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Diazoxide 50 mg/mL Suspension

by Par Health USA, LLC · 1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER
NDC 00254-1010-19
🏷️ FDA NDC (as labeled) 0254-1010-19 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0254-1010-19
Product NDC 0254-1010
11-digit billing NDC 00254101019
NCPDP billing unit ML — per mL (volume)
RxCUI 197593
UNII O5CB12L4FN
UPC 0302541010198
Application # ANDA210799
SPL Set ID abe317a5-6c63-469c-89c8-9fedfe859c3d
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-21
Route ORAL
Dosage form SUSPENSION
Substance DIAZOXIDE
GCN Seq No 000298
GCN 01280
HICL code 000092
Ingredient (HICL) Diazoxide
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4G
Therapeutic class — specific (HIC3) Agents To Treat Hypoglycemia (Hyperglycemics)
AHFS code 68:22.92.00
AHFS class Antihypoglycemic Agents, Miscellaneous
FDB label name DIAZOXIDE 50 MG/ML ORAL SUSP
FDB brand name Diazoxide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0254-1010-19 — a 4-4-2 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 labeler segment → 00254-1010-19. 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 Thiazide derivatives class.

Drug family (ATC) Thiazide derivatives, Drugs for treatment of hypoglycemia
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.

🏭 Manufacturer & labeler

LabelerPar Health USA, LLC
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA210799 (ANDA)
Labeler code00254
First marketedJul 2020
Product typeHuman Prescription Drug
Portfolio212 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.

🩺 Clinical

Label name DIAZOXIDE 50 MG/ML ORAL SUSP Ingredient Diazoxide
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.

💊 What it looks like

FlavorChocolate
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • 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 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

13 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 DailyMedingredient 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.

💲 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 $7.145 $214.35 / 30 ml
Medicaid paysCMS SDUD · 12 mo $7.23 $216.80 / 30 ml
Medicare drug plans payPart D · Q2 2026 $8.07 $242.08 / 30 ml
NADAC price history (per mL) — tap or hover for the price & month
Mar 2021 Dec 2025 Apr 2026 Aug 2026 $8.555 $6.669
▼ Down 11% over the last 12 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diazoxide 50 mg/mLthis 00254-1010-19 Par 1 bottle $7.145 AB Availability likely
Diazoxide 50 mg/mL 13517-0100-30 e5 1 bottle $7.145 AB Availability likely
Proglycem 50 mg/mL 00575-6200-30 Teva 1 bottle $16.483 AB Availability likely +131%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00254-1010-19, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.2K
Units reimbursed last 4 qtrs
123.5K
Gross reimbursed last 4 qtrs
$892.4K
Avg / prescription
$764.67
Avg / unit
$7.2267
Latest quarter Q4 2025
312Rx
Medicaid pays / mL
$7.2267
gross reimbursed
vs
NADAC / mL
$7.1450
acquisition cost
=
Spread
+$0.0817
+1% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
42% FFS 58% MCO
Fee-for-service · 495 Rx Managed care · 672 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 2,820 units · 36.1 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 33,172 units · 169 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 7,415 units · 59.1 per 100k residents IL Indiana: 15,326 units · 223 per 100k residents IN Ohio: no data reported OH Pennsylvania: 18,859 units · 146 per 100k residents PA New Jersey: 4,305 units · 46.3 per 100k residents NJ Massachusetts: no data reported MA California: 14,679 units · 37.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 560 units · 9.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 8,965 units · 82.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 6,274 units · 56.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 11,109 units · 36.4 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
9.1223
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 223 /100k
2 New York 169 /100k
3 Pennsylvania 146 /100k
4 North Carolina 82.7 /100k
5 Illinois 59.1 /100k
6 Georgia 56.9 /100k
7 New Jersey 46.3 /100k
8 California 37.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Diazoxide — the program that covers self-administered drugs. 2 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 Diazoxide. 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
$803.3K
Claims incl. refills
779
Beneficiaries
383
Spend / beneficiary
$2,097.31
Spend / claim
$1,031.16
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 Diazoxide — the ingredient across all brands.

Top reported reactions

Oedema Peripheral121
Hypoglycaemia99
Weight Increased81
Hyperglycaemia78
Oedema73
Peripheral Swelling73
Blood Glucose Increased72

Age at onset

Neonate37
Infant29
Child23
Adolescent2
Adult45
Elderly21

Reporter sex

1,254 reports
Male · 49%
Female · 51%
Unknown · 1%

Serious outcomes

Hospitalization379
Death104
Life-threatening87
Disabling9
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 376 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00254-1010-19 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER 2020-07-21 Active

📄 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 110 words

INDICATIONS & USAGE Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide oral suspension may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.

Diazoxide oral suspension should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with diazoxide oral suspension should be considered.

