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INZIRQO hydrochlorothiazide 10 mg/mL Powder, For Suspension, 80 mL — NDC 70954-0522-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

INZIRQO hydrochlorothiazide 10 mg/mL Powder, For Suspension, 80 mL — NDC 70954-522-10 (Billing 70954-0522-10)

by ANI Pharmaceuticals, Inc. · 80 mL in 1 BOTTLE

This is a package of 80 mL of INZIRQO hydrochlorothiazide 10 mg/mL Powder, For Suspension from ANI Pharmaceuticals, Inc., marketed since Jan 2025 and currently FDA-listed; retail pharmacies pay about $4.46 per mL (NADAC). It is this product's only package size.

NDC 70954-0522-10
🏷️ FDA NDC (as labeled) 70954-522-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70954-522-10
Product NDC 70954-522
11-digit billing NDC 70954052210
NCPDP billing unit ML — per mL (volume)
RxCUI 2704012, 2704018
UNII 0J48LPH2TH
UPC 0370954522102
Application # NDA219141
SPL Set ID 41aaea48-6c1b-42c8-a96f-5923d49dc934
Established class (EPC) Thiazide Diuretic
Physiologic effect Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-30
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance HYDROCHLOROTHIAZIDE

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

GPI-14 37600040001920
GCN Seq No 087177
GCN 56974
HICL code 003649
Ingredient (HICL) Hydrochlorothiazide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.20.00
AHFS class Thiazide Diuretics (24:36)
FDB label name INZIRQO 10 MG/ML ORAL SUSP
FDB brand name Inzirqo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087177
  • GCN: 56974
  • GPI-14 (Medi-Span): 37600040001920
  • HICL (First Databank): 003649
  • AHFS class code: 24:36.20.00
  • RxCUI (RxNorm): 2704012
Why two NDCs? The FDA registers this code as 70954-522-10 — 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 → 70954-0522-10. 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 Diuretic class.

Pharmacologic class Thiazide Diuretic
Drug family (ATC) Renin-inhibitors, Thiazides, plain
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 INZIRQO 10 MG/ML ORAL SUSP Ingredient Hydrochlorothiazide
📗 Our plain-language guide HelloPharmacist
  • It lowers high blood pressure, which helps reduce the risk of strokes and heart attacks. Some products, such as Inzirqo and the tablets, are also used for swelling from conditions...
  • Take it by mouth exactly as prescribed, usually once a day. For swelling, your prescriber may have you take it only some days of the week. Food slightly lowers absorption, so ask m...
  • Dizziness, lightheadedness when standing, stomach upset, headache and weakness are the usual ones. Stand up slowly, and be careful with alcohol since it can worsen dizziness. Use s...
  • Call for eye pain or sudden vision changes, severe rash or blistering, trouble breathing, severe stomach pain, yellow skin or eyes, or unusual bruising or infections. Also call for...
📖 Read our full Hydrochlorothiazide guide →
8
Nutrient depletion considerations

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

🧪 Full Hydrochlorothiazide 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 $4.462 $356.94 / 80 ml
Medicaid paysCMS SDUD · 12 mo $4.62 $369.68 / 80 ml
Medicare drug plans payPart D · Q2 2026 $4.88 $390.71 / 80 ml
NADAC price history (per mL) — tap or hover for the price & month
Feb 2026 May 2026 Jul 2026 Sep 2026 $4.462 $4.449
Flat over the last 7 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70954-0522-10 You're viewing this Main listing 80 mL in 1 BOTTLE 2025-01-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Inzirqo 10 mg/mLthis 70954-0522-10 ANI 80 ml $4.462 — Availability likely —
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
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 28, 2025 RLD RS ⏳ ~17.3 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 11878022 — method of use (U-4138)
US 11878022 — method of use (U-4139)
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 11878022 ↗ Method of use U-4138 Jan 23, 2044
US 11878022 ↗ Method of use U-4139 Jan 23, 2044
Common questions
Is there a generic version of INZIRQO 10 MG/ML ORAL SUSP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for INZIRQO 10 MG/ML ORAL SUSP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2044 — 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.

What it looks like

Color White
FlavorPeppermint
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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII LSU3YX0KZO
    Molasses is a thick syrup byproduct from sugar refining. It's used in medicines as a sweetener, flavor enhancer, and humectant to retain moisture and improve taste.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

12 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

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationNDA219141 (NDA)
Labeler code70954
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio299 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS & USAGE INZIRQO™ (hydrochlorothiazide) is a thiazide diuretic indicated for: The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction (1.1). The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including the nephrotic syndrome in adult and pediatric patients.

(1.2).

