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Eohilia Budesonide 2 mg/10mL Suspension — NDC 64764-105-00 (Billing 64764-0105-00)

by TAKEDA PHARMACEUTICALS AMERICA, INC. · 10 POUCH in 1 CARTON / 10 mL in 1 POUCH

This is a package of Eohilia Budesonide 2 mg/10mL Suspension from TAKEDA PHARMACEUTICALS AMERICA, INC., marketed since Feb 2024 and currently FDA-listed.

NDC 64764-0105-00
🏷️ FDA NDC (as labeled) 64764-105-00 billing pads the product segment with a zero
This package
Contains10 mL in 1 pouch Pack sizes2 compare ↓
Also priced by: Part D plans $3.22/unit — full pricing hub ↓
Product page 64764-0105-60 Also comes in: 60 pouches 64764-105-60
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

⚠️
Other active recalls for Budesonide (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 29, 2026 — Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0607-2026
Class II · Jun 30, 2025 — Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. (Cipla USA, Inc.) · FDA recall D-0541-2025
Class II · Jan 8, 2024 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0275-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64764-105-00
Product NDC 64764-105
11-digit billing NDC 64764010500
NCPDP billing unit ML — per mL (volume)
RxCUI 2675280, 2675286
UNII Q3OKS62Q6X
Application # NDA213976
SPL Set ID 56f2023a-69b2-4470-b4ad-af7ec1be527a
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-09
Route ORAL
Dosage form SUSPENSION
Substance BUDESONIDE

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

GPI-14 22100012001820
GCN Seq No 085727
GCN 55273
HICL code 006545
Ingredient (HICL) Budesonide
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name EOHILIA 2 MG/10 ML PACKET
FDB brand name Eohilia
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085727
  • GCN: 55273
  • GPI-14 (Medi-Span): 22100012001820
  • HICL (First Databank): 006545
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 2675280
Why two NDCs? The FDA registers this code as 64764-105-00 — 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 → 64764-0105-00. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Corticosteroids, potent (group III), Corticosteroids
How it works Corticosteroid Hormone Receptor Agonists
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 EOHILIA 2 MG/10 ML PACKET Ingredient Budesonide
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation. Depending on the product, that means asthma, Crohn’s disease, ulcerative colitis, eosinophilic esophagitis or IgA nephropathy. Your product was chosen for yo...
  • No. It is for long-term control, not quick relief. If your asthma gets worse and your usual rescue medicine doesn’t help, contact your doctor right away.
  • Can I use my budesonide inhaler or nebulizer for a sudden asthma attack?
  • Rinse your mouth with water after each use and don’t swallow it. This lowers the chance of a yeast infection (thrush). Tell us if you notice white patches or soreness.
📖 Read our full Budesonide guide →
8
Nutrient depletion considerations

Budesonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Budesonide 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 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 $3.22 $321.84 / 100 ml
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 Per unit Per pack Marketing startMarketing endStatus
64764-0105-00 You're viewing this 10 POUCH in 1 CARTON / 10 mL in 1 POUCH — — 2024-02-09 — Active
64764-0105-60 64764-105-60 Main listing 60 POUCH in 1 CARTON / 10 mL in 1 POUCH $3.29 / mL $1,972.31 2024-02-09 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 pouch in 1 carton / 10 ml in 1 pouch.
What NDC number is used to bill for this package of Eohilia Budesonide 2 mg/10mL Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eohilia 2 mg/10mLthis 64764-0105-00 TAKEDA 10 pouches — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2024
First FDA approval
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🛡️
2039
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 9, 2024 RLD RS ⏳ ~12.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9119863 — method of use (U-3820)
US 8975243 — method of use (U-3820)
US 8497258 — method of use (U-3820)
US 8324192 — method of use (U-3820)
US 11564934 — method of use (U-3820)
US 11357859 — method of use (U-3820)
US 11197822 — drug product
US 11413296 — drug product
US 10293052 — drug product
US 11260064 — drug product
US 8679545 — drug product
US 9050368 — drug product
Exclusivity NP
Exclusivity ODE-466
2024 2026 2028 2030 2032 2034 2036 2038
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (12)
PatentTypeUse codeExpires
US 9119863 ↗ Method of use U-3820 Nov 9, 2026
US 8975243 ↗ Method of use U-3820 Nov 9, 2026
US 8497258 ↗ Method of use U-3820 Nov 9, 2026
US 8324192 ↗ Method of use U-3820 Aug 3, 2029
US 11564934 ↗ Method of use U-3820 Jan 10, 2039
US 11357859 ↗ Method of use U-3820 Nov 12, 2028
US 11197822 ↗ Drug product — Nov 9, 2026
US 11413296 ↗ Drug product — Nov 9, 2026
US 10293052 ↗ Drug product — Nov 22, 2028
US 11260064 ↗ Drug product — Jan 10, 2039
US 8679545 ↗ Drug product — Nov 9, 2026
US 9050368 ↗ Drug product — Aug 1, 2029
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductFeb 9, 2027
ODE-466Orphan Drug Exclusivity (7-year)Feb 9, 2031
Common questions
Is there a generic version of EOHILIA 2 MG/10 ML PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for EOHILIA 2 MG/10 ML PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2039 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • 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.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII BUC5I9595W
    A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
  • UNII LX22YL083G
    A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

16 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

LabelerTAKEDA PHARMACEUTICALS AMERICA, INC.
Application holderTAKEDA PHARMACEUTICALS USA INC
FDA applicationNDA213976 (NDA)
Labeler code64764
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio154 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 119 words ▾

1 INDICATIONS AND USAGE EOHILIA ™ is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks [see Dosage and Administration (2.1) , Clinical Studies (14) ]. EOHILIA is a corticosteroid indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).

( 1 ) Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. ( 1 , 2.1 , 14 )

⏱️ Dosage and Administration 183 words ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage : 2 mg orally twice daily for 12 weeks. ( 2.1 ) See full prescribing information for preparation and important administration instructions. ( 2.2 )

2.1Recommended Dosage The recommended dosage is 2 mg orally twice daily for 12 weeks.

2.2Preparation and Important Administration Instructions Do NOT take EOHILIA with food or liquid at the time of ingestion. Wait for at least 30 minutes to eat or drink after taking EOHILIA. Administer EOHILIA as follows: Do NOT mix EOHILIA with food or liquid.

Shake the EOHILIA packet for at least 10 seconds prior to opening . Squeeze the packet from the bottom to the top directly into the mouth. Repeat 2 to 3 times until the EOHILIA packet is empty .

Swallow all the EOHILIA suspension. Do not eat or drink for 30 minutes after taking EOHILIA. After 30 minutes, rinse mouth with water and spit out the contents without swallowing [see Warnings and Precautions (5.2) ] .

Avoid consumption of grapefruit juice for the duration of therapy with EOHILIA [see Drug Interactions (7.1) ] .

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral suspension: 2 mg/10 mL unit-dose packets of a white to yellow viscous suspension with cherry flavoring. Oral suspension: 2 mg/10 mL unit-dose packets. ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products [see Adverse Reactions (6.2) ] . Hypersensitivity to budesonide. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypercorticism and Adrenal Axis Suppression : May occur with treatment; monitor for signs and symptoms and consider reducing the dosage. ( 5.1 , 8.6 ) Immunosuppression and Increased Risk of Infection : Increased risk of viral, bacterial, fungal, protozoan, and helminthic infections, including potentially fatal varicella and measles infection. Monitor patients for new or worsening localized or systemic infection, including oropharyngeal and esophageal candidiasis and consider drug discontinuation.

Avoid use in patients with fungal infections, Strongyloides infestation, cerebral malaria, and ocular herpes simplex. Screen for hepatitis B infection. ( 5.2 ) Erosive Esophagitis : Advise patients or caregivers to report new or worsening signs or symptoms of erosive esophagitis; consider endoscopic evaluation as appropriate.

