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Khindivi Hydrocortisone 1 mg/mL Solution, 1 mL — NDC 71863-116-16 (Billing 71863-0116-16)

by Eton Pharmaceuticals, Inc. · 1 mL in 1 BOTTLE

This is a package of 1 mL of Khindivi Hydrocortisone 1 mg/mL Solution from Eton Pharmaceuticals, Inc., marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 71863-0116-16
🏷️ FDA NDC (as labeled) 71863-116-16 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

NDC database record

One package, one record: these facts belong to NDC 71863-116-16 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71863 labeler · 116 product · 16 package
Package marketed since
Jun 2, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
1 mL per package
Barcode (UPC)
0371863116161
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71863-116-16
Product NDC 71863-116
11-digit billing NDC 71863011616
NCPDP billing unit ML — per mL (volume)
RxCUI 2716550, 2716556
UNII WI4X0X7BPJ
UPC 0371863116161
Application # NDA218980
SPL Set ID 1ef80500-8386-40ee-b608-516cd687b376
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 2025-06-02
Route ORAL
Dosage form SOLUTION
Substance HYDROCORTISONE

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

GPI-14 22100025002020
GCN Seq No 087785
GCN 57805
HICL code 002867
Ingredient (HICL) Hydrocortisone
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 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name KHINDIVI 1 MG/ML SOLUTION
FDB brand name Khindivi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087785
  • GCN: 57805
  • GPI-14 (Medi-Span): 22100025002020
  • HICL (First Databank): 002867
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 2716550
Why two NDCs? The FDA registers this code as 71863-116-16 — 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 → 71863-0116-16. 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, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
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 KHINDIVI 1 MG/ML SOLUTION Ingredient Hydrocortisone
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →
8
Nutrient depletion considerations

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

🧪 Full Hydrocortisone 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 $26.53 $26.53 / 1 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 Marketing startMarketing endStatus
71863-0116-16 You're viewing this Main listing 1 mL in 1 BOTTLE 2025-06-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Khindivi 1 mg/mLthis 71863-0116-16 Eton 1 ml — — 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

🏛️
2025
First FDA approval
May 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2043
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 Feb 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 28, 2025 RLD RS ⏳ ~16.4 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 12133914 — method of use (U-4215)
US 11904046 — method of use (U-4216)
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (2)
PatentTypeUse codeExpires
US 12133914 ↗ Method of use U-4215 Feb 23, 2043
US 11904046 ↗ Method of use U-4216 Feb 23, 2043
Common questions
Is there a generic version of KHINDIVI 1 MG/ML SOLUTION?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for KHINDIVI 1 MG/ML SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2043 — 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.

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

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

  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII L6Q8K29L05
    A sweet-smelling organic compound used in medicines as a flavor enhancer and fragrance agent. It strengthens or improves the taste and aroma of liquid or solid formulations.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

8 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

LabelerEton Pharmaceuticals, Inc.
Application holderETON PHARMACEUTICALS INC
FDA applicationNDA218980 (NDA)
Labeler code71863
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Eton Pharmaceuticals, Inc. labeler code 71863

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 111 words ▾

1 INDICATIONS AND USAGE KHINDIVI is indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. KHINDIVI is a corticosteroid indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency. ( 1 ) Limitations of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events.

Use a different hydrocortisone-containing drug product for stress dosing [see Warnings and Precautions (5.1) ] . Limitations of Use KHINDIVI is not approved for increased dosing during periods of stress or acute events. Use a different hydrocortisone-containing drug product for stress dosing [(see Warnings and Precautions (5.1) ] .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Individualize the dose, using the lowest possible dosage. ( 2.1 ) When stress dosing is needed use a different hydrocortisone containing drug product. ( 2.1 ) The recommended starting replacement dosage of KHINDIVI is 8 to 10 mg/m 2 daily.

Higher doses may be needed based on the patient's age and symptoms of the disease. Use of lower starting doses may be sufficient in patients with residual but decreased endogenous cortisol production. ( 2.2 ) Divide the total daily dose into 3 doses and administer 3 times daily.