1.1Hypertension INZIRQO is indicated for the treatment of hypertension in adult and pediatric patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes., including the class to which this drug principally belongs.

Control of high blood pressure should be part of comprehensive cardiovascular risk management including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. INZIRQO can be used alone or in combination with other antihypertensive agents.

1.2Edema Treatment of edema associated with congestive heart failure, hepatic cirrhosis, and renal disease including the nephrotic syndrome in adult and pediatric patients.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE & ADMINISTRATION For the treatment of hypertension in adults: The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses(2.1). For the treatment of edema in adults: The recommended adult dosage is 25 mg to 100 mg orally daily as a single or divided dose.

Consider intermittent therapy to reduce the risk of electrolyte imbalances, i.e., administration on alternate days or on 3 to 5 days each week (2.2). For the treatment of hypertension and edema in pediatric patients: The recommended pediatric dosage is 1 mg/kg to 2 mg/kg orally per day in single or two divided doses. Do not exceed 37.5 mg per day in patients less than 2 years of age or 100 mg per day in children 2 to less than 13 years of age.

Patients less than 6 months of age may require doses up to 3 mg/kg orally per day in two divided doses (2.1, 2.2).

2.1Recommended Dosage for the Treatment of Hypertension The recommended initial dose in adults is 25 mg orally daily given as a single dose. As needed, increase the dose to 50 mg orally daily, given as a single or two divided doses. Pediatric Patients: The recommended dose in pediatric patients is 1 to 2 mg/kg per day in one or two divided doses not to exceed 37.5 mg in patients less than 2 years of age and 100 mg in patients 2 to less than 13 years of age.

In pediatric patients less than 6 months of age, doses up to 3 mg/kg per day in two divided doses may be required.

2.2Recommended Dosage for the Treatment of Edema The recommended adult dosage is 25 mg to 100 mg orally daily as a single or divided dose. Consider intermittent therapy to reduce the risk of electrolyte imbalances, i.e., administration on alternate days or on 3 to 5 days each week. Pediatric Patients: The recommended dose in pediatric patients is 1 to 2 mg/kg per day in one or two divided doses not to exceed 37.5 mg in patients less than 2 years of age and 100 mg in patients 2 to less than 13 years of age.

In pediatric patients less than 6 months of age, doses up to 3 mg/kg per day in two divided doses may be required.

2.3Preparation of Oral Suspension INZIRQO is supplied as a powder for oral suspension and must be reconstituted prior to dispensing. Gently shake the bottle to loosen the powder, add 66 mL of water and shake vigorously for minimum of 30 seconds. When reconstituted as directed, the solution will result in a 10 mg/mL concentration of hydrochlorothiazide.

Store the reconstituted solution at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Write the date of expiration of the reconstituted oral suspension (calculated as 30 days after reconstitution) on the bottle label.

2.4Important Administration Instructions Instruct patients or caregivers to use an oral dosing syringe to correctly measure the prescribed amount of medication. Inform patients that a bottle adapter and oral dosing syringes may be obtained from their pharmacy. Advise patients to always shake the bottle well prior to each use. INZIRQO may be administered with or without food [see Clinical Pharmacology (12.3)] .

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS & STRENGTHS For Oral Suspension: When reconstituted as directed, INZIRQO is an off-white to light brown colored suspension with caramel, peppermint flavor containing 10 mg/mL of hydrochlorothiazide, USP. For oral suspension: 10 mg/mL (3)

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS INZIRQO is contraindicated: In patients with anuria. In patients with hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO. In patients with hypersensitivity to sulfonamide-derived drugs. Anuria (4) Hypersensitivity to hydrochlorothiazide or any ingredient in INZIRQO (4) Hypersensitivity to sulfonamide-derived drugs (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Monitor kidney function periodically (5.1) Monitor and correct serum electrolytes prior to use and monitor periodically (5.2). Monitor blood sugar, lipid levels, uric acid and calcium levels periodically. (5.3) Exacerbation or activation of systemic lupus erythematosus (5.4) Acute angle-closure glaucoma and acute myopia (5.5)

5.1Impaired Renal Function Monitor kidney function periodically. Diuretics can cause hypovolemia which may precipitate acute kidney injury. Patients with chronic kidney disease, heart failure, or volume depletion may be at particular risk of developing acute renal failure on INZIRQO. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in kidney function while on INZIRQO.

5.2Electrolyte Abnormalities INZIRQO can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, and hypochloremic alkalosis. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Hypokalemia is dose dependent.

Monitor and correct serum electrolytes prior to use and monitor periodically. Discontinue INZIRQO if hypokalemia is associated with clinical symptoms (e.g., ECG changes, muscular weakness).