( 5.3 ) Effect on Growth : Use of corticosteroids may cause a reduction in growth velocity in pediatric patients; monitor growth during treatment. ( 5.4 ) Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids : Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). ( 5.5 ) Other Corticosteroid Effects : Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus).

( 5.6 ) Kaposi’s Sarcoma : Reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. ( 5.7 )

5.1Hypercorticism and Adrenal Axis Suppression Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including EOHILIA. Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression and consider reducing the dosage of EOHILIA [see Adverse Reactions (6.1) , Clinical Pharmacology (12.2) ]. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide.

Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended.

5.2Immunosuppression and Increased Risk of Infection Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor patients for the development of infection and consider discontinuation of EOHILIA if the patient develops an infection while on treatment. Tuberculosis If corticosteroids are used in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation while receiving EOHILIA. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune pediatric and adult patients taking corticosteroids. In corticosteroid-treated patients who have not had these diseases or are non-…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in other sections of the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] Immunosuppression and increased risk of infections [see Warnings and Precautions (5.2) ] Erosive esophagitis [see Warnings and Precautions (5.3) ] Effect on growth [see Warnings and Precautions (5.4) ] Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids [see Warnings and Precautions (5.5) ] Other corticosteroid effects [see Warnings and Precautions (5.6) ] Kaposi’s sarcoma [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) 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 EOHILIA in 410 adults and pediatric subjects 11 years of age and older with EoE was evaluated in two 12-week, double-blind, placebo-controlled studies (Study 1 and Study 2). In these studies, 263 subjects received EOHILIA [see Clinical Studies (14) ] .

Common Adverse Reactions The most common adverse reactions reported in Study 1 are shown in Table 1. Table 1: Common Adverse Reactions reported in at least 2% of subjects in the EOHILIA group and at a rate greater than placebo. in Adult and Pediatric Subjects 11 Years of Age and Older with EoE in Study 1 ADVERSE REACTIONS EOHILIA 2 mg Twice Daily N = 213 Placebo N = 105 Respiratory tract infection includes acute sinusitis, sinusitis, nasopharyngitis, respiratory tract infection, respiratory tract infection viral, upper respiratory tract infection, viral upper respiratory tract infection, rhinitis 13% 11% Gastrointestinal mucosal candidiasis includes esophageal candidiasis, oropharyngeal candidiasis, oral candidiasis 8% 2% Headache includes headache, migraine 5% 2% Gastroenteritis 3% 1% Throat irritation includes throat irritation, oropharyngeal pain 3% 2% Adrenal suppression includes adrenal suppression, adrenal insufficiency 2% 0 Erosive esophagitis includes esophagitis only where erosions were present at the esophagogastroduodenoscopy conducted after 12 weeks of treatment 2% 0 Specific Adverse Reactions Erosive Esophagitis Erosive esophagitis occurred in 4/213 (2%) of EOHILIA-treated subjects in Study 1.

These subjects had no erosions present at the baseline esophagogastroduodenoscopy (EGD). At EGD after 12 weeks of treatment with EOHILIA, 2 subjects had Los Angeles (LA) classification grade A, 1 subject had LA grade B, and 1 subject had LA grade C erosive esophagitis. All but one of the four subjects developed erosive esophagitis while receiving concomitant therapy with a PPI.

No cases of erosive esophagitis were reported in Study 2 [see Warnings and Precautions (5.3) ] . Less Common Adverse Reactions Adverse reactions reported in less than 2% of subjects treated with EOHILIA and at a greater rate than placebo in Study 1 are listed below: Cardiac disorders: Palpitations Gastrointestinal disorders: Dry mouth, dyspepsia, erosive duodenitis, gastrointestinal motility disorder, esophageal food impaction, palatal swelling General disorders and administration site conditions: Fatigue, feeling abnormal Infections and infestations: Fungal skin infection, paronychia, pneumonia, sepsis, bronchitis Investigations: Transaminases increased, hyperkalemia Metabolism and nutrition disorders: Dyslipidemia Musculoskeletal and connective tissue disorders: Arthralgia…

