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sucralfate 1 g/10mL Suspension, 420 mL — NDC 0378-9205-35 (Billing 00378-9205-35)

by Mylan Pharmaceuticals Inc. · 420 mL in 1 BOTTLE, PLASTIC

This is a package of 420 mL of sucralfate 1 g/10mL Suspension from Mylan Pharmaceuticals Inc., no longer marketed (first marketed Sep 2022), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $0.1241 per mL (NADAC). It is this product's only package size.

NDC 00378-9205-35
🏷️ FDA NDC (as labeled) 0378-9205-35 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0378-9205-35 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0378 labeler · 9205 product · 35 package
Package marketed since
Sep 22, 2022
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Billing quantity
420 mL per package
Barcode (UPC-A, from the NDC)
3 0378920535 3
Medicaid fills, this package
6,972 prescriptions in the last four reported quarters
FDA record last changed
Aug 6, 2026
⚠️
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 Sep 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) 0378-9205-35
Product NDC 0378-9205
11-digit billing NDC 00378920535
NCPDP billing unit ML — per mL (volume)
RxCUI 313123
UNII XX73205DH5
Application # ANDA212913
SPL Set ID 1e781cc0-24ec-4028-8262-dcef9873ea1f
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 Sep 2026)
Marketing start 2022-09-22
Marketing end 2026-09-30
Route ORAL
Dosage form SUSPENSION
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 016133
GCN 07651
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/10 ML SUSP
FDB brand name Sucralfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016133
  • GCN: 07651
  • HICL (First Databank): 001186
  • AHFS class code: 56:28.32.00
  • RxCUI (RxNorm): 313123
Why two NDCs? The FDA registers this code as 0378-9205-35 — a 4-4-2 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 labeler segment → 00378-9205-35. 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/10 ML SUSP 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.

🧪 Full Sucralfate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.124 $52.12 / 420 ml
Medicaid paysCMS SDUD · 12 mo $0.2092 $87.86 / 420 ml
Medicare drug plans payPart D · Q2 2026 $0.2427 $101.93 / 420 ml
NADAC price history (per mL) — tap or hover for the price & month
Nov 2022 Dec 2025 Apr 2026 Sep 2026 $0.342 $0.115
▼ Down 62% over the last 14 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
00378-9205-35 You're viewing this Main listing 420 mL in 1 BOTTLE, PLASTIC 2022-09-22 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sucralfate 1 g/10mL 50742-0386-42 Ingenus 420 ml $0.115 AB Discontinued save 7%
Sucralfate 1 g/10mL 66689-0305-16 VistaPharm, 1 bottle $0.116 AB Availability likely save 6%
sucralfate 1 g/10mLthis 00378-9205-35 Mylan 420 ml $0.124 AB Discontinued —
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 —
sucralfate 1 g/10mL 64380-0149-01 Strides 420 ml $0.124 AB Availability likely —
Sucralfate 1 g/10mL 65162-0062-05 Amneal 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 52817-0840-16 TruPharma, 473 ml $0.137 AB Availability likely +10%
Carafate 1 g/10mL 58914-0170-14 Allergan, 414 ml $0.609 — FDA listed +391%
Sucralfate 1 g/10mL 00121-0974-00 PAI 10 cups — AB FDA listed —
Sucralfate 1 g/10mL 00904-7470-01 Major 30 cups — AB FDA listed —
Sucralfate 1 g/10mL 17856-0306-01 ATLANTIC 72 cups — AB FDA listed —
Sucralfate 1 g/10mL 42291-0781-42 AvKARE 420 ml — AB FDA listed —
Sucralfate 1 g/10mL 50268-0745-14 AvPAK 40 cups — AB FDA listed —
Sucralfate 1 g/10mL 54738-0005-42 Richmond 420 ml — AB FDA listed —
Sucralfate 1 g/10mL 55154-4348-05 Cardinal 5 cups — AB FDA listed —
Sucralfate 1 g/10mL 55154-5790-05 Cardinal 5 cups — AB FDA listed —
Sucralfate 1 g/10mL 60687-0738-08 American 10 cups — AB FDA listed —
Sucralfate 1 g/10mL 68094-0041-61 Precision 10 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/10mL 81033-0149-44 Kesin 40 cups — AB FDA listed —
Sucralfate 1 g/10mL 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 —
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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 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.

🧪 Avoiding an ingredient? See Sucralfate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerMylan Pharmaceuticals Inc.
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA212913 (ANDA)
Labeler code00378
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio473 products on file

More NDCs from Mylan Pharmaceuticals Inc. labeler code 00378

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

INDICATIONS AND USAGE Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

⏱️ Dosage and Administration 159 words ▾

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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Sucralfate oral suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

⚠️ Warnings 31 words ▾

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 180 words ▾

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 168 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 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 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 156 words ▾

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 83 words ▾

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 183 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%.