5.3Metabolic Disturbances INZIRQO may increase blood sugar levels, affect diabetes control, and cause changes in the need for diabetes medication. INZIRQO may raise serum levels of cholesterol and triglycerides. Monitor blood sugar and lipid levels.

INZIRQO may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Increases in serum uric acid are dose related. INZIRQO decreases urinary calcium excretion and may cause elevations of serum calcium.

Monitor calcium levels in patients with hypercalcemia receiving INZIRQO. Discontinue thiazides before carrying out tests for parathyroid function.

5.4Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

5.5Acute Angle-Closure Glaucoma and Acute Myopia Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in acute angle closure glaucoma and elevated intraocular pressure with or without a noticeable acute myopic shift and/or choroidal effusions. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma may result in permanent vision loss.

Discontinue drug intake. Consider prompt medical or surgical treatments if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following adverse reactions with INZIRQO are described elsewhere: Impaired Renal Function [see Warnings and Precautions (5.1)] Electrolyte Abnormalities [see Warnings and Precautions (5.2)] Metabolic Disturbances [see Warnings and Precautions (5.3)] Systemic Lupus Erythematosus [see Warnings and Precautions (5.4)] Acute Angle-Closure Glaucoma and Acute Myopia [see Warnings and Precautions (5.5)] Adverse reactions include hypokalemia, hyponatremia, hypomagnesemia, hyperglycemia, hyperuricemia, hyperlipidemia and hypotension.

See Adverse Reactions (6) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).

Gastrointestinal: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.

Metabolic: Electrolyte imbalance, hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle spasm. Nervous System: Vertigo, paresthesia, dizziness, headache, restlessness.

Renal: Renal failure, renal dysfunction, interstitial nephritis. Skin and Appendages: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia.

Urogenital System: Impotence.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of hydrochlorothiazide. Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses.

The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

🔄 Drug Interactions 209 words ▾

7 DRUG INTERACTIONS NSAID: May lead to increased risk of renal impairment and loss of diuretic and antihypertensive effect (7.1). Cholestyramine and colestipol: Reduced absorption of thiazides (7.1) Lithium: Increased lithium concentrations and lithium toxicity (7.2) Antidiabetic drugs: Dosage adjustment of antidiabetic may be required (7.2)

7.1Potential for Other Drugs to Affect INZIRQO Non-Steroidal Anti-Inflammatory Agents: Administration of a nonsteroidal anti-inflammatory agent, including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, when INZIRQO and nonsteroidal anti-inflammatory agents are used concomitantly, check to determine if the desired effect of the diuretic is obtained. Cholestyramine and Colestipol : Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Stagger the dosage of INZIRQO and the resin such that INZIRQO is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

7.2Potential for INZIRQO to Affect Other Drugs Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of hydrochlorothiazide. Monitor serum lithium levels during concomitant use and adjust the lithium dose during concomitant administration or discontinuation of hydrochlorothiazide. Antidiabetic Drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required when coadministered with hydrochlorothiazide.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes with hydrochlorothiazide use during pregnancy. However, there have been rare reports of jaundice, thrombocytopenia, and electrolyte imbalances in infants exposed to thiazide medications during pregnancy.

The 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 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Monitor pregnant women with hypertension. Data Animal Data Teratogenic effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide /kg (approximately 146-fold and 97-fold the maximum recommended human dose based on body surface area), respectively, provided no evidence of harm to the fetus.

8.2Lactation Risk Summary Available data from published literature indicate hydrochlorothiazide is present in human milk (see Data) . There are no reports of adverse effects on breastfed infants exposed to hydrochlorothiazide during lactation. Doses of hydrochlorothiazide associated with clinically significant diuresis have been associated with impaired milk production.

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for INZIRQO and any potential adverse effects on the breastfed infant from INZIRQO or from the underlying maternal condition. Data A single study involving one woman and her infant showed a peak concentration of 275 mcg/L at 3 hours following 50 mg dose. No drug was detected (<20 mcg/L) in the infant’s plasma at 2 and 11 hours following the mother’s dose.

8.4Pediatric Use INZIRQO is approved for use in pediatric patients for the following: Treatment of hypertension to lower blood pressure Treatment of edema associated with congestive heart failure, hepatic cirrhosis, and renal disease, including the nephrotic syndrome

8.5Hepatic Impairment Monitor for mental status changes when using INZIRQO in patients with hepatic impairment because fluid shifts may precipitate hepatic coma.