🔄 Drug Interactions 77 words ▾

7 DRUG INTERACTIONS CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations. Avoid concomitant use. ( 2.2 , 7.1 )

7.1CYP3A4 Inhibitors Budesonide is a substrate for CYP3A4. Concomitant use of budesonide with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice) can increase systemic budesonide concentrations [see Clinical Pharmacology (12.3) ] . Avoid concomitant use of CYP3A4 inhibitors, including grapefruit juice, with EOHILIA [see Dosage and Administration (2.2) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause fetal harm. ( 8.1 ) Hepatic Impairment: Use is not recommended in severe hepatic impairment. Monitor patients with moderate hepatic impairment for signs and/or symptoms of hypercorticism. ( 5.1 , 8.6 )

8.1Pregnancy Risk Summary The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal outcomes. Infants exposed to in-utero corticosteroids, including EOHILIA, are at risk for hypoadrenalism (see Clinical Considerations ) . In animal reproduction studies, subcutaneous administration of budesonide during organogenesis in pregnant rats (at doses up to approximately 1.2 times the maximum recommended human dose, based on body surface area [BSA]) or pregnant rabbits (at doses approximately 0.14 times the maximum recommended human dose, based on body surface area [BSA]) resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities.

Maternal toxicity was observed in both rats and rabbits at these dose levels (see Data ) . Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage in the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.

Infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see Warnings and Precautions (5.1) ] . Data Animal Data Budesonide was teratogenic and embryolethal in rabbits and rats. In an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis from gestation days 6-15, there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg/day in rats (approximately 1.2 times the maximum recommended human dose [MRHD], based on body surface area [BSA]).

In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses up to approximately 25 mcg/kg/day (approximately 0.14 times the MRHD, based on BSA). Maternal toxicity, including reduction in body weight gain, was observed at subcutaneous doses of 5 mcg/kg in rabbits (approximately 0.03 times the MRHD, based on BSA) and 500 mcg/kg in rats (approximately 1.2 times the MRHD, based on BSA).

In a peri- and post-natal development study, rats dosed subcutaneously with budesonide during the period of Day 15 post coitum to Day 21 postpartum, budesonide had no effects on delivery but did have an effect on growth and development of offspring. In addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures 0.05 times the MRHD (on a mg/m 2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity.

8.2Lactation Risk Summary Lactation studies have not been conducted with oral budesonide, including EOHILIA, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. One published study reported that budesonide is present in human milk following maternal inhalation of budesonide (see Data ) . The developmental and health benefits of breastfeeding…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal outcomes. Infants exposed to in-utero corticosteroids, including EOHILIA, are at risk for hypoadrenalism (see Clinical Considerations ) . In animal reproduction studies, subcutaneous administration of budesonide during organogenesis in pregnant rats (at doses up to approximately 1.2 times the maximum recommended human dose, based on body surface area [BSA]) or pregnant rabbits (at doses approximately 0.14 times the maximum recommended human dose, based on body surface area [BSA]) resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities.

Maternal toxicity was observed in both rats and rabbits at these dose levels (see Data ) . Based on animal data, advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage in the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.

Infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see Warnings and Precautions (5.1) ] . Data Animal Data Budesonide was teratogenic and embryolethal in rabbits and rats. In an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis from gestation days 6-15, there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg/day in rats (approximately 1.2 times the maximum recommended human dose [MRHD], based on body surface area [BSA]).

In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses up to approximately 25 mcg/kg/day (approximately 0.14 times the MRHD, based on BSA). Maternal toxicity, including reduction in body weight gain, was observed at subcutaneous doses of 5 mcg/kg in rabbits (approximately 0.03 times the MRHD, based on BSA) and 500 mcg/kg in rats (approximately 1.2 times the MRHD, based on BSA).