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 79 words ▾

HOW SUPPLIED Sucralfate Oral Suspension is a pink oral suspension containing 1 g of sucralfate, USP per 10 mL. It is available as follows: NDC 0378-9205-35 bottle containing 420 mL of liquid suspension SHAKE WELL BEFORE USING. AVOID FREEZING.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Halo Pharmaceutical Canada, Inc.

17 800 Lapointe Mirabel, QC J7J 0W8 Canada C-11240-3 Revised: 1/2020 HLC:SUCROS:R2

📋 Description 79 words ▾

DESCRIPTION Sucralfate oral suspension contains sucralfate and sucralfate is an α-D-Glucopyranoside, ß-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex. x = 8 to 10, and y = 22 to 31 Sucralfate oral suspension for oral administration contains 1 g of sucralfate per 10 mL. Sucralfate oral suspension also contains: artificial cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone (which contains polydimethylsiloxane and silicon dioxide) and sorbitol solution.

Therapeutic category: antiulcer. Sucralfate Structural Formula

⚠️ Precautions ~3 min read ▾

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 ex… [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 90 words ▾

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%) P = 0.016 66(46%) P = 0.001 95(66%) P = 0.0001 Placebo 147 10(7%) 39(27%) 58(39%) Equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.

📄 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 116 words ▾

PRINCIPAL DISPLAY PANEL – 1 g/10 mL NDC 0378-9205-35 Sucralfate Oral Suspension 1 g/10 mL FOR ORAL ADMINISTRATION ONLY SHAKE WELL BEFORE USING AVOID FREEZING Rx only One 420 mL Bottle Each 10 mL (2 teaspoons) sucralfate oral suspension contains 1 g sucralfate, USP. Usual Dosage: Recommended adult dosage is 1 g (2 teaspoons) four times a day on an empty stomach. See accompanying prescribing information.

WARNING: Keep this and all medication out of the reach of children. Pharmacist: Dispense as is. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Mfd. in Canada for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. HLC:9205:OS:R3-A C-11240-3 Mylan.com Sucralfate Oral Suspension 1 g/10 mL Label

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
7K
Units reimbursed last 4 qtrs
4.6M
Gross reimbursed last 4 qtrs
$966.1K
Avg / prescription
$138.57
Avg / unit
$0.2092
Latest quarter Q1 2026
1.5KRx
Medicaid pays / mL
$0.2092
gross reimbursed
vs
NADAC / mL
$0.1241
acquisition cost
=
Spread
+$0.0851
+69% vs cost
What Medicaid paid per mL (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 ⓘ
37% FFS 63% MCO
Fee-for-service · 2,606 Rx Managed care · 4,366 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 20,409 units · 261 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 17,868 units · 302 per 100k residents WI Michigan: no data reported MI New York: 142,316 units · 727 per 100k residents NY Vermont: no data reported VT New Hampshire: 65,406 units · 4,665 per 100k residents 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: 20,666 units · 165 per 100k residents IL Indiana: no data reported IN Ohio: 64,852 units · 550 per 100k residents OH Pennsylvania: 23,969 units · 185 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 1,285,318 units · 18,359 per 100k residents MA California: 89,935 units · 231 per 100k residents CA Utah: no data reported UT Colorado: 10,152 units · 173 per 100k residents CO Nebraska: no data reported NE Missouri: 17,913 units · 289 per 100k residents MO Kentucky: 143,399 units · 3,168 per 100k residents KY West Virginia: 12,670 units · 716 per 100k residents WV Virginia: 417,125 units · 4,786 per 100k residents VA Maryland: 60,903 units · 985 per 100k residents MD Connecticut: 873,879 units · 24,160 per 100k residents 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: 25,554 units · 359 per 100k residents TN North Carolina: 801,543 units · 7,398 per 100k residents NC South Carolina: 163,316 units · 3,040 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 16,612 units · 363 per 100k residents LA Mississippi: no data reported MS Alabama: 13,918 units · 272 per 100k residents AL Georgia: 256,384 units · 2,325 per 100k residents GA D.C.: 31,745 units · 4,675 per 100k residents DC Hawaii: no data reported HI Texas: 25,377 units · 83.2 per 100k residents TX Florida: 10,683 units · 47.2 per 100k residents FL
Units reimbursed · per 100k residents
47.224,160
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 Connecticut 24,160 /100k
2 Massachusetts 18,359 /100k
3 North Carolina 7,398 /100k
4 Virginia 4,786 /100k
5 D.C. 4,675 /100k
6 New Hampshire 4,665 /100k
7 Kentucky 3,168 /100k
8 South Carolina 3,040 /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?
Mylan 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.
← 00378-9127-98 · Mylan 00378-9320-32 · Mylan →
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.