Sucraid sacrosidase 8500 [iU]/mL Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Sucrose-specific Enzyme class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 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.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 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 · Q2 2026 | $43.05 | $10,160.41 / 236 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sucraid 8500 [iU]/mLthis 67871-0111-04 | QOL | 2 bottles | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67871-0111-04 You're viewing this | 2 BOTTLE in 1 CARTON (67871-111-04) / 118 mL in 1 BOTTLE (67871-111-01) | 1998-04-09 | Active |
| 67871-0111-07 | 6 BOX in 1 CARTON (67871-111-07) / 25 POUCH in 1 BOX (67871-111-06) / 5 VIAL, SINGLE-USE in 1 POUCH (67871-111-05) / 2 mL in 1 VIAL, SINGLE-USE | 2022-05-25 | Active |
Pack size FAQ
What quantity is in NDC 67871-0111-04?
What NDC number is used to bill for this package of Sucraid sacrosidase 8500 [iU]/mL Solution?
🧭 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) | ✓ 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Administration Information Administer Sucraid with each meal or snack. Mix Sucraid with cold or room temperature water, milk or infant formula prior to administration. Administration of Sucraid in liquids other than water, milk, or infant formula has not been studied and is not recommended.
Do not mix or consume Sucraid with fruit juice. Do not warm or heat the water, milk, or infant formula before or after addition of Sucraid. Administer half of the dose at the beginning of the meal or snack and the other half of the dose during the meal or snack.
Recommended Dosage The recommended dosage is: Patients weighing 15 kg and less: 8,500 International Units (1 mL) administered orally with each meal or snack. Patients weighing more than 15 kg: 17,000 International Units (2 mL) administered orally with each meal or snack. Preparation and Administration Instructions for Patients Weighing 15 kg or Less Multiple-Dose Bottle: Using the measuring scoop provided, add 1 scoop of Sucraid (1 mL) to 60 mL of cold or room temperature water, milk, or infant formula.
Stir to mix well. Administer half of the mixed Sucraid solution (30 mL) at the beginning of the meal or snack and the other half of the mixed solution (30 mL) during the meal or snack. Do not save any of the mixed Sucraid solution for later use.
Rinse the measuring scoop with water. Single-Use Container: Empty the entire contents of the single-use container (2 mL) in 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well.
Divide the mixed Sucraid solution into two separate 60 mL portions. The first portion (60 mL) is for immediate use. • Administer half of the first portion (30 mL) of the mixed Sucraid solution at the beginning of the meal or snack and the other half of the first portion (30 mL) of the mixed Sucraid solution during the meal or snack. Store the second portion of the mixed Sucraid solution (60 mL) at 2°C to 8°C (36°F to 46°F) for up to 24 hours for administration with the next meal or snack. • Discard the mixed Sucraid solution if not used within 24 hours.
Preparation and Administration Instructions for Patients Weighing More than 15 kg Multiple-Dose Bottle: Using the measuring scoop provided, add 2 scoops of Sucraid (2 mL) to 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Administer half of the mixed Sucraid solution (60 mL) at the beginning of the meal or snack and the other half of the mixed Sucraid solution (60 mL) during the meal or snack.
Do not save any of the mixed Sucraid solution for later use. Rinse the measuring scoop with water. Single-Use Container: Empty the entire contents of the single-use container (2 mL) in 120 mL of cold or room temperature water, milk, or infant formula.
Stir to mix well. Administer half of the mixed Sucraid solution (60 mL) at the beginning of the meal or snack and the other half of the mixed solution during the meal or snack (60 mL). Do not save any of the mixed Sucraid solution for later use.
⛔ Contraindications ▾
CONTRAINDICATIONS Sucraid is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain (see WARNINGS).
⚠️ Warnings ▾
WARNINGS Severe Hypersensitivity Reactions Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid. Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION). A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization.
Postmarketing cases of cutaneous hypersensitivity reactions have also been reported. Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur. Sucraid is contraindicated in patients who have had a known hypersensitivity reaction (see CONTRAINDICATIONS).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid.
The reported adverse reactions (number of patients) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1). Hypersensitivity reactions (wheezing, rash, and pruritis) have been reported (see WARNINGS).