In a peri- and post-natal development study, rats dosed subcutaneously with budesonide during the period of Day 15 post coitum to Day 21 postpartum, budesonide had no effects on delivery but did have an effect on growth and development of offspring. In addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation at exposures 0.05 times the MRHD (on a mg/m 2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). These findings occurred in the presence of maternal toxicity.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of EOHILIA for 12 weeks of treatment for EoE have been established in pediatric patients 11 years of age and older. Use of EOHILIA for this indication is supported by adequate and well controlled studies in adults and pediatric subjects 11 years of age and older (Studies 1 and 2) with pharmacokinetic data in pediatric subjects aged 11 to 17 years of age. In Studies 1 and 2, the safety of EOHILIA in pediatric subjects 11 to 17 years of age was similar to the safety profile in adults [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including EOHILIA [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) , and Clinical Pharmacology (12.2) ] . Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA.

The recommended duration of treatment with EOHILIA is 12 weeks [see Dosage and Administration (2.1) ] . The safety and effectiveness of EOHILIA in pediatric patients less than 11 years of age have not been established. Juvenile Animal Toxicity Data In a juvenile rat study, budesonide was administered orally at doses of 0.05, 0.2, 0.6, and 1.5 mg/kg/day starting on postnatal day (PND) 22 for 91 consecutive days.

All of the effects noted were associated with the pharmacology of the drug and manifested in a dose related manner, typical of corticosteroids. These included decreased body weight gain, adrenal atrophy, and effects on bone (decreased cellularity and bone length) and lymphoid tissues (decreased cellularity). The no observed adverse effect level (NOAEL) in juvenile rats was determined to be the 0.05 mg/kg/day.

Plasma exposure (AUC) in rats at the NOAEL (0.05 mg/kg/day) was lower (approximately 0.8 times) than that in pediatric subjects (11 years to 17 years of age) at the MRHD. In a juvenile toxicity study in dogs, budesonide was orally administered at doses of 0.05, 0.2, and 0.6 mg/kg/day (starting at approximately 7 weeks of age) for 91 consecutive days. The observations were dose-related and consistent with corticosteroid treatment.

The effects included decreased body weight gain, distended abdomen and swelling associated with inguinal hernias, lymphocytic and leukocytic changes, adrenal atrophy, depletion in lymphoid organs (lymph nodes, spleen, thymus), and effects on skeletal development (decreased cellularity in bone marrow, bone growth, and skeletal muscle atrophy). The incidence and severity of the majority of the pharmacologically mediated effects decreased or resolved completely following the recovery period. A NOAEL could not be defined in juvenile dogs.

Plasma exposure (AUC) at the lowest dose tested (0.05 mg/kg/day) was lower (approximately 0.4 times) than that in pediatric subjects (11 years to 17 years of age) at the MRHD.

🧓 Geriatric Use 53 words ▾

8.5Geriatric Use Clinical studies of EOHILIA did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. In general, EOHILIA should be used with caution due to the potential for decreased hepatic function [see Warnings and Precautions (5.1) ] .

🆘 Overdosage 53 words ▾

10 OVERDOSAGE Treatment of acute overdosage consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy. Use of corticosteroids, such as EOHILIA, at excessive doses or for prolonged periods, increases the risk of systemic corticosteroid effects such as hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone. The precise mechanism of corticosteroid actions on inflammation in EoE is not known. Inflammation is an important component in the pathogenesis of EoE.

Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukocytes and cytokines) involved in allergic inflammation.

12.2Pharmacodynamics In Study 1, blood samples to detect cortisol levels (stimulated and unstimulated) were collected in the morning for all subjects [see Clinical Studies (14) ] . At baseline, 4% of EOHILIA-treated subjects and 5% of placebo-treated subjects had abnormal peak adrenocorticotropic hormone (ACTH)-stimulated serum cortisol values, with abnormal defined as ≤18 mcg/dL. After 12 weeks of treatment, 9% of EOHILIA-treated subjects and 3% of placebo-treated subjects had abnormal peak ACTH-stimulated serum cortisol values [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] .