Older patients may have their daily dose divided by 2 and administered twice daily. ( 2.2 ) KHINDIVI contains the inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin. If patients experience adverse reactions (i.e., hyperosmolarity, metabolic acidosis, hypoglycemia, hepato-renal injury, central nervous system toxicity, and gastrointestinal adverse reactions), consider discontinuation of KHINDIVI and switch to another hydrocortisone product.

( 2.3 ) When switching from other oral hydrocortisone formulations, use the same total daily hydrocortisone dosage. If symptoms of adrenal insufficiency occur, increase total daily dosage. ( 2.4 ) See the Full Prescribing Information for detailed dosing and administration instructions.

( 2 )

2.1Important Considerations for Dosing Individualize the dose for each patient, using the lowest possible dosage. Monitor patients for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth, and weight gain. Adjust doses accordingly.

When stress dosing is needed (during episodes of acute febrile illness, gastroenteritis, surgery or major trauma) use a different hydrocortisone-containing drug product. [see Warnings and Precautions (5.1) ] .

2.2Recommended Dosage and Administration The recommended starting replacement dosage of KHINDIVI is 8 to 10 mg/m 2 daily administered orally with or without food. Higher doses may be needed based on the patient's age and symptoms of the disease. Use of lower starting dose may be sufficient in patients with residual but decreased endogenous cortisol production.

Round the dose to the nearest 0.5 mg or 1 mg. Divide the total daily dose into 3 doses and administer 3 times daily. Older pediatric patients may have their daily dose divided by 2 and administered twice daily.

Administer KHINDIVI using the oral syringe provided by the pharmacy. KHINDIVI may be administered through a gastric tube. Flush gastric tube with 20 mL of water to ensure the entire dose is delivered.

2.3Discontinue KHINDIVI Due to Adverse Reactions Associated with Inactive Ingredients KHINDIVI contains the inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin, which have been associated with hyperosmolarity, metabolic acidosis, hypoglycemia, hepato-renal injury, central nervous system toxicity, and gastrointestinal adverse reactions. If patient presents with adverse reactions that could be related to these conditions, monitor the patient, and consider discontinuation of KHINDIVI and switching to another hydrocortisone product [see Warnings and Precautions (5.2) ] .

2.4Switching to KHINDIVI from Other Oral Hydrocortisone Formulations When switching patients to KHINDIVI from other oral hydrocortisone formulations to KHINDIVI use the same total daily hydrocortisone dosage. After switching to KHINDIVI, monitor patients for symptoms of adrenocortical insufficiency. If symptoms of adrenal insufficiency occur after switching, increase the total daily dosage of KHINDIVI [see Dosage and Administration (2.2) and Warnings and Precautions (5.1 , 5.2) ].

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS KHINDIVI oral solution, 1 mg/mL is a clear, colorless to slightly yellow colored viscous oral solution. Oral solution: 1 mg/mL. ( 3 )

⛔ Contraindications 42 words ▾

4 CONTRAINDICATIONS KHINDIVI is contraindicated in patients with hypersensitivity to hydrocortisone or to any component of KHINDIVI. Reactions have included anaphylaxis in patients receiving corticosteroids [see Adverse Reactions (6.2) ] . Hypersensitivity to hydrocortisone or any component of KHINDIVI. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Adrenal Crisis : Undertreatment, sudden discontinuation of therapy, or switching from another oral hydrocortisone formulation may lead to adrenocortical insufficiency, adrenal crisis and death. Adrenal crisis may also be induced by stress events such as infections or surgery. During periods of stress switch to another oral hydrocortisone product and increase the dose.

Switch patients who are vomiting, severely ill or unable to take oral medications to parenteral corticosteroid formulations. ( 5.1 ) Systemic Adverse Reactions Due to Inactive Ingredients : KHINDIVI contains the inactive ingredients polyethylene glycol 400, propylene and glycol, and glycerin, which may cause hyperosmolarity, metabolic acidosis, hypoglycemia, hepato-renal injury, central nervous toxicity, gastrointestinal adverse reactions. Discontinue KHINDIVI and switch to another hydrocortisone product if these adverse reactions occur.

