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Rebyota Donor Human Stool 50000000000 [CFU]/150mL Suspension, 150 mL
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.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 · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1440 | $65.604 / J1440 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rebyota 50000000000 [CFU]/150mLthis 55566-9800-02 | Ferring | 150 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Nov 30, 2034 |
Is there a biosimilar for REBYOTA RECTAL SUSPENSION?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55566-9800-02 You're viewing this | 1 CARTON in 1 CARTON (55566-9800-2) / 1 BAG in 1 CARTON (55566-9800-1) / 150 mL in 1 BAG (55566-9800-0) | 2023-01-09 | Active |
🧭 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 | ✓ Available |
| 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 | ✓ Available |
| 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
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI. REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. ( 1 ) Limitation of Use: REBYOTA is not indicated for treatment of CDI.
Limitation of Use: REBYOTA is not indicated for treatment of CDI.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For rectal administration only. For rectal administration only. Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI. ( 2 ) Administer a single dose of 150 mL rectally of REBYOTA. ( 2 )
2.1Dose A single dose is 150 mL.
2.2Preparation Prior to use, thaw REBYOTA completely by placing the carton in a refrigerator, 2°C to 8°C (36°F to 46°F), for approximately 24 hours. REBYOTA carton may be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) and used within 5 days, including thawing time. DO NOT thaw using a heat source such as a microwave or hot water.
Condensation is normal after thawing. Remove the thawed REBYOTA carton from the refrigerator. Remove the bag containing thawed REBYOTA from the outer carton and the inner carton insert.
DO NOT remove the bag containing thawed REBYOTA from the sealed outer bag. Locate an Administration Set (supplied), water-soluble lubricant (not included) and a disposable underpad (not included) (See Figure 1 ). 1.
Open the administration set and close the pinch clamp by pushing the clamp until it is fully closed (see Figure 2 ). 2. Remove the tab from the spike port of the bag containing thawed REBYOTA and remove the cap from the administration tube spike.
Insert the administration tube spike through the spike port of the bag containing thawed REBYOTA (see Figure 3 ). DO NOT remove air from the administration tube prior to insertion to avoid loss of REBYOTA. Figure 1 Figure 2 Figure 3
2.3Administration Administer REBYOTA 24 to 72 hours after the last dose of antibiotics for CDI. 1. Prepare the patient for administration by requesting they empty their bladder and bowel, if possible.
Place the patient in the left-side position or the knee-chest position with a disposable underpad beneath the patient (see Figures 4 and 5 ). 2. Apply water-soluble lubricant to the administration tube tip.
Gently insert the administration tube tip into the rectum about 12 cm (5 inches) in a direction pointed slightly toward the navel (umbilicus) (see Figure 6 ). 3. Hold the administration tube in place with one hand for the entire procedure to maintain the tube position in the rectum.
With the other hand, open the pinch clamp on the administration tube, and then gradually raise the bag to allow delivery of REBYOTA via gravity flow (see Figure 7 and 8 ). DO NOT allow the administration tube to sag or loop as this will prevent the entire dose from being delivered. DO NOT squeeze the bag to deliver REBYOTA as this could be uncomfortable for the patient.
DO NOT hang the bag from an IV stand. 4. When the entire dose has been delivered, close the pinch clamp and then slowly withdraw the tube.
Take care to prevent any residual REBYOTA remaining in the tube from leaking out. NOTE: Some REBYOTA will remain in the tube after administration. 5.
Keep the patient in the left-side position or the knee-chest position for up to 15 minutes to minimize any cramping that may occur (see Figure 9 and 10 ). There are no restrictions on the patient's use of the restroom. Dispose of all components in medical waste.
Figure 4 and Figure 5 Figure 6 Figure 7 and Figure 8 Figure 9 and Figure 10
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Suspension. A single dose is 150 mL. Suspension. A single dose is 150 mL. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components [see Description 11 ] . Severe allergic reactions (e.g. anaphylaxis) to any component of REBYOTA. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS
5.1Transmissible infectious agents Because REBYOTA is manufactured from human fecal matter it may carry a risk of transmitting infectious agents. Any infection suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Ferring Pharmaceuticals Inc.
5.2Management of acute allergic reactions Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs following administration of REBYOTA.
5.3Potential presence of food allergens REBYOTA is manufactured from human fecal matter and may contain food allergens. The potential for REBYOTA to cause adverse reactions due to food allergens is unknown.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%). The most commonly reported (≥ 3%) adverse reactions occurring in adults following a single dose of REBYOTA were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%) ( Table 1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
( 6 )
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of REBYOTA was evaluated in 2 randomized, double-blind clinical studies (Study 1: NCT03244644 and Study 2: NCT02299570) and 3 open-label clinical studies (NCT01925417, NCT02589847, NCT03931941) conducted in the United States and Canada.
A total of 978 adults 18 years of age and older with a history of 1 or more recurrences of Clostridioides difficile (CDI) infection and whose symptoms were controlled 24 – 72 hours post-antibiotic treatment were enrolled and received 1 or more doses of REBYOTA; 595 of whom received a single dose of REBYOTA. In the 2 randomized, double-blind clinical studies, 131 adults were originally randomized to receive placebo and 48 crossed over to receive an open-label dose of REBYOTA after additional CDI recurrence. Overall, across the 5 studies, the median age of participants was 64 years and 67.2 % were female.