12.3Pharmacokinetics Budesonide geometric mean (%CV) maximum plasma concentration (C max ) was 915 (59) pg/mL and area under the time concentration curve at 12 hours (AUC 0-12h ) was 5071 (58) pg•h/mL after repeated oral administration of EOHILIA 2 mg twice daily in adult subjects with EoE. Based on population pharmacokinetic analysis, there was no difference in pharmacokinetics between healthy adults and adult subjects with EoE. Absorption The median (range) time to reach budesonide peak plasma concentration (t max ) was 2 hours (range 0.5 to 4 hours) after oral administration of EOHILIA 2 mg twice daily in adult subjects with EoE.

Following repeated (twice daily) oral administration of EOHILIA, the systemic exposure of budesonide was increased dose proportionally in the dose range of 0.5 to 2 mg (0.25 times the recommended dose and up to the recommended dose). The oral bioavailability of budesonide in healthy subjects is estimated to be 14% under fasting state. Effect of Food A high-fat, high-calorie meal (800-1000 calories and approximately 50% fat) administered to healthy subjects increased the AUC of budesonide by 26% and decreased the C max by 13% following a single dose of EOHILIA compared to fasting conditions.

Median time to reach peak plasma concentration was delayed approximately 1 hour with the intake of a high-fat, high-calorie meal. The increase in systemic exposure of budesonide due to food effect is not expected to be clinically meaningful. Distribution The mean volume of distribution (V ss /F) of budesonide is 1886 L after repeated oral administration of EOHILIA.

Plasma protein binding was estimated to be 85% to 90% in the concentration range 0.43 to 99.02 ng/mL. The erythrocyte/plasma partition ratio at clinically relevant concentrations was about 0.8. Elimination Budesonide has a high plasma clearance, 0.9 to

1.8L/min approaching the estimated liver blood flow, suggesting that budesonide is a high hepatic clearance drug. The mean plasma elimination half-life (t 1/2 ) of budesonide after administration of EOHILIA was 3.3 hours. Metabolism Following oral absorption, budesonide is subject to high first pass metabolism (80% to 90%).

In vitro , budesonide is biotransformed, mainly by CYP3A4, to its 2 major metabolites, 6beta-hydroxy budesonide and 16alpha-hydroxy prednisolone. The corticosteroid activity of these metabolites was negligible (less than1/100) in relation to that of the parent compound. Excretion Budesonide is excreted in urine and feces in the form of metabolites.

After oral as well as intravenous administration of micronized [ 3 H]-budesonide, appr…

🧬 Mechanism of Action 102 words ▾

12.1Mechanism of Action Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone. The precise mechanism of corticosteroid actions on inflammation in EoE is not known. Inflammation is an important component in the pathogenesis of EoE.

Corticosteroids have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukocytes and cytokines) involved in allergic inflammation.

📦 How Supplied / Storage and Handling 63 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EOHILIA (budesonide oral suspension) 2 mg/10 mL is a white to yellow viscous suspension with cherry flavoring supplied in child-resistant unit-dose packets. EOHILIA is supplied in a carton containing 60 unit-dose packets (NDC 64764-105-60). Store refrigerated or at controlled room temperature at 2°C to 25°C (36°F to 77°F). Excursions up to 30°C (86°F) are acceptable. Do NOT freeze.

📋 Description 162 words ▾

11 DESCRIPTION EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22 R and 22 S ).

The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.53. Its structural formula is: Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension.

Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel ® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet ® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Hypercorticism and Adrenal Axis Suppression Advise the patient or caregiver that EOHILIA may cause hypercorticism and adrenal axis suppression and to report any signs or symptoms to their healthcare provider (e.g., acne, bruise easily, ankle swelling, thicker body hair and facial hair, pink or purple stretch marks, a fatty pad or hump between the shoulders, tiredness, weakness, nausea and vomiting, low blood pressure) [see Warnings and Precautions (5.1) ] .

