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Sucralfate 1 g Tablet, 100-count — NDC 62135-0436-01 package photo

Sucralfate 1 g Tablet, 100-count

by Chartwell RX, LLC · 100 TABLET in 1 BOTTLE (62135-436-01)
NDC 62135-0436-01
🏷️ FDA NDC (as labeled) 62135-436-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also comes in: 90 tablets 62135-0436-90
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 62135-436-01
Product NDC 62135-436
11-digit billing NDC 62135043601
NCPDP billing unit EA — each (per item)
RxCUI 314234
UNII XX73205DH5
UPC 0362135436902, 0362135436018
Application # ANDA074415
SPL Set ID 30c0965a-02a0-46b5-aa09-3f5fb5047b22
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 2020-02-17
Route ORAL
Dosage form TABLET
Substance SUCRALFATE
GPI-14 49300010000305
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 62135-436-01 — 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 → 62135-0436-01. 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 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

LabelerChartwell RX, LLC
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA074415 (ANDA)
Labeler code62135
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio521 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
📖 What it is MedlinePlus · NLM

Sucralfate is used to treat and prevent the return of duodenal ulcers (ulcers located in first part of the small intestine). Treatment with other medications, such as antibiotics, may also be necessary to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) Sucralfate is in a class of medications called protectants. It sticks to damaged ulcer tissue and protects against acid and enzymes so healing can occur.

Read the full MedlinePlus article ↗
📗 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.

🧪 Full Sucralfate 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.

💊 What it looks like

Color white
ShapeOval
ImprintN;S1
Size19 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

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 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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 90 tablets
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 69238-1656-01 Amneal 100 tablets $0.172 AB Availability likely —
Sucralfate 1 g 72578-0081-01 Viona 100 tablets $0.172 AB Availability likely —
Sucralfate 1 g 60687-0695-01 American 100 tablets $0.179 AB Discontinued —
Carafate 1 g 58914-0171-10 Allergan, 100 tablets $4.733 AB Availability likely —
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 gthis 62135-0436-01 Chartwell 100 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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 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.
90 tablets62135-0436-90 21 Rx · $77
100 tablets this page62135-0436-01 No Medicaid data
Drug total (last 4 qtrs): 21 Rx · 28 units · $77 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
62135-0436-90 90 TABLET in 1 BOTTLE (62135-436-90) $0.1725 / ea $15.52 2022-11-04 Active
62135-0436-01 You're viewing this 100 TABLET in 1 BOTTLE (62135-436-01) — — 2023-03-13 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 62135-0436-01?
NDC 62135-0436-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 62135-0436-01 and NDC 62135-0436-90?
Both are Sucralfate 1 g Tablet — the drug itself is identical. NDC 62135-0436-01 is the 100-count package, while NDC 62135-0436-90 is the 90 tablets package.
What NDC number is used to bill for this package of Sucralfate 1 g Tablet?
Bill NDC 62135-0436-01 — the 11-digit billing format is 62135043601. 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.

🧭 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 FDA registers it as 62135-436-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62135-0436-01, written without dashes as 62135043601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62135-0436-01, the first segment (62135) is the labeler code FDA assigned to Chartwell RX, LLC; the middle segment (0436) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Chartwell RX, LLC. 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 90 tablets (62135-0436-90). 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?
Chartwell RX, LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 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 Chartwell RX, LLC. at 845-232-1683 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 2700 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 intravenous 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 181 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: 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. In vitro , a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.

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 61 words ▾

HOW SUPPLIED Sucralfate 1 g tablets, USP are supplied in bottles of 90 and 100. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 90...........NDC 62135-436-90 Bottles of 100...........NDC 62135-436-01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71148 Rev. 11/2022 Rx Only

📋 Description 40 words ▾

DESCRIPTION Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula: Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer. image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62135-0435-47 · Chartwell 62135-0437-30 · Chartwell →
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.