🔄 Drug Interactions ▾
Drug Interactions Fruit Juice The acidity in fruit juice may reduce the enzyme activity in Sucraid. Administration of Sucraid with liquids other than water, milk, or infant formula has not been studied and is not recommended (see DOSAGE AND ADMINISTRATION, Administration Instructions).
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Sucraid. Sucraid is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sucraid should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness of Sucraid for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), have been established in pediatric patients aged 5 months and older. Use of Sucraid for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients (see CLINICAL STUDIES and ADVERSE REACTIONS).
🧓 Geriatric Use ▾
Geriatric Use Clinical trials of Sucraid did not include patients 65 years of age and older to determine if they respond differently from younger adult patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Congenital sucrase-isomaltase deficiency (CSID) is a chronic, autosomal recessive, inherited, phenotypically heterogeneous disease with very variable enzyme activity. CSID is usually characterized by a complete or almost complete lack of endogenous sucrase activity, a very marked reduction in isomaltase activity, and a moderate decrease in maltase activity. Sucrase is naturally produced in the brush border of the small intestine, primarily the distal duodenum and jejunum.
Sucrase hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. Isomaltase breaks down disaccharides from starch into simple sugars. Sucraid does not contain isomaltase.
In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Unhydrolyzed sucrose and starch are not absorbed from the intestine and their presence in the intestinal lumen may lead to osmotic retention of water. This may result in loose stools.
Unabsorbed sucrose in the colon is fermented by bacterial flora to produce increased amounts of hydrogen, methane, and water. As a consequence, excessive gas, bloating, abdominal cramps, diarrhea, nausea, and vomiting may occur. Chronic malabsorption of disaccharides may result in malnutrition.
Undiagnosed/untreated CSID patients often fail to thrive and fall behind in their expected growth and development curves. Previously, the treatment of CSID has required the continual use of a strict sucrose-free diet.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 118 mL Multiple-Dose Bottle Sucraid (sacrosidase) Oral Solution is available in 118 mL (4 fluid ounces) multiple-dose translucent plastic bottles, packaged two bottles per carton. Each mL of solution contains 8,500 International Units of sacrosidase. A 1 mL measuring scoop is provided with each bottle.
A full measuring scoop is 1 mL. NDC# 67871-111-04 (2 x 118 mL multiple-dose bottles) Store under refrigeration at 2°C to 8°C (36°F to 46°F). Discard four weeks after first opening due to the potential for bacterial growth.
Protect from heat and light. 2 mL Single-Use Container Sucraid (sacrosidase) Oral Solution is available in 2 mL, single-use containers that are packaged into a foil pouch. Each 2 mL single-use container contains 17,000 International Units of sacrosidase.
Each foil pouch holds a card of 5 containers. Five pouches are then packaged in a box (25 containers). Six boxes are further packaged in a carton (150 containers).
NDC# 67871-111-07 (150 x 2 mL single-use containers) Store under refrigeration, 2°C to 8°C (36°F to 46°F). Protect from light. Single-use container can be removed from refrigeration and stored at 15°C to 25°C (59°F to 77°F) for up to 3 days (72 hours).
Manufactured by: QOL Medical, LLC Vero Beach, FL 32963 U.S. License No. 2195 www.sucraid.com For questions call 1-866-469-3773 Rev <08/24>
📋 Description ▾
DESCRIPTION Sacrosidase is an enzyme with the chemical name of β,D-fructofuranoside fructohydrolase. The enzyme is derived from baker’s yeast ( Saccharomyces cerevisiae ). It has been reported that the primary amino acid structure of this protein consists of 513 amino acids with an apparent molecular weight of 100,000 Da for the glycosylated monomer (range 66,000- 116,000 Da).
Reports also suggest that the protein exists in solution as a monomer, dimer, tetramer, and octomer ranging from 100,000 Da to 800,000 Da. It has an isoelectric point (pI) of 4.5. Sucraid ® (sacrosidase) Oral Solution is an oral enzyme replacement therapy.
Sucraid is a pale yellow to colorless, clear solution with a pleasant, sweet taste. Each milliliter (mL) of Sucraid contains 8,500 International Units (I.U.) of the enzyme sacrosidase, the active ingredient. Sucraid may contain small amounts of papain (see WARNINGS).