🤰 Pregnancy 216 words ▾

8.1Pregnancy Risk Summary Untreated hypertension during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations). Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes with hydrochlorothiazide use during pregnancy. However, there have been rare reports of jaundice, thrombocytopenia, and electrolyte imbalances in infants exposed to thiazide medications during pregnancy.

The 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 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Monitor pregnant women with hypertension. Data Animal Data Teratogenic effects: Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide /kg (approximately 146-fold and 97-fold the maximum recommended human dose based on body surface area), respectively, provided no evidence of harm to the fetus.

🧒 Pediatric Use 38 words ▾

8.4Pediatric Use INZIRQO is approved for use in pediatric patients for the following: Treatment of hypertension to lower blood pressure Treatment of edema associated with congestive heart failure, hepatic cirrhosis, and renal disease, including the nephrotic syndrome

🆘 Overdosage 37 words ▾

10 OVERDOSAGE The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The mechanism of the antihypertensive effect of thiazides is not fully understood.

12.2Pharmacodynamics Hydrochlorothiazide does not usually affect normal blood pressure. Hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage, all thiazides are approximately equal in their diuretic efficacy.

Hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate. After oral use, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours.

12.3Pharmacokinetics Over a dose range of 50 to 100 mg, peak plasma hydrochlorothiazide concentrations and exposure (AUC) of INZIRQO increases proportionally with dose in healthy subjects. Absorption Following single-dose oral administration of 100 mg INZIRQO to healthy subjects in the fasted state, the AUC and C max of hydrochlorothiazide was 5940 ng.h/mL and 972 ng/mL, respectively. The peak plasma hydrochlorothiazide concentrations are achieved at approximately 1.5 hours.

Effect of Food: A food-effect study involving administration of INZIRQO to healthy male and female subjects after a high-fat, high calorie breakfast indicated that the rate of absorption (C max ) decreased 38%, while the extent of absorption (AUC) remained unchanged, when compared to administration under fasting conditions. The T max was delayed by 2 hours. Cholestyramine and Colestipol Resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Single doses of either cholestyramine or colestipol resins reduced the bioavailability of hydrochlorothiazide by up to 85% and 43%, respectively. Distribution Hydrochlorothiazide binds to albumin (40% to 70%) and distributes into erythrocytes. It crosses the placental but not the blood-brain barrier and is excreted in breast milk.

Elimination Following oral administration of INZIRQO, plasma hydrochlorothiazide concentrations decline biexponentially, with a terminal elimination half-life of about 10 hours. At least 61% of the oral dose is eliminated unchanged in the urine within 24 hours.

🧬 Mechanism of Action 66 words ▾

12.1Mechanism of Action Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The mechanism of the antihypertensive effect of thiazides is not fully understood.

📦 How Supplied / Storage and Handling 139 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied INZIRQO (hydrochlorothiazide) is supplied as an off-white to light-brown colored powder for oral suspension in one strength containing 800 mg of hydrochlorothiazide, USP in a HDPE bottle. When reconstituted as directed, INZIRQO forms an off-white to light brown colored suspension with caramel, peppermint flavor. The total volume of the suspension is 80 mL containing 10 mg of hydrochlorothiazide, USP per mL (70954-522-10).

16.2Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep this and all medication out of the reach of children. Store reconstituted solutions of INZIRQO at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. [see Dosage and Administration (2.3)].

📋 Description 169 words ▾

11 DESCRIPTION Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids.

The molecular formula is C 7 H 8 ClN 3 O 4 S 2 and the molecular weight is 297.74. INZIRQO (hydrochlorothiazide) is supplied in one strength as an off-white to light-brown colored powder for oral suspension. When reconstituted with 66 mL of water, the total volume of the suspension is 80 mL containing 10 mg/mL of hydrochlorothiazide, USP.

In addition, INZIRQO contains the following inactive ingredients: anhydrous citric acid, caramel flavor (artificial flavor, caramel, maltodextrin, molasses, propylene glycol, salt and sucrose), cellulose, peppermint flavor (acacia and natural flavor), potassium sorbate, sucrose, talc and xanthan gum. structure

💬 Information for Patients 190 words ▾

17 PATIENT COUNSELING INFORMATION Acute Angle-Closure Glaucoma and Acute Myopia Advise patients to discontinue INZIRQO and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.5)] . Non-melanoma Skin Cancer Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening [see Postmarketing Experience (6.2)]. Recommended Administration Advise patients to always shake the bottle well before each use and measure the dose using a calibrated oral dosing syringe to ensure that the dose is measured and administered accurately.

Inform patients that a bottle adapter and oral dosing syringes may be obtained from their pharmacy. Advise patients never to use household teaspoons or tablespoons to measure INZIRQO. Advise patients that the oral suspension should be stored at room temperature (20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)).