⏱️ Dosage and Administration 208 words

DOSAGE & ADMINISTRATION Patients should be under close clinical observation when treatment with diazoxide oral suspension is initiated. Carefully monitor the clinical response and blood glucose until the patient’s condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of diazoxide oral suspension is not effective after 2 or 3 weeks, discontinue diazoxide oral suspension.

Individualize the dosage of diazoxide oral suspension based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. Adjust the dosage until the desired clinical and laboratory effects are produced with the least amount of diazoxide oral suspension. Take special care to ensure the accuracy of the dosage in infants and young children.

Adults and children : The recommended starting dosage is 3 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 8 mg/kg/day. Patients with refractory hypoglycemia may require higher dosages.

Infants and newborns : The recommended starting dosage is 8 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 15 mg/kg/day.

Contraindications 25 words

CONTRAINDICATIONS Diazoxide oral suspension is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in diazoxide oral suspension, or other thiazides

⚠️ Warnings ~1 min read

WARNINGS The antidiuretic property of diazoxide may lead to significant fluid retention. In patients with compromised cardiac reserve, fluid retention may precipitate congestive heart failure. If fluid retention develops, manage according to standards of care.

Co-administration of diazoxide oral suspension with thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (see DRUG INTERACTIONS and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with diazoxide oral suspension, usually during intercurrent illness. Prompt recognition and treatment are essential (see OVERDOSAGE), and prolonged surveillance following the acute episode is necessary because of the long drug half-life of approximately 30 hours.

Advise patients to monitor urine glucose and ketones and to promptly report abnormal findings and symptoms of ketoacidosis to their healthcare provider. Transient cataracts occurred in association with hyperosmolar coma in an infant, and subsided on correction of the hyper-osmolarity. Cataracts have been observed in several animals receiving daily dosages of intravenous or oral diazoxide.

The development of abnormal facial features in four children treated chronically (>4 years) with diazoxide oral suspension for hypoglycemia hyperinsulinism in the same clinic has been reported. Pulmonary Hypertension in Neonates and Infants There have been postmarketing reports of pulmonary hypertension occurring in infants and neonates treated with diazoxide. The cases were reversible upon discontinuation of diazoxide.

Monitor patients, especially those with risk factors for pulmonary hypertension, for respiratory distress and discontinue diazoxide oral suspension if pulmonary hypertension is suspected.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Frequent and Serious : Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. (see DRUG INTERACTIONS ). Infrequent but Serious : Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly.

Monitor patients for up to 7 days due to the long half-life of diazoxide (see OVERDOSAGE ). Other frequent adverse reactions : Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of diazoxide oral suspension.

Hyperglycemia or glycosuria may require reduction in dosage in order to avoid progression to ketoacidosis or hyperosmolar coma. Gastrointestinal intolerance may include anorexia, nausea, vomiting, abdominal pain, ileus, diarrhea, transient loss of taste. Tachycardia, palpitations, increased levels of serum uric acid are common.

Thrombocytopenia with or without purpura may require discontinuation of diazoxide oral suspension. Neutropenia is transient, is not associated with increased susceptibility to infection, and ordinarily does not require discontinuation of diazoxide oral suspension. Skin rash, headache, weakness, and malaise may also occur.

Other adverse reactions : Cardiovascular : Hypotension occurs occasionally, which may be augmented by thiazide diuretics given concurrently. A few cases of transient hypertension, for which no explanation is apparent, have been noted. Chest pain has been reported rarely.

Pulmonary hypertension has been reported in neonates and young infants (see WARNINGS ). There have been postmarketing reports of pericardial effusion in patients without structural heart disease; the majority of cases occurred in pediatric patients and infants. Gastrointestinal : There have been postmarketing reports of necrotizing enterocolitis; the majority of cases occurred in infants with underlying co-morbid conditions.

Hematologic : eosinophilia; decreased hemoglobin / hematocrit; excessive bleeding, decreased IgG. Hepato-renal : increased AST, alkaline phosphatase; azotemia, decreased creatinine clearance, reversible nephrotic syndrome, decreased urinary output, hematuria, albuminuria. Neurologic: anxiety, dizziness, insomnia, polyneuritis, paresthesia, pruritus, extrapyramidal signs.

Ophthalmologic : transient cataracts, subconjunctival hemorrhage, ring scotoma, blurred vision, diplopia, lacrimation. Skeletal, integumentary; monilial dermatitis, herpes, advance in bone age; loss of scalp hair. Systemic: fever, lymphadenopathy.

Other; gout acute pancreatitis/pancreatic necrosis, galactorrhea, enlargement of lump in breast.