Papain is a protein-cleaving enzyme that is introduced in the manufacturing process to digest the cell wall of the yeast and may not be completely removed during subsequent process steps. Sucraid contains sacrosidase in a vehicle comprised of glycerin, water, citric acid, and sodium hydroxide to maintain the pH at 4.0 to 4.7. Glycerol (glycerin) in the amount consumed in the recommended doses of Sucraid has no expected toxicity.
This enzyme preparation is fully soluble with water, milk, and infant formula. DO NOT HEAT SOLUTIONS CONTAINING SUCRAID. Do not put Sucraid in warm or hot liquids (see DOSAGE AND ADMINISTRATION, Administration Instructions).
💬 Information for Patients ▾
Information for Patients See Patient Package Insert and the Instructions for Use.
Patient Information SUCRAID ® (Su-kreid) (sacrosidase) Oral Solution What is SUCRAID? SUCRAID is a prescription medicine for the treatment of people who were born with a lack of (deficiency) sucrase, which is part of congenital sucrase-isomaltase deficiency (CSID). It is not known if SUCRAID is safe and effective in children under 5 months of age.
Do not take or give your child SUCRAID if you or your child: are allergic to yeast, yeast products, glycerin (glycerol), or papain. See the end of this Patient Information leaflet for a complete list of ingredients in SUCRAID. Before you take or give your child SUCRAID, tell your healthcare provider about all of your medical conditions, including if you or your child: have diabetes.
SUCRAID can interact with the food in your diet and may change your blood sugar levels. Your healthcare provider will tell you if your diet or diabetes medicines need to be changed. are pregnant or plan to become pregnant. It is not known if SUCRAID will harm your unborn baby. are breastfeeding or plan to breastfeed.
You and your healthcare provider should decide if you will take SUCRAID while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take or give SUCRAID?
See the detailed Instructions for Use that come with this Patient Information leaflet for instructions about the right way to take or give SUCRAID. SUCRAID should be taken or given exactly as prescribed by your healthcare provider. Do not change the dose of SUCRAID without talking to your healthcare provider.
SUCRAID comes in a 118-mL multiple-dose bottle or a 2-mL single-use container. Your healthcare provider will decide which type of SUCRAID is best for you to use. The dose of SUCRAID depends on body weight.
Your healthcare provider will tell you how much SUCRAID you should take or give your child. The dose for a child 33 pounds (15 kg) or less is 1 mL or 28 drops of SUCRAID in 2 ounces of water, milk, or infant formula. The dose for a child or adult more than 33 pounds (15 kg) is 2 mL or 56 drops of SUCRAID in 4 ounces of water, milk, or infant formula.
SUCRAID can only be dissolved in cold or room temperature water, milk, or infant formula. Do not put SUCRAID in warm or hot liquids. Do not mix SUCRAID with fruit juice.
Do not take or give SUCRAID with fruit juice. Do not warm or heat the mixed solution before taking or giving SUCRAID. Measure your dose or your child’s dose of SUCRAID using the measuring scoop that comes with the SUCRAID bottle.
Do not use a kitchen teaspoon or other measuring device. SUCRAID should be taken or given with each meal or snack. Half of the SUCRAID dose should be taken at the beginning of each meal or snack.
Take or give the remaining SUCRAID dose during the meal or snack. Rinse the measuring scoop with water after each use. SUCRAID does not break down some sugars found in foods that have starch, such as wheat, rice, and potatoes.
Your healthcare provider may tell you to avoid eating foods with starch. What are the possible side effects of SUCRAID? SUCRAID may cause serious side effects, including: severe allergic reactions.
Severe allergic reactions have happened in some people taking SUCRAID. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: difficulty breathing wheezing rash swelling of the face, lips, mouth, or tongue Your healthcare provider may need to monitor you or your child carefully when first starting treatment with SUCRAID. The most common side effects of SUCRAID include: stomach (abdominal) pain vomiting nausea diarrhea constipation problems sleeping headache nervousness dehydration These are not all of the possible side effects of SUCRAID.
Call your doctor for medical advice about side effects. You may report side effe…