Immunosuppression and Increased Risk of Infection Advise patients or caregivers to inform their healthcare provider if they develop a new or worsening infection and to contact their healthcare provider immediately if they are exposed to varicella or measles [see Warnings and Precautions (5.2) ] . Inform the patient or caregiver that localized infections with Candida albicans may occur in the mouth, throat, and esophagus. Instruct patients to rinse the mouth with water 30 minutes after administration of EOHILIA and to spit out the contents without swallowing.

Advise the patient or caregiver to contact the healthcare provider if the patient experiences signs or symptoms of oropharyngeal or esophageal candidiasis [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] . Erosive Esophagitis Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis (e.g., heartburn, chest pain, trouble swallowing) to their healthcare provider [see Warnings and Precautions (5.3) ] . Effect on Growth Advise patients or caregivers that corticosteroids can affect growth in pediatric patients and to report concerns regarding growth while taking EOHILIA to the healthcare provider [see Warnings and Precautions (5.4) ] .

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids If transferring to EOHILIA from corticosteroid treatment with high systemic effects, advise the patient or caregiver to follow a taper schedule for systemic corticosteroids, as instructed by the healthcare provider. Advise patients or caregivers that replacement of other systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the other drug [see Warnings and Precautions (5.5) ] .

Kaposi’s Sarcoma Advise patients or caregivers that Kaposi’s sarcoma has been reported in patients receiving corticosteroids for chronic conditions and to inform their healthcare provider if they experience signs or symptoms of Kaposi’s sarcoma [see Warnings and Precautions (5.7) ] . Pregnancy Advise female patients that EOHILIA may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1) ] . Administration Advise patients: Do NOT take EOHILIA with food or liquid at the time of ingestion.

Wait for at least 30 minutes to eat or drink after taking EOHILIA [see Clinical Pharmacology (12.3) ] . Administer EOHILIA as follows: Do NOT mix EOHILIA with food or liquid. Shake EOHILIA packet for at least 10 seconds prior to opening.

Squeeze the packet from the bottom to the top directly into the mouth. Repeat 2 to 3 times until the EOHILIA packet is empty. Swallow all the EOHILIA suspension.

Do not eat or drink for 30 minutes after taking EOHILIA. After 30 minutes, rinse mouth with water and spit out the contents without swallowing [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] . Avoid consumption of grapefruit juice for the duration of EOHILIA therapy [see Drug Interactions (7.1) ] .

Distributed by: Takeda Pharmaceuticals America, Inc. Cambridge, MA 02142 EOHILIA and are trademarks of ViroPharma Biologics LLC. TAKEDA and are registered trademarks of Takeda Pharmaceutical Company Limited. ©2025 Takeda Pharmaceuticals U.S.A., Inc.

All rights reserved. E…

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 pouches64764-0105-60 3,516 Rx · $6,459,351
10 pouches this page64764-0105-00 No Medicaid data
Drug total (last 4 qtrs): 3,516 Rx · 2,034,960 units · $6,459,351 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Eohilia — 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 Eohilia. 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
$1.2M
Claims incl. refills
583
Beneficiaries
406
Spend / beneficiary
$2,957.22
Spend / claim
$2,059.40
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 Eohilia (this brand).

Top reported reactions

Dyspnoea4,483
Asthma3,566
Fatigue2,541
Condition Aggravated2,426
Headache2,388
Diarrhoea2,316
Cough2,195

Age at onset

Neonate106
Infant80
Child475
Adolescent368
Adult4,600
Elderly2,920

Reporter sex

39,874 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization15,059
Death3,056
Life-threatening1,910
Disabling1,006
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,196 1,899
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 — 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 ✓ 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 TAKEDA PHARMACEUTICALS AMERICA, INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 pouches (64764-0105-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
TAKEDA PHARMACEUTICALS AMERICA, 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.
← 64764-0080-40 · Takeda 64764-0107-11 · Takeda →
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.