( 5.2 ) Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement : Use of a greater than replacement dosage can suppress the immune system and increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. ( 5.3 ) Growth Retardation : Long-term use in excessive doses may cause growth retardation.

Use the minimum dosage of KHINDIVI to achieve desired clinical response and monitor the patient's growth. ( 5.4 ) Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids : Prolonged use with supraphysiologic doses may cause Cushing's syndrome. Monitor patients for signs and symptoms of Cushing's syndrome every 6 months.

( 5.5 ) Decrease in Bone Mineral Density : Corticosteroids decrease bone formation and increase bone resorption which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of KHINDIVI to achieve desired clinical response.( 5.6 ) Psychiatric Adverse Reactions : Use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations and delirium or depression. Symptoms typically emerge within a few days or weeks of starting the treatment.

Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.

( 5.7 ) Ophthalmic Adverse Reactions : Cataracts, glaucoma and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances and if they occur, refer them to an ophthalmologist. ( 5.8 ) Gastrointestinal Adverse Reactions : Increased risk in patients with certain gastrointestinal disorders.

Signs and symptoms may be masked. ( 5.9 )

5.1Adrenal Crisis Undertreatment with KHINDIVI or sudden discontinuation of therapy with KHINDIVI may lead to adrenocortical insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events such as infections or surgery when patients require higher doses of corticosteroids. Symptoms of adrenocortical insufficiency include poor feeding, fatigue, low muscle tone, joint pain, nausea, vomiting, hypoglycemia, low blood pressure and electrolyte disturbances.

During periods of stress (e.g., infections, surgery), switch to another oral hydrocortisone product and increase the dose, if oral medications are tolerated. Switch patients who are vomiting, severely ill, or unable to take oral medications to parenteral corticosteroid formulations without delay. Once the patient recovers, gradually reduce the steroid dosage used during the acute event and do not switch back to KHINDIVI until the maintenance dosage can be resumed.

KHINDIVI is not approved for stress dosing. KHI… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Adrenal Crisis [see Warnings and Precautions (5.1) ] Systemic Adverse Reactions Due to Inactive Ingredients [see Warnings and Precautions (5.2) ] Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions (5.3) ] Growth Retardation [see Warnings and Precautions (5.4) ] Cushing's Syndrome Due to Use of Excessive Doses of Corticosteroids [see Warnings and Precautions (5.5) ] Decrease in Bone Mineral Density [see Warnings and Precautions (5.6) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] Ophthalmic Adverse Reactions [see Warnings and Precautions (5.8) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.9) ] Risk of Kaposi's Sarcoma with Use of Dosage Greater than Replacement [see Warnings and Precautions (5.10) ] Vaccinations [see Warnings and Precautions (5.11) ] Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies 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 oral hydrocortisone was evaluated in an uncontrolled, open-label, single-arm clinical study in 18 pediatric patients with adrenocortical insufficiency treated with oral hydrocortisone granules. Adrenocortical insufficiency was due to congenital adrenal hyperplasia in 17 patients and to hypopituitarism in one patient.

All patients received at least one dose of hydrocortisone granules. The age ranged from 36 days to 5.7 years at start of treatment; 8 patients were female and 10 were male; 100% were White. Adverse reactions that were reported in two or more patients (≥ 11%) are shown in Table 1.

Table 1: Adverse Reactions Occurring in ≥11% of Pediatric Patients with Adrenocortical Insufficiency Treated with Hydrocortisone Granules for up to 29 Months Adverse Reactions N=18 n (%) Pyrexia 10 (56) Gastroenteritis 9 (50) Viral upper respiratory tract infection 8 (44) Vomiting 7 (39) Viral infection 6 (33) Conjunctivitis 5 (28) Otitis media viral 3 (17) Tonsillitis 3 (17) Body temperature increased 2 (11) Bronchitis 2 (11) Dental caries 2 (11) Diarrhea 2 (11) Genitourinary operation 2 (11) Pharyngitis 2 (11) Respiratory tract infection 2 (11) Rhinitis 2 (11)

6.2Postmarketing Experience The following adverse reactions seen in pediatric and adult patients associated with the use of corticosteroids were identified in the literature and from postmarketing reports. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Allergic Reactions: Anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increa… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 2: Drug Interactions with KHINDIVI CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of KHINDIVI and increase the risk of adverse reactions associated with the use of excessive doses. Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the KHINDIVI dose.

Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin Antiretrovirals: ritonavir Grapefruit juice CYP3A4 Inducers Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of KHINDIVI and increase the risk of adverse reactions, including adrenal crisis. Intervention: Concomitant use of CYP3A4 inducers may require an increase in the KHINDIVI dose.

Examples: Anticonvulsants : phenytoin, carbamazepine and oxcarbazepine Antibiotics : rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals : efavirenz and nevirapine Estrogen and Estrogen-Containing Products Clinical Impact: Oral estrogen and estrogen-containing oral contraceptives may interact with hydrocortisone by increasing serum cortisol-binding globulin (CBG) concentration. Concomitant use may reduce the efficacy of KHINDIVI by binding and delaying or preventing absorption. Intervention: Concomitant use of estrogen/estrogen containing products may require an increase in the KHINDIVI dose.

Antidiabetic Agents Clinical Impact: Corticosteroids in supraphysiologic doses may increase blood glucose concentrations. Intervention: Use of KHINDIVI in supraphysiologic doses may require a dose adjustment of antidiabetic agents. Anticoagulant Agents Clinical Impact: Concomitant use of warfarin and corticosteroids usually results in inhibition of response to warfarin, although there have been some conflicting reports.

Intervention: Monitor coagulation indices in patients receiving KHINDIVI and concomitant warfarin to maintain the desired anticoagulant effect. Cyclosporine Clinical Impact: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with concurrent use.

Intervention: Monitor patients receiving KHINDIVI and concomitant cyclosporine. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Clinical Impact: Concomitant use of NSAIDs and corticosteroids increases the risk of gastrointestinal adverse reactions. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Intervention: Monitor patients receiving KHINDIVI and concomitant NSAIDs. CYP3A4 Inhibitors : concomitant administration may require a decrease in the KHINDIVI dose.

( 7 ) CYP3A4 Inducers : concomitant administration may require an increase in the KHINDIVI dose. ( 7 ) Estrogen and Estrogen-Containing Products : concomitant administration may require an increase in the KHINDIVI dose. ( 7 ) Antidiabetic agents : excessive doses may increase blood glucose concentrations.

Dose adjustment of antidiabetic agents may be required. ( 7 ) NSAIDs : concomitant administration increases risk of gastrointestinal adverse reactions. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. The use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. However, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications.

In addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore limits fetal exposure. Animal Data Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring.

8.2Lactation Risk Summary Cortisol is present in human milk. The use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. There are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for KHINDIVI and any potential adverse effects on the breastfed infant from KHINDIVI or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of KHINDIVI have been established in pediatric patients 5 years of age and older for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. Use of KHINDIVI for this indication is supported by findings of safety and efficacy in other approved hydrocortisone products, including supportive pharmacokinetic and safety data in pediatric patients with adrenocortical insufficiency. KHINDIVI is not approved in pediatric patients less than 5 years of age.

KHINDIVI contains the inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin, which undergo substantial systemic absorption. These inactive ingredients, individually or in combination, may increase plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age due to incomplete alcohol dehydrogenase maturity [see Warnings and Precautions (5.2) ]. When prescribing KHINDIVI in pediatric patients 5 years of age and older, consider the combined daily amount of polyethylene glycol 400, propylene glycol, and glycerin from all sources including KHINDIVI and other drugs with inactive ingredients utilizing the same metabolic pathways as these inactive ingredients, which may increase exposure and lead to an increased risk… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. The use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. However, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders, such as underlying maternal disease and use of concomitant medications.

In addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore limits fetal exposure. Animal Data Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring.

🧒 Pediatric Use 201 words ▾

8.4Pediatric Use The safety and effectiveness of KHINDIVI have been established in pediatric patients 5 years of age and older for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. Use of KHINDIVI for this indication is supported by findings of safety and efficacy in other approved hydrocortisone products, including supportive pharmacokinetic and safety data in pediatric patients with adrenocortical insufficiency. KHINDIVI is not approved in pediatric patients less than 5 years of age.

