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Vowst fecal microbiota spores, live-brpk 30000000 [CFU]/1 Capsule, 12-count — NDC 71881-0400-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vowst fecal microbiota spores, live-brpk 30000000 [CFU]/1 Capsule, 12-count — NDC 71881-400-12 (Billing 71881-0400-12)

by Aimmune Therapeutics, Inc. · 1 BOTTLE in 1 CARTON / 12 CAPSULE in 1 BOTTLE

This is a package of 12 capsules of Vowst fecal microbiota spores, live-brpk 30000000 [CFU]/1 Capsule from Aimmune Therapeutics, Inc., marketed since Apr 2023 and currently FDA-listed. It is this product's only package size.

NDC 71881-0400-12
🏷️ FDA NDC (as labeled) 71881-400-12 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71881-400-12
Product NDC 71881-400
11-digit billing NDC 71881040012
NCPDP billing unit EA — each (per item)
RxCUI 2636542, 2636548
UNII 9K7X6R5BMW
Application # BLA125757
SPL Set ID 99e5a37a-930c-4641-bcdd-7013ec1c15fe
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-26
Route ORAL
Dosage form CAPSULE
Substance DONOR HUMAN STOOL SPORES (ETHANOL TREATED)
Biologic (Purple Book) 351(a)

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

GPI-14 52522020100120
GCN Seq No 084699
GCN 54053
HICL code 048888
Ingredient (HICL) Fecal Microbio Spore,Live-Brpk
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6P
Therapeutic class — specific (HIC3) Fecal Microbiota Transplantation (Fmt)
AHFS code 56:92.00.00
AHFS class Gi Drugs, Miscellaneous
FDB label name VOWST CAPSULE
FDB brand name Vowst
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084699
  • GCN: 54053
  • GPI-14 (Medi-Span): 52522020100120
  • HICL (First Databank): 048888
  • AHFS class code: 56:92.00.00
  • RxCUI (RxNorm): 2636542
Why two NDCs? The FDA registers this code as 71881-400-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71881-0400-12. 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.

Clinical

Label name VOWST CAPSULE Ingredient Fecal Microbio Spore,Live-Brpk

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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 $1,639.36 $19,672.37 / 12 capsules
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
71881-0400-12 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 12 CAPSULE in 1 BOTTLE 2023-04-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vowst 30000000 [CFU]this 71881-0400-12 Aimmune 12 capsules — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2023
First FDA approval
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2035. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 26, 2023 ⏳ ~8.6 yr to latest listed protection

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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Vowstfecal microbiota spores, live-brpk
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 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.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateApr 26, 2035
Common questions
Is there a biosimilar for VOWST CAPSULE?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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

LabelerAimmune Therapeutics, Inc.
FDA applicationBLA125757 (BLA)
Labeler code71881
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio11 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 83 words ▾

1 INDICATIONS AND USAGE VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). ( 1 ) Limitation of Use: VOWST is not indicated for treatment of CDI.

Limitation of Use: VOWST is not indicated for treatment of CDI.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION For oral administration only. ( 2 ) Prior to taking the first dose: Complete antibacterial treatment for rCDI 2 to 4 days before initiating treatment with VOWST. ( 2.1 ) Drink 296 mL (10 oz) of magnesium citrate on the day before and at least 8 hours prior to taking the first dose of VOWST.

In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use). ( 2.1 ) The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days. ( 2.2 ) Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.

( 2.2 )

2.1Prior to taking the first dose Complete antibacterial treatment for recurrent CDI 2 to 4 days before initiating treatment with VOWST. Drink 296 mL (10 oz) magnesium citrate, on the day before and at least 8 hours prior to taking the first dose of VOWST. In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use) [see Clinical Studies (14) ].

Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.

2.2Dosing regimen The dosage of VOWST is 4 capsules taken orally once daily for 3 consecutive days. Take each dose (4 capsules) on an empty stomach prior to the first meal of the day.

💊 Dosage Forms and Strengths 22 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsule. A single dose is 4 capsules. Capsule. A single dose is 4 capsules. ( 3 )

⛔ Contraindications 8 words ▾

4 CONTRAINDICATIONS None . None. ( 4 )

⚠️ Warnings and Cautions 85 words ▾

5 WARNINGS AND PRECAUTIONS

5.1Transmissible infectious agents Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Any infection suspected by a healthcare provider possibly to have been transmitted by this product should be reported by the healthcare provider to Aimmune Therapeutics, Inc. at 1-833-246-2566.

5.2Potential presence of food allergens VOWST is manufactured from human fecal matter and may contain food allergens. The potential for VOWST to cause adverse reactions due to food allergens is unknown.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%). Most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%) and diarrhea (10.0%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics, Inc. at 1-833-246-2566 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 VOWST was evaluated in one Phase 3, randomized, double-blind clinical study (Study 1: NCT03183128) and one Phase 3, open-label clinical study (Study 2: NCT03183141) conducted in the United States and Canada. Adults with confirmed rCDI were required to have symptoms controlled 48 to 96 hours post-antibacterial treatment to be eligible for enrollment and randomization (1:1) to receive either VOWST or placebo (capsules containing 92 ± 4% glycerol in saline) for 3 consecutive days.

Participants with neutropenia (absolute neutrophil count of <500 cells/mm 3 ), toxic megacolon, or small bowel ileus were excluded from these studies. A total of 349 adults 18 years of age and older with rCDI were exposed to VOWST across both Study 1 (n=90) and Study 2 (n=259). Across both Study 1 and Study 2, 99.1% of adults (346/349) received all scheduled doses of VOWST.

