HomeNDC LookupIngredientsSucralfate › 68788-8946-03
Sucralfate 1 g Tablet, 30-count — NDC 68788-8946-03 package photo

Sucralfate 1 g Tablet, 30-count

by Preferred Pharmaceuticals Inc. · 30 TABLET in 1 BOTTLE (68788-8946-3)
NDC 68788-8946-03
🏷️ FDA NDC (as labeled) 68788-8946-3 billing pads the package segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 100 tablets 68788-8946-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 68788-8946-3
Product NDC 68788-8946
11-digit billing NDC 68788894603
UNII XX73205DH5
Application # ANDA070848
SPL Set ID 5ec71444-cc55-47bd-8abc-b3cfc3b47d8e
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 2015-10-27
Route ORAL
Dosage form TABLET
Substance SUCRALFATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68788-8946-3 — a 5-4-1 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 package segment → 68788-8946-03. 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.

🏭 Manufacturer & labeler

LabelerPreferred Pharmaceuticals Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA070848 (ANDA)
Labeler code68788
First marketedOct 2015
Product typeHuman Prescription Drug
Portfolio825 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

📗 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
ShapeOval
ImprintTEVA;22;10
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 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 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: 100 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 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 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 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 gthis 68788-8946-03 Preferred 30 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

🏛️
2015
On the market since
Oct 2015
📍
2026
Currently FDA-listed
11 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.

📊 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 Marketing startStatus
68788-8946-01 100 TABLET in 1 BOTTLE (68788-8946-1) 2015-10-28 Active
68788-8946-03 You're viewing this 30 TABLET in 1 BOTTLE (68788-8946-3) 2015-10-28 Active

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

Pack size FAQ

What quantity is in NDC 68788-8946-03?
NDC 68788-8946-03 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 68788-8946-03 and NDC 68788-8946-01?
Both are Sucralfate 1 g Tablet — the drug itself is identical. NDC 68788-8946-03 is the 30-count package, while NDC 68788-8946-01 is the 100 tablets package.
What NDC number is used to bill for this package of Sucralfate 1 g Tablet?
Bill NDC 68788-8946-03 — the 11-digit billing format is 68788894603. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 68788-8946-3, 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: 68788-8946-03, written without dashes as 68788894603. 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 68788-8946-03, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals Inc.; the middle segment (8946) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Preferred Pharmaceuticals 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 100 tablets (68788-8946-01). 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?
Preferred Pharmaceuticals 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.

📄 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 66 words

INDICATIONS AND USAGE Sucralfate tablets, USP 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 166 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 TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; 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 Postmarketing 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.

🔄 Drug Interactions 166 words

Drug Interactions Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of sucralfate to alter the absorption of some drugs, sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical.

In these cases, patients should be monitored appropriately.

👥 Use in Specific Populations 126 words

Special Populations Chronic Renal Failure and Dialysis Patients When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine.

Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment.

Sucralfate should be used with caution in patients with chronic renal failure.

🤰 Pregnancy 71 words

Pregnancy Teratogenic Effects Pregnancy category B Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 157 words

Geriatric Use Clinical studies of sucralfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 DOSAGE AND ADMINISTRATION ).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see PRECAUTIONS , Special Populations , Chronic Renal Failure and Dialysis Patients ). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 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 184 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 112 words

HOW SUPPLIED Sucralfate tablets, USP are available as white, capsule-shaped, biconvex, scored tablets, debossed “TEVA” on one side, and “22” and “10” on the scored side, containing 1 gram of sucralfate USP, packaged in bottles of; NDC 68788-8946-3 30 Tablets NDC 68788-8946-1 100 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev.

L 9/2015 Repackaged By: Preferred Pharmaceuticals Inc

📋 Description 46 words

DESCRIPTION Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex. R = SO 3 Al(OH) 2 Tablets for oral administration contain 1 g of sucralfate, USP and the following inactive ingredients: corn starch, magnesium stearate, and microcrystalline cellulose. Therapeutic Category antiulcer Structural formula for sucralfate

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.