KHINDIVI contains the inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin, which undergo substantial systemic absorption. These inactive ingredients, individually or in combination, may increase plasma osmolarity in all pediatric patients, especially in pediatric patients less than 5 years of age due to incomplete alcohol dehydrogenase maturity [see Warnings and Precautions (5.2) ]. When prescribing KHINDIVI in pediatric patients 5 years of age and older, consider the combined daily amount of polyethylene glycol 400, propylene glycol, and glycerin from all sources including KHINDIVI and other drugs with inactive ingredients utilizing the same metabolic pathways as these inactive ingredients, which may increase exposure and lead to an increased risk of systemic toxicity [see Warnings and Precautions (5.2) ] .

🆘 Overdosage 12 words ▾

10 OVERDOSAGE Treatment of acute overdosage is by supportive and symptomatic therapy.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Hydrocortisone is a glucocorticoid. Glucocorticoids, adrenocortical steroids, cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

12.2Pharmacodynamics Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

12.3Pharmacokinetics Absorption Following oral administration of KHINDIVI (5 mg) in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) maximum plasma concentration (C max ) of hydrocortisone is 152 (98-210) ng/mL. Mean (range) time to reach maximum concentration (T max ) is 0.5 (0.25-0.75) hours. Effect of Food No clinically significant differences in KHINDIVI pharmacokinetics were observed following administration of a high-fat meal.

Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein. The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.

Following administration of 5 mg Hydrocortisone oral solution in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) apparent (oral) volume of distribution (Vd/F) of hydrocortisone is 23 (5-59) L. Elimination Hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

Following administration of 5 mg Hydrocortisone oral solution in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) terminal half-life of hydrocortisone is about 0.95 (0.3-2.3) hours.

🧬 Mechanism of Action 26 words ▾

12.1Mechanism of Action Hydrocortisone is a glucocorticoid. Glucocorticoids, adrenocortical steroids, cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING KHINDIVI is supplied as a colorless to slightly yellow colored, clear viscous solution: Strength Volume in Bottle NDC 1 mg/mL 473 mL 71863-116-16 Store at 2°C to 25°C (36°F to 77°F). Excursions permitted to 30°C (86°F) [see USP refrigerated and controlled room temperature]. Protect from light and heat.

Product must be used within 120 days of first opening. If not used within 120 days, the unused portion must be discarded.

📦 Storage and Handling 47 words ▾

Store at 2°C to 25°C (36°F to 77°F). Excursions permitted to 30°C (86°F) [see USP refrigerated and controlled room temperature]. Protect from light and heat. Product must be used within 120 days of first opening. If not used within 120 days, the unused portion must be discarded.

📋 Description 110 words ▾

11 DESCRIPTION KHINDIVI contains hydrocortisone, a corticosteroid, also known as cortisol. The chemical name of hydrocortisone is 11β,17α,21-trihydroxy-pregn-4-ene-3,20-dione and it has the chemical formula of C 21 H 30 O 5 , and molecular weight of 362 g∙mol –1 . Hydrocortisone is a white or almost white powder soluble in the pH range of 1-7.

Structural formula of hydrocortisone: KHINDIVI is a clear, colorless to slightly yellow colored viscous solution of hydrocortisone available for oral administration in a concentration of 1 mg/mL. The inactive ingredients are berry flavor, butylated hydroxyanisole, ethyl maltol, glycerin (623 mg/mL), methylparaben, propylparaben, polyethylene glycol 400 (500 mg/mL), propylene glycol (50 mg/mL), and sucralose. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide). Administration Information Instruct patients and/or caregivers to use an oral dosing syringe to correctly measure the prescribed amount of medication. Inform patients and/or caregivers that oral dosing syringes may be obtained from their pharmacy.