Overall, across the 2 studies, the median age of VOWST recipients was 66 years (range, 21-100 years). The racial and ethnic distribution was as follows: 92.3% were white and 5.2% were black. In Study 1, females comprised 68.9% of the VOWST arm compared to 51.1% in the placebo arm.

Rates of the following comorbidities (at study entry) were similar across the VOWST and placebo arms: cardiac disease (33.3% and 31.5%, respectively), immunocompromise/immunosuppression (28.9% and 30.4%, respectively), diabetes (20.0% and 27.2%, respectively), and renal impairment (14.4% and 15.2%, respectively). In Study 2, 68.4% were females and representation of comorbidities was similar to Study 1. Adverse Reactions In Study 1, participants recorded solicited adverse events in a diary for 7 days after completion of the 3-day regimen of VOWST or placebo.

In both Study 1 and Study 2, participants were monitored for unsolicited adverse events by queries during weekly encounters for a period of 8 weeks. Monitoring for serious adverse events and adverse events of special interest (i.e., invasive infections) continued for a period of 6 months after the first dose of study drug. In Study 1, a multi-center, double-blind randomized (1:1), placebo-controlled trial conducted in the United States and Canada, adults 18 years of age and older (range: 18 to 100 years of age) received three daily doses of VOWST (n=90) or placebo (n=92).

Overall through the 24 week follow up period, 12 VOWST recipients (13.3%) and 37 placebo recipients (40.2%) did not complete the study. Participants with a recurrence of CDI during the first 8 weeks after receipt of first dose of VOWST or placebo were eligible to enroll into Study 2 and were no longer followed for safety in Study 1. During the first 8 weeks following VOWST or placebo, 5 participants (5.6%) and 28 participants (30.4%) respectively, did not complete 8 weeks of study participation.

Of these, 4 VOWST recipients and 25 placebo recipients discontinued Study 1 and enrolled in Study 2. In Study 1, within 8 weeks following VOWST or placebo, the most common solicited adverse reactions reported by ≥5% of VOWST recipients, and at a rate greater than that reported by placebo recipients, were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), and c…

🔄 Drug Interactions 27 words ▾

7 DRUG INTERACTIONS VOWST contains bacterial spores; therefore, antibacterials should not be administered concurrently with VOWST. Antibacterials should not be administered concurrently with VOWST. ( 7 )

👥 Use in Specific Populations 216 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of VOWST in pregnant individuals. Developmental toxicity studies in animals have not been conducted with VOWST.

8.2Lactation Risk Summary It is not known whether VOWST is excreted in human milk. Data are not available to assess the effects of VOWST on the breastfed infant or on milk production/excretion.The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for VOWST and any other potential adverse effects on the breastfed child from VOWST or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of VOWST in individuals younger than 18 years of age have not been established.

8.5Geriatric Use Of the 349 adults who received VOWST, 52.4% were 65 years of age and over (n=183), and 28.1% were 75 years of age and over (n=98). Data from clinical studies of VOWST are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.

🤰 Pregnancy 69 words ▾

8.1Pregnancy Risk Summary All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data on use of VOWST in pregnant individuals. Developmental toxicity studies in animals have not been conducted with VOWST.

🧒 Pediatric Use 21 words ▾

8.4Pediatric Use The safety and effectiveness of VOWST in individuals younger than 18 years of age have not been established.

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use Of the 349 adults who received VOWST, 52.4% were 65 years of age and over (n=183), and 28.1% were 75 years of age and over (n=98). Data from clinical studies of VOWST are not sufficient to determine if adults 65 years of age and older respond differently than younger adults.

🧬 Clinical Pharmacology 17 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of VOWST has not been established.

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action The mechanism of action of VOWST has not been established.

📦 How Supplied / Storage and Handling 56 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VOWST is supplied as capsules in bottles with child-resistant caps. Each bottle contains 12 white capsules imprinted with "SER109". Each bottle is supplied in a carton. Bottles of 12 capsules: NDC 71881-400-12. Store VOWST in the original packaging at 2° to 25°C (36° to 77°F). Do not store in the freezer.

📦 Storage and Handling 19 words ▾

Store VOWST in the original packaging at 2° to 25°C (36° to 77°F). Do not store in the freezer.

📋 Description 105 words ▾

11 DESCRIPTION VOWST (fecal microbiota spores, live-brpk) is a bacterial spore suspension in capsules for oral administration. VOWST is manufactured from human fecal matter sourced from qualified donors. Human fecal matter donations are routinely tested for a panel of transmissible pathogens.

Donors do not have dietary restrictions with respect to potential food allergens. The spore suspension is generated by treating fecal matter with ethanol to kill organisms that are not spores, followed by filtration steps to remove solids and residual ethanol. Each capsule of VOWST contains between 1×10 6 and 3×10 7 Firmicutes spore colony forming units in 92 ± 4% (w/w) glycerol in saline.

💬 Information for Patients 29 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients not to take VOWST concurrently with antibacterials [see Drug Interactions (7) ].

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Vowst — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Vowst. 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
$20.73M
Claims incl. refills
1.1K
Beneficiaries
1K
Spend / beneficiary
$19,764.53
Spend / claim
$19,340.48
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fecal microbiota spores, live-brpk — the ingredient across all brands.

Top reported reactions

Diarrhoea549
Clostridium Difficile Infection327
Clostridium Test Positive145
Abdominal Pain106
Nausea90
Constipation80
Abdominal Distension74

Reporter sex

0 reports

Serious outcomes

Death13
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 285 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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) ✓ 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.
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aimmune Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aimmune Therapeutics, 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.
← 71879-0001-01 · EyePoint 71883-0050-02 · Oracle →
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.