-01 NuCare 100 tablets AB FDA listed
Sucralfate 1 g 68071-3478-03 NuCare 30 tablets AB FDA listed
Sucralfate 1 g 68071-3812-03 NuCare 30 tablets AB FDA listed
Sucralfate 1 g 68788-8316-01 Preferred 100 tablets AB FDA listed
Sucralfate 1 g 68788-8779-03 Preferred 30 tablets AB FDA listed
Sucralfate 1 g 68788-8946-01 Preferred 100 tablets AB FDA listed
Sucralfate 1 g 70771-1833-01 Zydus 100 tablets AB FDA listed
Sucralfate 1 g 71335-2114-00 Bryant 28 tablets AB FDA listed
Sucralfate 1 g 71335-2461-00 Bryant 28 tablets AB FDA listed
Sucralfate 1 g 71335-2637-00 Bryant 28 tablets AB FDA listed
Sucralfate 1 g 71610-0017-60 Aphena 90 tablets AB FDA listed
Sucralfate 1 g 71610-0541-60 Aphena 90 tablets AB FDA listed
Sucralfate 1 g 72162-2264-01 Bryant 100 tablets AB FDA listed
Sucralfate 1 g 72189-0234-20 DIRECT 20 tablets AB FDA listed
Sucralfate 1 g 72189-0429-20 Direct_Rx 20 tablets AB FDA listed
Sucralfate 1 g 80425-0091-01 Advanced 30 tablets AB FDA listed
Sucralfate 1 g 80425-0188-01 Advanced 30 tablets AB FDA listed
Sucralfate 1 g 80425-0213-01 Advanced 30 tablets AB FDA listed
Sucralfate 1 g 80425-0377-01 Advanced 30 tablets AB FDA listed
Sucralfate 1 g 82804-0063-30 Proficient 30 tablets AB FDA listed
Sucralfate 1 g 82804-0102-30 Proficient 30 tablets AB FDA listed
Sucralfate 1 g 87063-0176-01 ASCLEMED 100 tablets AB FDA listed
Sucralfate 1 g 55154-0281-00 Cardinal 10 tablets 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 years 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72578-0081-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
35.4K
Units reimbursed last 4 qtrs
3.2M
Gross reimbursed last 4 qtrs
$783.8K
Avg / prescription
$22.16
Avg / unit
$0.2473
Latest quarter Q4 2025
13KRx
Medicaid pays / ea
$0.2473
gross reimbursed
vs
NADAC / ea
$0.1725
acquisition cost
=
Spread
+$0.0748
+43% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
39% FFS 61% MCO
Fee-for-service · 13,697 Rx Managed care · 21,681 Rx
State Medicaid map
Alaska: 13,370 units · 1,824 per 100k residents AK Maine: 8,106 units · 581 per 100k residents ME Washington: 141,584 units · 1,812 per 100k residents WA Idaho: 36,996 units · 1,884 per 100k residents ID Montana: 36,974 units · 3,266 per 100k residents MT North Dakota: 4,901 units · 626 per 100k residents ND Minnesota: 43,878 units · 765 per 100k residents MN Wisconsin: 57,425 units · 972 per 100k residents WI Michigan: 160,981 units · 1,604 per 100k residents MI New York: 184,933 units · 945 per 100k residents NY Vermont: 1,278 units · 198 per 100k residents VT New Hampshire: 1,278 units · 91.2 per 100k residents NH Oregon: 148,514 units · 3,508 per 100k residents OR Nevada: 22,265 units · 697 per 100k residents NV Wyoming: 2,368 units · 405 per 100k residents WY South Dakota: 15,721 units · 1,711 per 100k residents SD Iowa: 41,694 units · 1,300 per 100k residents IA Illinois: 116,664 units · 930 per 100k residents IL Indiana: 69,709 units · 1,016 per 100k residents IN Ohio: 181,486 units · 1,540 per 100k residents OH Pennsylvania: 61,722 units · 476 per 100k residents PA New Jersey: 56,341 units · 606 per 100k residents NJ Massachusetts: 16,276 units · 232 per 100k residents MA California: 181,297 units · 465 per 100k residents CA Utah: 10,209 units · 299 per 100k residents UT Colorado: 57,737 units · 982 per 100k residents CO Nebraska: 21,408 units · 1,082 per 100k residents NE Missouri: 140,555 units · 2,268 per 100k residents MO Kentucky: 318,182 units · 7,030 per 100k residents KY West Virginia: 37,054 units · 2,093 per 100k residents WV Virginia: 61,635 units · 707 per 100k residents VA Maryland: 27,677 units · 448 per 100k residents MD Connecticut: 3,111 units · 86.0 per 100k residents CT Rhode Island: 4,032 units · 368 per 100k residents RI Arizona: 69,943 units · 941 per 100k residents AZ New Mexico: 47,242 units · 2,235 per 100k residents NM Kansas: 11,726 units · 399 per 100k residents KS Arkansas: 128,508 units · 4,190 per 100k residents AR Tennessee: 59,837 units · 840 per 100k residents TN North Carolina: 48,918 units · 451 per 100k residents NC South Carolina: 33,619 units · 626 per 100k residents SC Delaware: no data reported DE Oklahoma: 79,728 units · 1,967 per 100k residents OK Louisiana: 98,740 units · 2,159 per 100k residents LA Mississippi: 22,201 units · 755 per 100k residents MS Alabama: 87,742 units · 1,718 per 100k residents AL Georgia: 79,034 units · 717 per 100k residents GA D.C.: 568 units · 83.7 per 100k residents DC Hawaii: 2,652 units · 185 per 100k residents HI Texas: 75,370 units · 247 per 100k residents TX Florida: 8,827 units · 39.0 per 100k residents FL
Units reimbursed · per 100k residents
39.07,030
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 7,030 /100k
2 Arkansas 4,190 /100k
3 Oregon 3,508 /100k
4 Montana 3,266 /100k
5 Missouri 2,268 /100k
6 New Mexico 2,235 /100k
7 Louisiana 2,159 /100k
8 West Virginia 2,093 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets72578-0081-01 86,488 Rx · $1,820,040
500 tablets this page72578-0081-05 35,378 Rx · $783,835
30 tablets72578-0081-06 No Medicaid data
Drug total (last 4 qtrs): 121,866 Rx · 11,181,643 units · $2,603,875 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sucralfate — the program that covers self-administered drugs. 19 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 Sucralfate. 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
$26.89M
Claims incl. refills
567.6K
Beneficiaries
356.8K
Spend / beneficiary
$75.38
Spend / claim
$47.38
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 Sucralfate — the ingredient across all brands.

