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Sucralfate 1 g Tablet, 100-count — NDC 60687-695-01 (Billing 60687-0695-01)

by American Health Packaging · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Sucralfate 1 g Tablet from American Health Packaging, no longer marketed (first marketed May 2023), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026; retail pharmacies pay about $0.1787 per tablet (NADAC). It is this product's only package size.

NDC 60687-0695-01
🏷️ FDA NDC (as labeled) 60687-695-01 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🚨
Active recall for this product.
Class II · Oct 9, 2025 — CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. (Amerisource Health Services LLC) · FDA recall D-0027-2026
Lots / codes: Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025. · reported Oct 22, 2025
Class II · Jul 29, 2025 — CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. (Amerisource Health Services LLC) · FDA recall D-0598-2025
Lots / codes: Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026. · reported Sep 3, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60687-695-01
Product NDC 60687-695
11-digit billing NDC 60687069501
NCPDP billing unit EA — each (per item)
RxCUI 314234
UNII XX73205DH5
Application # ANDA074415
SPL Set ID e7364686-3638-4061-ae4a-62b1df7af9d0
Established class (EPC) Aluminum Complex
Chemical class Organometallic Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2023-05-11
Marketing end 2026-07-31
Route ORAL
Dosage form TABLET
Substance SUCRALFATE
TE code (Orange Book) AB · RLD · RS

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

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
Quick answers
  • GSN (GCN sequence number): 002766
  • GCN: 08200
  • HICL (First Databank): 001186
  • AHFS class code: 56:28.32.00
  • RxCUI (RxNorm): 314234
Why two NDCs? The FDA registers this code as 60687-695-01 — 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 → 60687-0695-01. 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.

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
  • It treats an active duodenal ulcer, which is a sore in the first part of your small intestine. Treatment usually lasts up to 8 weeks. The tablets can also be used at a lower dose t...
  • Take it by mouth on an empty stomach, as your prescriber directs. For an active ulcer, the label describes four doses a day. Keep going for the full course even if you feel better,...
  • Yes, for pain relief if your doctor allows. Just keep them at least 30 minutes before or after your sucralfate dose.
  • Constipation is the most common one, though most people have no trouble. Some get nausea, diarrhea, dry mouth, dizziness or a rash. Call your doctor if something bothers you or doe...
📖 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.

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 $0.179 $17.87 / 100 tablet
Medicaid paysCMS SDUD · 12 mo $0.4515 $45.15 / 100 tablet
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 Mar 2026 Jul 2026 $0.224 $0.179
▼ Down 20% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
60687-0695-01 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2022-12-20 Jul 31, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sucralfate 1 g 00093-2210-01 Teva 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 51079-0753-20 Mylan 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 59762-0401-01 Mylan 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 60219-1656-01 Amneal 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 62135-0436-90 Chartwell 90 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 69238-1656-01 Amneal 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 g 72578-0081-01 Viona 100 tablets $0.173 AB Availability likely save 3%
Sucralfate 1 gthis 60687-0695-01 American 100 tablets $0.179 AB Discontinued —
Carafate 1 g 58914-0171-10 Allergan, 100 tablets $4.731 AB Availability likely +2547%
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 Discontinued —
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAmerican Health Packaging
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA074415 (ANDA)
Labeler code60687
First marketedMay 2023
Product typeHuman Prescription Drug
Portfolio673 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.

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 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 164 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 Nostrum Laboratories, Inc. at [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 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.

🔄 Drug Interactions 167 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 tablets should be administered separately from other drugs when alterations in bioavailability are felt to be critical.

In these cases, patients should be monitored appropriately.

🤰 Pregnancy 68 words ▾

Pregnancy Teratogenic effects 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 155 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 180 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 ulceradherent 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 65 words ▾

HOW SUPPLIED Sucralfate 1 g tablets, USP are supplied in unit dose packages of 100 (10 x 10). White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Unit dose packages of 100 (10 x 10) NDC 60687‐695‐01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

📋 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. Structural Formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS The physician should read the " PRECAUTIONS " section when considering the use of this drug in pregnant or pediatric patients, or patients of childbearing potential. Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.

Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility. 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.

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 tablets should be administered separately from other drugs when alterations in bioavailability are felt to be critical.

In these cases, patients should be monitored appropriately. Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity.

A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted. Pregnancy Teratogenic effects 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. Nursing Mothe… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 34 words ▾

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

🔬 Clinical Studies ~2 min read ▾

Clinical Trials Acute Duodenal Ulcer Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed: STUDY 1 Treatment Groups Ulcer Healing/ No. Patients 2 wk 4 wk (Overall) Sucralfate 37/105 (35.2%) 82/109 (75.2%) Placebo 26/106 (24.5%) 68/107 (63.6%) STUDY 2 Treatment Groups Ulcer Healing/ No.

Patients 2 wk 4 wk (Overall) Sucralfate 8/24 (33%) 22/24 (92%) Placebo 4/31 (13%) 18/31 (58%) The sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks. The poorer result in the first study may have occurred because sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study. In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used.

Maintenance Therapy After Healing of Duodenal Ulcer Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers. In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below.

Duodenal Ulcer Recurrence Rate (%) Drug Months of Therapy n 1 2 3 4 Sucralfate 122 20 P<0.05 30 38 P<0.01 42 Placebo 117 33 46 55 63 In this study, prn antacids were not permitted. In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated. Median symptom scores between the sucralfate and placebo groups were not significantly different.

A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results: Duodenal Ulcer Recurrence Rate (%) Drug n 6 months 12 months Sucralfate 48 19 P<0.002 27 Placebo 46 54 65 In this study, prn antacids were permitted. Data from placebo-controlled studies longer than 1 year are not available.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 64 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.

📄 Package Label / Principal Display Panel 120 words ▾

Package/Label Display Panel – Carton – 1 g NDC 60687- 695 -01 Sucralfate Tablets, USP 1 gram 100 Tablets (10 x 10) Rx Only Each Tablet Contains: Sucralfate, USP ......................................................... 1 gram Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 29033-003, Nostrum Laboratories, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 769501 0469501/0924 1 g Sucralfate Tablets Carton

Package/Label Display Panel – Blister – 1 g Sucralfate Tablet, USP 1 gram 1 gram Sucralfate Tablet Blister

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

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 this package alone, 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 – Q1 2026 · 5 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
150
Units reimbursed last 4 qtrs
630
Gross reimbursed last 4 qtrs
$284.44
Avg / prescription
$1.90
Avg / unit
$0.4515
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$0.4515
gross reimbursed
vs
NADAC / ea
$0.1787
acquisition cost
=
Spread
+$0.2728
+153% 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 ⓘ
31% FFS 69% MCO
Fee-for-service · 46 Rx Managed care · 104 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 78 units · 1.3 per 100k residents MO Kentucky: 526 units · 11.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 26 units · 0.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.411.6
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 11.6 /100k
2 Missouri 1.3 /100k
3 Tennessee 0.4 /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.

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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
American Health Packaging 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.
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.