Sucralfate 1 g/10mL Suspension — NDC 48433-226-40 (Billing 48433-0226-40)
This is a package of Sucralfate 1 g/10mL Suspension from Safecor Health, LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 313123
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Aluminum Complex class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sucralfate — tap one for details:
Sucralfate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 48433-0226-40 You're viewing this Main listing | 40 CUP, UNIT-DOSE in 1 CASE / 10 mL in 1 CUP, UNIT-DOSE | 2026-07-16 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sucralfate 1 g/10mL 50742-0386-42 | Ingenus | 420 ml | $0.115 | AB | Discontinued | — |
| Sucralfate 1 g/10mL 66689-0305-16 | VistaPharm, | 1 bottle | $0.116 | AB | Availability likely | — |
| sucralfate 1 g/10mL 00378-9205-35 | Mylan | 420 ml | $0.124 | AB | Discontinued | — |
| sucralfate 1 g/10mL 64380-0149-01 | Strides | 420 ml | $0.124 | AB | Availability likely | — |
| Sucralfate 1 g/10mL 82182-0106-14 | Pacific | 420 ml | $0.124 | — | Availability likely | — |
| Sucralfate 1 g/10mL 00713-0791-75 | Cosette | 420 ml | $0.124 | AB | Availability likely | — |
| Sucralfate 1 g/10mL 13668-0754-42 | Torrent | 420 ml | $0.124 | AB | Availability likely | — |
| Carafate 1 g/10mL 58914-0170-14 | Allergan, | 414 ml | $0.609 | — | FDA listed | — |
| Sucralfate 1 g/10mL 60687-0738-08 | American | 10 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 00121-0974-00 | PAI | 10 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 54738-0005-42 | Richmond | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 17856-0306-01 | ATLANTIC | 72 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 55154-5790-05 | Cardinal | 5 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 81033-0149-44 | Kesin | 40 cups | — | AB | FDA listed | — |
| Sucralfate oral suspension 1 g/10mL 68462-0827-61 | Glenmark | 420 ml | — | AB | FDA listed | — |
| sucralfate 1 g/10mL 72162-2479-02 | Bryant | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mLthis 48433-0226-40 | Safecor | 40 cups | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 62135-0106-44 | Chartwell | 420 ml | — | AB | FDA listed | — |
| Sucralfate 1 g/10mL 68999-0106-24 | Chartwell | 10 cups | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Sep 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate oral suspension should be administered 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 oral suspension.
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. 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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
⛔ Contraindications ▾
CONTRAINDICATIONS Sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
⚠️ Warnings ▾
WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of sucralfate oral suspension. Administer sucralfate oral suspension only by the oral route. Do not administer intravenously.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, 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, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting 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 oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with 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.
🔄 Drug Interactions ▾
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 cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to sucralfate oral suspension’s potential to alter the absorption of some drugs, sucralfate oral suspension 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 ▾
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 ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of sucralfate oral suspension 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 ▾
OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral 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 ▾
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%.
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 ▾
HOW SUPPLIED Sucralfate oral suspension 1 g/10 mL is a pink colored, cherry flavored suspension supplied as follows: NDC 48433-226-10 – 10 mL in a Unit-Dose Cup NDC 48433-226-40 – Case of 40 Unit-Dose Cups, each unit-dose cup delivers 10 mL of Sucralfate Oral Suspension SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Rx Only For Institutional Use Only This Package is Not Child Resistant Packaged by: Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Revision: 02/2026 PN5740
📋 Description ▾
DESCRIPTION Sucralfate oral suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate oral suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate oral suspension also contains: cherry flavor, colloidal silicon dioxide NF, FD&C Red #40, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone emulsion USP, and sorbitol solution USP.
Therapeutic category: antiulcer. structure
⚠️ Precautions ▾
PRECAUTIONS The physician should read the “PRECAUTIONS” section when considering the use of sucralfate oral suspension 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.
Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate oral suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of sucralfate oral suspension might be necessary.
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 cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction.
Due to sucralfate oral suspension’s potential to alter the absorption of some drugs, sucralfate oral suspension 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 Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be e… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
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 ▾
CLINICAL TRIALS In a multicenter, double-blind, placebo-controlled study of sucralfate oral suspension, a dosage regimen of 1 gram (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing. Results From Clinical Trials Healing Rates for Acute Duodenal Ulcer Treatment n Week 2 Healing Rates Week 4 Healing Rates Week 8 Healing Rates Sucralfate oral suspension 145 23 (16%)* 66 (46%)† 95 (66%)‡ Placebo 147 10 (7%) 39 (27%) 58 (39%) * P =0.016 † P =0.001 ‡ P =0.0001 Equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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 ▾
PRINCIPAL DISPLAY PANEL NDC 48433-226-40 Rx only Sucralfate Oral Suspension 1 g per 10 mL Contains 40 (10 mL) Unit Dose Cups SHAKE WELL BEFORE USING. AVOID FREEZING. FOR ORAL ADMINISTRATION ONLY Sucralfate Oral Suspension 1 g per 10 mL
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
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) | — 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. |