The racial and ethnic distribution was as follows: 93.8% were white, and 2.4% were of Hispanic or Latino ethnicity. No meaningful differences in demographic characteristics occurred across the treatment groups. Study 1 and Study 2 excluded individuals with celiac disease, Inflammatory Bowel Disease, Irritable Bowel Syndrome, and chronic diarrhea.
Individuals with these conditions were not excluded from one of the open-label studies (NCT03931941), and individuals with food allergies were not excluded from any of the 5 clinical studies. Adverse Reactions Across the 5 clinical studies, participants recorded solicited adverse events in a diary for the first 7 days after each dose of REBYOTA or placebo. Participants were monitored for all other adverse events by queries during scheduled visits, with duration of follow-up ranging from 6 to 24 months after the last dose.
In Study 1, a multi-center, double-blind randomized (2:1), placebo-controlled trial conducted in the United States and Canada, 180 adults 18 years of age and older received a single dose of REBYOTA and 87 received placebo. Participants with a recurrence of CDI (rCDI) during the first 8 weeks after receipt of REBYOTA or placebo were censored from analysis at the time of rCDI . During the first two weeks following a dose of REBYOTA or placebo, 34 participants (18.9%) and 24 participants (27.6%) respectively, were censored.
Overall, during the 8 week follow up period, 47 REBYOTA recipients (26.1%) and 30 placebo recipients (34.5%) were censored from analysis. In an analysis of solicited and unsolicited adverse events reported in Study 1, the most common adverse reactions (defined as adverse events assessed as definitely, possibly, or probably related to Investigational Product by the investigator) reported by ≥3% of REBYOTA recipients, and at a rate greater than that reported by placebo recipients, were abdominal pain, (8.9%), diarrhea (7.2%), abdominal distention (3.9%), flatulence (3.3%), and nausea (3.3%) (Table 1).
Table 1: Adverse Reactions Adverse reactions were defined as solicited and unsolicited adverse events that were assessed as definitely, possibly or probably related to treatment by the study inves…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary REBYOTA is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.
8.2Lactation REBYOTA is not absorbed systemically by the mother following rectal administration, and breastfeeding is not expected to result in exposure of the child to REBYOTA.
8.4Pediatric Use Safety and effectiveness of REBYOTA in individuals younger than 18 years of age have not been established.
8.5Geriatric Use Of the 978 adults who received REBYOTA, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). Data from clinical studies of REBYOTA are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary REBYOTA is not absorbed systemically following rectal administration, and maternal use is not expected to result in fetal exposure to the drug.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of REBYOTA in individuals younger than 18 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 978 adults who received REBYOTA, 48.8% were 65 years of age and over (n=477), and 25.7% were 75 years of age and over (n=251). Data from clinical studies of REBYOTA are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of REBYOTA has not been established.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of REBYOTA has not been established.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied REBYOTA and the administration set are shipped together in a box. Each box may contain up to 6 cartons of REBYOTA and up to 6 administration sets. Each carton of REBYOTA (NDC 55566-9800-2) contains a single dose.
16.2Storage and Handling REBYOTA contains live microorganisms. It is important to follow the storage requirements. Upon Receipt : Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F).
Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). Do not refreeze REBYOTA after thawing. Store the administration set at 10°C to 34°C (50°F to 93°F).
DO NOT store the administration set in the freezer. Before Using : Prior to use, thaw REBYOTA completely by placing carton in a refrigerator (2°C to 8°C, 36°F to 46°F) for approximately 24 hours. Do not refreeze REBYOTA after thawing.
Dispose of all components in medical waste.
📦 Storage and Handling ▾
16.2Storage and Handling REBYOTA contains live microorganisms. It is important to follow the storage requirements. Upon Receipt : Store the REBYOTA carton in an ultracold freezer (-60°C to -90°C, -76°F to -130°F).
Alternatively, store in a refrigerator (2°C to 8°C, 36°F to 46°F) for up to 5 days (including thaw time). Do not refreeze REBYOTA after thawing. Store the administration set at 10°C to 34°C (50°F to 93°F).
DO NOT store the administration set in the freezer. Before Using : Prior to use, thaw REBYOTA completely by placing carton in a refrigerator (2°C to 8°C, 36°F to 46°F) for approximately 24 hours. Do not refreeze REBYOTA after thawing.
Dispose of all components in medical waste.
📋 Description ▾
11 DESCRIPTION REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens.
Donors do not have dietary restrictions with respect to potential food allergens. The fecal microbiota suspension is the filtrate generated by processing the fecal matter in a pre-defined ratio with a solution of polyethylene glycol (PEG) 3350 and saline. Each 150mL dose of REBYOTA contains between 1×10 8 and 5×10 10 colony forming units (CFU) per mL of fecal microbes including >1×10 5 CFU/mL of Bacteroides , and contains not greater than 5.97 grams of PEG3350 in saline.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients that REBYOTA is manufactured from human fecal matter and may contain food allergens. Inform patients to notify their physician if persistent diarrhea, defined as 3 or more loose bowel movements within a 24-hour period for 2 consecutive days, returns following REBYOTA administration. Patients should not take any oral antibiotic therapy for up to 8 weeks after administration of REBYOTA unless directed by their physician.