INZIRQO may be taken with or without meals. Discard any unused suspension 30 days after reconstitution. Trademarks are the property of their respective owners.

Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623 LB4824-01 INZIRQO is a pending trademark of ANI Pharmaceuticals, Inc.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Over a dose range of 50 to 100 mg, peak plasma hydrochlorothiazide concentrations and exposure (AUC) of INZIRQO increases proportionally with dose in healthy subjects. Absorption Following single-dose oral administration of 100 mg INZIRQO to healthy subjects in the fasted state, the AUC and C max of hydrochlorothiazide was 5940 ng.h/mL and 972 ng/mL, respectively. The peak plasma hydrochlorothiazide concentrations are achieved at approximately 1.5 hours.

Effect of Food: A food-effect study involving administration of INZIRQO to healthy male and female subjects after a high-fat, high calorie breakfast indicated that the rate of absorption (C max ) decreased 38%, while the extent of absorption (AUC) remained unchanged, when compared to administration under fasting conditions. The T max was delayed by 2 hours. Cholestyramine and Colestipol Resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.

Single doses of either cholestyramine or colestipol resins reduced the bioavailability of hydrochlorothiazide by up to 85% and 43%, respectively. Distribution Hydrochlorothiazide binds to albumin (40% to 70%) and distributes into erythrocytes. It crosses the placental but not the blood-brain barrier and is excreted in breast milk.

Elimination Following oral administration of INZIRQO, plasma hydrochlorothiazide concentrations decline biexponentially, with a terminal elimination half-life of about 10 hours. At least 61% of the oral dose is eliminated unchanged in the urine within 24 hours.

🧬 Pharmacodynamics 75 words ▾

12.2Pharmacodynamics Hydrochlorothiazide does not usually affect normal blood pressure. Hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage, all thiazides are approximately equal in their diuretic efficacy.

Hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate. After oral use, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours.

🧪 Nonclinical Toxicology 176 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Two year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity)and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans nondisjunction assay at an unspecified concentration.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 173 words ▾

13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Two year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.

Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity)and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 mcg/mL, and in the Aspergillus nidulans nondisjunction assay at an unspecified concentration.

📄 Package Label / Principal Display Panel 20 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL INZIRQO (hydrochlorothiazide) Powder for Oral Suspension, 10 mg/mL NDC 70954-522-10 - 80 mL (when reconstituted) inzirqo

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

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 this package alone, 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.
📅 Q2 2025 – Q4 2025 · 3 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
341
Units reimbursed last 4 qtrs
31.1K
Gross reimbursed last 4 qtrs
$143.5K
Avg / prescription
$420.86
Avg / unit
$4.6210
Latest quarter Q4 2025
250Rx
Medicaid pays / mL
$4.6210
gross reimbursed
vs
NADAC / mL
$4.4617
acquisition cost
=
Spread
+$0.1593
+4% 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 ⓘ
50% FFS 50% MCO
Fee-for-service · 170 Rx Managed care · 171 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 4,560 units · 58.4 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: 2,210 units · 37.4 per 100k residents WI Michigan: no data reported MI New York: 7,165 units · 36.6 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: 1,280 units · 10.2 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 2,400 units · 18.5 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 882 units · 12.6 per 100k residents MA California: 2,800 units · 7.2 per 100k residents CA Utah: 2,560 units · 74.9 per 100k residents UT Colorado: 800 units · 13.6 per 100k residents 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: 960 units · 15.5 per 100k residents MD Connecticut: 1,280 units · 35.4 per 100k residents 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: 880 units · 8.1 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: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,440 units · 4.7 per 100k residents TX Florida: 1,840 units · 8.1 per 100k residents FL
Units reimbursed · per 100k residents
4.774.9
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 Utah 74.9 /100k
2 Washington 58.4 /100k
3 Wisconsin 37.4 /100k
4 New York 36.6 /100k
5 Connecticut 35.4 /100k
6 Pennsylvania 18.5 /100k
7 Maryland 15.5 /100k
8 Colorado 13.6 /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 Inzirqo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Inzirqo. 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
$10.6K
Claims incl. refills
27
Beneficiaries
20
Spend / beneficiary
$532.12
Spend / claim
$394.16
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 INZIRQO (this brand).

Top reported reactions

Fatigue10,333
Nausea9,969
Diarrhoea8,593
Pain7,862
Headache7,778
Dyspnoea7,767
Dizziness7,497

Reporter sex

144,410 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Death10,120
Disabling3,676
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,142 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.
← 70954-0518-10 · Novitium 70954-0530-20 · ANI →
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.