Advise patients and/or caregivers to take a sip of water immediately following administration to ensure all the solution has been swallowed. For administration through a gastric tube, flush with 20 mL of water to ensure that the entire dose is delivered [see Dosage and Administration (2.2) ]. Adrenal Crisis Inform patients and/or caregivers that undertreatment or sudden discontinuation of KHINDIVI or switching to KHINDIVI from another oral hydrocortisone formulation, may lead to adrenocortical insufficiency, adrenal crisis, and death.

Inform patients and/or caregivers to switch to another oral hydrocortisone product and increase the dose during periods of stress, and not to use KHINDIVI for increased dosing during period of stress or acute events due to increased risk of systemic and gastrointestinal adverse reactions. Inform the caregiver that potential dosing inaccuracy of the manipulated oral hydrocortisone formulation (e.g., split or crushed tablets, compounded formulations) may result in dosing differences when switching to KHINDIVI which may require dose adjustments.

Advise caregivers to watch the patient for symptoms of adrenocortical insufficiency during the days after switching to KHINDIVI. Inform patient and/or caregiver to contact their healthcare provider if they have symptoms of adrenocortical insufficiency, prolonged vomiting, are severely ill or are unable to take oral medications [see Warnings and Precautions (5.1) ] . Systemic Adverse Reactions Due to Inactive Ingredients Inform patients and/or caregivers that some inactive ingredients in KHINDIVI may increase the risk for hyperosmolarity, metabolic acidosis, loose stools, diarrhea, and other systemic adverse reactions, which may increase the risk of adrenal crisis.

Patients and/or caregivers should contact the healthcare provider if patients have altered mental status, abnormal urine output, or are severely ill [see Warnings and Precautions (5.2) ] . Immunosuppression and Increased Risk of Infections Advise patients and/or caregivers that greater than replacement dosage of corticosteroids can suppress the immune system and increase the risk of infections. Instruct patients and/or caregivers to contact their healthcare provider if they develop any infections [see Warnings and Precautions (5.3) ] .

Growth Retardation Discuss with caregivers that long-term use of corticosteroids in excessive doses may cause growth retardation in pediatric patients [see Warnings and Precautions (5.4) ] . Cushing's Syndrome Inform patients and/or caregivers that prolonged use of corticosteroids in supraphysiologic doses may cause Cushing's syndrome and that symptoms and signs include weight gain, decreased height velocity, hyperglycemia, hypertension, edema, easy bruising, muscle weakness, red round face, depression, or mood swings [see Warnings and Precautions (5.5) ].

Decrease in Bone Mineral Density Inform patients and/or caregivers that corticosteroids decrease bone formation and increase bone resorption that may lead to osteoporosis [see Warnings and Precautions (5.6) ] . Psychiatric Adverse Reactions Advise patients and/or caregivers that corticosteroid use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations or depression. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop [see Warnings and Precautions (5.7) ] .

Ophthalmic Adverse Reactions Inform patients and/or caregivers that ophthalmic effects such as cataract, glaucoma or central serous chorioretinopathy have been reported with prolonged use of hig… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 04/2026 Medication Guide KHINDIVI ™ (kɪn-dɪv-i) (hydrocortisone) oral solution Read this Medication Guide before you start giving KHINDIVI to your child, and each time your child gets a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your child's medical condition or treatment. What is the most important information I should know about KHINDIVI?

KHINDIVI may cause serious side effects, including : Adrenal gland problems . Not giving enough KHINDIVI, stopping KHINDIVI, or switching to KHINDIVI after taking another hydrocortisone medicine (the same class of medicines as KHINDIVI) by mouth, can cause serious and life-threatening adrenal gland problems including death. Do not stop giving KHINDIVI without talking to your healthcare provider.

Tell your healthcare provider if your child has any of these symptoms: loss of appetite fatigue weakness joint pain nausea vomiting low blood sugar feeling lightheaded or dizzy problems with body salt (electrolyte) levels Your healthcare provider will change the dose of KHINDIVI depending on your child's size. During episodes of acute infections, surgery, or major trauma, your healthcare provider may prescribe your child a different hydrocortisone medicine and increase the dose. If your child is vomiting, severely ill, or unable to take medicines by mouth, your healthcare provider may use corticosteroid medicines that are given directly into the bloodstream instead.