🔄 Drug Interactions 79 words

DRUG INTERACTIONS Since diazoxide is highly bound to serum proteins, it may displace other substances which are also bound to protein, such as bilirubin or coumarin and its derivatives, resulting in higher blood levels of these substances. Concomitant administration of diazoxide oral suspension and diphenylhydantoin may result in a loss of seizure control. Consider these potential interactions when administering diazoxide oral suspension.

The concomitant administration of thiazides or other diuretics may potentiate the hyperglycemic and hyperuricemic effects of diazoxide.

🔄 Drug / Laboratory Test Interactions 46 words

DRUG & OR LABORATORY TEST INTERACTIONS The hyperglycemic and hyperuricemic effects of diazoxide preclude proper assessment of these metabolic states. Increased renin secretion, IgG concentrations and decreased cortisol secretions have also been noted. Diazoxide inhibits glucagon-stimulated insulin release and causes a false-negative insulin response to glucagon.

🧒 Pediatric Use 6 words

PEDIATRIC USE See INDICATIONS AND USAGE.

🆘 Overdosage 68 words

OVERDOSAGE An overdosage of diazoxide oral suspension causes marked hyperglycemia which may be associated with ketoacidosis. Because of the diazoxide’s long half-life (approximately 30 hours), the symptoms of overdosage require prolonged surveillance for periods up to 7 days until the blood glucose level stabilizes within the normal range. One investigator reported successful lowering of diazoxide blood levels by peritoneal dialysis in one patient and by hemodialysis in another.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Diazoxide produces a dose-related increase in blood glucose, due primarily to an inhibition of insulin release from the pancreas, and also to an extrapancreatic effect. The hyperglycemic effect of diazoxide begins within an hour and generally lasts no more than 8 hours in the presence of normal renal function. Diazoxide decreases the excretion of sodium and water, resulting in fluid retention which may be clinically significant.

The hypotensive effect of diazoxide is usually not marked (see ADVERSE REACTIONS ). Other pharmacologic actions of diazoxide include increased pulse rate; increased serum uric acid levels due to decreased excretion; increased serum levels of free fatty acids’ decreased chloride excretion; decreased para-aminohippuric acid; (PAH) clearance with no appreciable effect on glomerular filtration rate. The concomitant administration of a benzothiazide diuretic may intensify the hyperglycemic and hyperuricemic effects of diazoxide.

In the presence of hypokalemia, hyperglycemic effects are also potentiated. Diazoxide-induced hyperglycemia is reversed by the administration of insulin or tolbutamide. The inhibition of insulin release by diazoxide is antagonized by alpha-adrenergic blocking agents.

Diazoxide is extensively bound (more than 90%) to serum proteins, and is excreted in the kidneys. The plasma half-life following intravenous administration is 28 ± 8.3 hours. Limited data on oral administration revealed a half-life of 24 and 36 hours in two adults.

In four children aged 4 months to 6 years, the plasma half-life varied from 9.5 to 24 hours on long-term oral administration. The half-life may be prolonged following overdosage, and in patients with impaired renal function.

📦 How Supplied / Storage and Handling 109 words

HOW SUPPLIED Diazoxide Oral Suspension, USP 50 mg/mL, a white to light brown colored, chocolate-mint flavored suspension; bottle of 30 mL (NDC 0254-1010-19), with dropper calibrated to deliver 10, 20, 30, 40 and 50 mg diazoxide, USP. Shake well before each use. Protect from light.

Store in carton until contents are used. Store in light resistant container as defined in the USP. Store Diazoxide Oral Suspension, USP at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).

See USP Controlled Room Temperature. Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Manufactured for: Par Health USA Rochester, MI 48307 Revised : 07/2026 OS1010-01-16-06

📋 Description 122 words

DESCRIPTION Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%. Other ingredients include sorbitol solution, chocolate mint type flavor, propylene glycol, magnesium aluminum silicate, carboxymethylcellulose sodium, sodium benzoate, methylparaben, poloxamer 188, propylparaben, FD&C Red No.

40, FD&C Yellow No. 6 and purified water. Hydrochloric acid may be added to adjust pH.

Diazoxide has the following structural formula: Diazoxide is 7-chloro-3-methyl-2H-1,2,4-benzothiadiazine 1,1-dioxide with the empirical formula C 8 H 7 ClN 2 O 2 S and the molecular weight 230.7. It is a white powder practically insoluble to sparingly soluble in water. structure

💬 Information for Patients 92 words

INFORMATION FOR PATIENTS Advise patients of the need for periodic laboratory testing during treatment with diazoxide oral suspension. In addition, advise patients to: take diazoxide oral suspension on a regular schedule as prescribed, not to skip doses, not to take extra doses consult their healthcare provider before starting any new medications not allow anyone else to take this medication follow dietary instructions report any adverse reactions (i.e., increased urinary frequency, increased thirst, fruity breath odor) promptly to their healthcare provider report pregnancy or to discuss plans for pregnancy with their healthcare provider

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