Top reported reactions

Nausea2,353
Fatigue1,798
Diarrhoea1,764
Pain1,520
Headache1,429
Vomiting1,411
Dyspnoea1,355

Age at onset

Neonate1
Infant7
Child45
Adolescent67
Adult2,001
Elderly1,712

Reporter sex

23,819 reports
Male · 32%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization9,249
Death2,309
Life-threatening765
Disabling525
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,059 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72578-0081-01 100 TABLET in 1 BOTTLE (72578-081-01) $0.1725 / ea $17.25 2023-05-20 Active
72578-0081-05 You're viewing this 500 TABLET in 1 BOTTLE (72578-081-05) $0.1725 / ea $86.24 2023-05-20 Active
72578-0081-06 30 TABLET in 1 BOTTLE (72578-081-06) 2023-05-20 Active

You're viewing the largest of 3 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1725 NADAC).

This pack accounts for about 29% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 72578-0081-05?
NDC 72578-0081-05 is a 500-count package — 500 tablet in 1 bottle.
What is the difference between NDC 72578-0081-05 and NDC 72578-0081-06?
Both are Sucralfate 1 g Tablet — the drug itself is identical. NDC 72578-0081-05 is the 500-count package, while NDC 72578-0081-06 is the 30 tablets package.
What NDC number is used to bill for this package of Sucralfate 1 g Tablet?
Bill NDC 72578-0081-05 — the 11-digit billing format is 72578008105. 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.

📄 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 63 words

INDICATIONS AND USAGE Sucralfate tablets are indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

⏱️ Dosage and Administration 163 words

DOSAGE AND ADMINISTRATION Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g four times per day on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Maintenance Therapy: The recommended adult oral dosage is 1 g twice a day. Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (See PRECAUTIONS Geriatric Use ).

Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications 21 words

CONTRAINDICATIONS Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

🤒 Adverse Reactions 197 words

ADVERSE REACTIONS Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 patients treated with sucralfate tablets, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%).

Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria. Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of sucralfate.

Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli.

Sucralfate is not intended for inteavenous administration.

🆘 Overdosage 84 words

OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract.

Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

🧬 Clinical Pharmacology 182 words

CLINICAL PHARMACOLOGY Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. Although the mechanism of sucralfate's ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action.

The following observations also appear pertinent: 1. Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site. 2.

In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. 3. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.

4. In vitro, sucralfate adsorbs bile salts. These observations suggest that sucralfate's antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts.

There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.

📦 How Supplied / Storage and Handling 93 words

HOW SUPPLIED Sucralfate tablets USP, 1g are supplied as follows: NDC 72578-081-06 in bottles of 30 tablets with child-resistant closure NDC 72578-081-01 in bottles of 100 tablets with child-resistant closure NDC 72578-081-05 in bottles of 500 tablets White to off-white, capsule shaped, biconvex, scored, uncoated tablets, debossed with "6" and "75" on either side of score and plain on other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Distributed by: Viona Pharmaceuticals Inc.

Cranford, NJ 07016 Rev.: 11/2023

📋 Description 41 words

DESCRIPTION Sucralfate tablets, USP contain sucralfate USP and sucralfate is an α-D-glucopyranoside, β-D fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: magnesium stearate, microcrystalline cellulose, and corn starch. Therapeutic category: antiulcer. figure

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