The amount of hydrocortisone in a dose of KHINDIVI may not be the same as in previous hydrocortisone medicines that your child takes by mouth if these oral hydrocortisone medicines have been changed (for example, crushed or compounded). When switching to KHINDIVI, your healthcare provider may need to prescribe a starting dose of KHINDIVI that is different from previous hydrocortisone medicines that your child may have been taking by mouth. Watch your child closely after being switched to KHINDIVI and contact your healthcare provider if your child has any symptoms of adrenal gland problems.

Your healthcare provider may need to change the dose of KHINDIVI. See " What are the possible side effects of KHINDIVI? " for more information about side effects. What is KHINDIVI?

KHINDIVI is a prescription medicine that contains a medicine hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids. Hydrocortisone is a synthetic version of the hormone cortisol.

Cortisol is made naturally by the adrenal glands in the body. KHINDIVI (hydrocortisone) is a man-made (synthetic) corticosteroid used to replace the body's cortisol when the adrenal glands do not make enough (adrenal insufficiency) in children from 5 to 17 years of age. Who should not take or be given KHINDIVI?

Do not give your child KHINDIVI if they: are allergic to hydrocortisone or any of the ingredients in KHINDIVI. See the end of this Medication Guide for a complete list of ingredients in KHINDIVI. have any reaction like swelling or shortness of breath after being given KHINDIVI. Get medical help right away and tell your healthcare provider as soon as possible as these can be signs of an allergic reaction.

What should I tell my healthcare provider before giving KHINDIVI? Before you give your child KHINDIVI, tell your healthcare provider about all of your child's medical conditions, including if they: are feeling unwell, or their body is under stress because of surgery or trauma. Your healthcare provider may prescribe your child a different hydrocortisone medicine for a short period of time. have a fever or infection. have nausea, vomiting, or diarrhea. are due for vaccinations.

Taking KHINDIVI should not stop your child from being vaccinated. Tell your healthcare provider when your child is due for vaccinations. are scheduled for surgery. cannot swallow medicines by mouth or are fed through a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 192 words ▾

12.3Pharmacokinetics Absorption Following oral administration of KHINDIVI (5 mg) in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) maximum plasma concentration (C max ) of hydrocortisone is 152 (98-210) ng/mL. Mean (range) time to reach maximum concentration (T max ) is 0.5 (0.25-0.75) hours. Effect of Food No clinically significant differences in KHINDIVI pharmacokinetics were observed following administration of a high-fat meal.

Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein. The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.

Following administration of 5 mg Hydrocortisone oral solution in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) apparent (oral) volume of distribution (Vd/F) of hydrocortisone is 23 (5-59) L. Elimination Hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

Following administration of 5 mg Hydrocortisone oral solution in dexamethasone-suppressed healthy adult volunteers under fasted conditions, mean (range) terminal half-life of hydrocortisone is about 0.95 (0.3-2.3) hours.

🧬 Pharmacodynamics 22 words ▾

12.2Pharmacodynamics Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

🧪 Nonclinical Toxicology 35 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted with hydrocortisone to evaluate carcinogenic or mutagenic potential. Corticosteroids have been shown to impair fertility in male rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 32 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted with hydrocortisone to evaluate carcinogenic or mutagenic potential. Corticosteroids have been shown to impair fertility in male rats.

📄 Package Label / Principal Display Panel 16 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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 Hydrocortisone (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Hydrocortisone. CMS lists 11 products for this generic; we show the highest-spend one. 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
$19.92M
Claims incl. refills
699.9K
Beneficiaries
529.9K
Spend / beneficiary
$37.60
Spend / claim
$28.47
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 Khindivi (this brand).

Top reported reactions

Fatigue5,919
Condition Aggravated5,454
Nausea4,998
Rash4,908
Diarrhoea4,449
Headache4,425
Pain4,422

Age at onset

Neonate332
Infant314
Child1,040
Adolescent683
Adult7,947
Elderly3,424

Reporter sex

66,647 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,426
Death9,794
Life-threatening8,648
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,429 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 — 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 Eton Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Eton Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71863-0115-18 · Eton 71863-0119-60 · Eton →
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.