FDA-filed SPL labeling · retrieved through openFDA

Valsartan and Hydrochlorothiazide

Valsartan and hydrochlorothiazide is a combination blood pressure medication used to treat high blood pressure (hypertension) in adults.

Brand name Diovan HCT
Drug classes Angiotensin 2 Receptor Blocker
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 56 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 13, 2026
Clinical labels in scope 56
AvailabilityRx
Earliest approval/marketing year 1998
FDA-listed product records 221
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Valsartan and Hydrochlorothiazide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Valsartan and hydrochlorothiazide is an effective combination tablet for treating high blood pressure, pairing a blood vessel-relaxing ARB with a water pill to lower blood pressure from two angles at once. It is not safe during pregnancy and must be stopped immediately if you become pregnant. Keep all follow-up appointments so your doctor can check your kidney function, electrolytes, and blood pressure response.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Warning: This medication can cause serious harm or death to an unborn baby. Valsartan works on the renin-angiotensin system — a hormone pathway that a developing fetus depends on for normal kidney development. If you take this medication during the second or third trimester of pregnancy, it can reduce the baby's kidney function, cause low amniotic fluid, and lead to birth defects, organ damage, or even death of the baby. If you find out you are pregnant at any point while taking this medication, stop it immediately and contact your doctor. Do not wait for your next appointment.

Read the full warning on DailyMed →

📖 Valsartan and Hydrochlorothiazide: Patient Information Guide

A plain-language walkthrough of Valsartan and Hydrochlorothiazide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Valsartan and hydrochlorothiazide is a combination oral tablet approved to treat high blood pressure (hypertension) in adults. It is used in three main situations:

  • As add-on therapy when a single blood pressure medication (valsartan alone or HCTZ alone) isn't controlling blood pressure well enough
  • As replacement therapy for patients already taking both valsartan and hydrochlorothiazide as separate pills who are tolerating them well
  • As initial combination therapy for patients whose blood pressure is high enough that one drug is unlikely to be sufficient — both Diovan HCT and generic valsartan and hydrochlorothiazide tablets are approved for this use, though this approach is not recommended if you are dehydrated or low on body fluids

Lowering blood pressure with this medication reduces the risk of stroke and heart attack. It is not a cure for hypertension and works best as part of a broader plan that may include diet, exercise, limiting sodium, and managing other risk factors.

⚙️How it works

Valsartan and hydrochlorothiazide tackles high blood pressure from two directions at once. Valsartan is an angiotensin II receptor blocker (ARB): it blocks a hormone called angiotensin II from binding to receptors in blood vessel walls and the adrenal glands. Normally, angiotensin II causes blood vessels to tighten and tells the body to hold on to sodium — both of which raise blood pressure. By blocking those signals, valsartan helps blood vessels relax and blood pressure fall. Hydrochlorothiazide (HCTZ) is a thiazide diuretic that acts on the kidneys, prompting them to excrete more sodium and water. Less fluid in circulation means less pressure on vessel walls. Because valsartan counteracts some of the potassium loss that HCTZ tends to cause, the two ingredients complement each other well.

💊How it's taken

Valsartan and hydrochlorothiazide tablets are taken by mouth once a day and can be taken with or without food. Your prescriber will start you at an appropriate dose and may adjust it after 1 to 2 weeks depending on how your blood pressure responds; full effects after a dose change are usually seen within 2 to 4 weeks. Always follow your prescriber's specific instructions — do not adjust your dose on your own.

  • Can be taken with or without a meal
  • Dosed once daily
  • May be used alongside other blood pressure medications if your doctor recommends it
  • If you miss a dose, follow your pharmacist's or prescriber's guidance — do not double up
🤒Side effects — in detail

Most people tolerate valsartan and hydrochlorothiazide well, but some side effects can occur:

  • Dizziness or lightheadedness (especially when standing up quickly)
  • Headache
  • Nasopharyngitis — stuffy or runny nose and sore throat
  • Nausea, upset stomach, or diarrhea
  • Fatigue or weakness
  • Back pain or muscle aches
  • Cough
  • Rapid or irregular heartbeat (palpitations)

More serious reactions — like a sharp drop in blood pressure, significant changes in kidney function, dangerously high or low potassium, sudden eye pain with vision changes, or signs of a severe allergic reaction — require prompt medical attention. Contact your doctor or seek emergency care right away if any of these occur.

⚠️Warnings & precautions
  • Pregnancy: This medication can cause serious injury or death to a developing baby. Stop it immediately and call your doctor if you become pregnant.
  • Low blood pressure (hypotension): Most likely to occur if you are dehydrated, on a low-salt diet, or taking high-dose diuretics. Lie down and seek help if you feel faint.
  • Kidney function: This medication can affect the kidneys, especially in people who already have kidney disease, renal artery narrowing, severe heart failure, or low fluid volume. Your doctor should check kidney function periodically.
  • Potassium imbalance: HCTZ can lower potassium (hypokalemia); valsartan can raise it (hyperkalemia). Both extremes can affect heart rhythm. Your electrolytes will need monitoring.
  • Acute angle-closure glaucoma: HCTZ can rarely cause a sudden eye pressure spike with eye pain and blurred vision — a medical emergency. Seek care immediately if this happens.
  • Metabolic effects: HCTZ can raise blood sugar, uric acid (worsening gout), cholesterol, and calcium levels, and can activate or worsen lupus in susceptible people.
  • Lithium toxicity: This combination can significantly raise lithium blood levels. If you take lithium, your levels must be monitored closely.
🔀What it interacts with

Several medications, supplements, and substances can interact with valsartan and hydrochlorothiazide:

  • Lithium — blood levels can rise to toxic amounts; close monitoring required
  • NSAIDs and COX-2 inhibitors (ibuprofen, naproxen, celecoxib) — can blunt blood pressure control and raise the risk of kidney damage, especially in older adults or those on diuretics
  • Potassium-raising agents (potassium supplements, potassium-sparing diuretics like spironolactone, salt substitutes, heparin) — can push potassium to dangerous levels when combined with valsartan
  • Aliskiren — must not be combined in patients with diabetes; avoid in patients with significant kidney impairment
  • Other ACE inhibitors or ARBs — dual blockade of the renin-angiotensin system increases risk of low blood pressure, high potassium, and acute kidney failure
  • Diabetes medications (insulin, oral agents) — HCTZ can raise blood sugar, so dose adjustments may be needed
  • Cholestyramine or colestipol — can greatly reduce HCTZ absorption; take HCTZ at least 4 hours before or 4–6 hours after these resins
  • Alcohol, sedatives, narcotics, or barbiturates — can worsen dizziness upon standing (orthostatic hypotension)
  • Digoxin — low potassium or magnesium caused by HCTZ can increase the risk of digoxin toxicity
  • Cyclosporine — may increase risk of high uric acid and gout when combined with HCTZ; may also increase valsartan exposure

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Pregnancy: Do not use this medication if you are pregnant or planning to become pregnant — it can seriously harm the baby
  • Breastfeeding: Breastfeeding is not recommended while taking this medication
  • Children: Safety and effectiveness have not been established in pediatric patients
  • Older adults: May be more sensitive to blood pressure drops and electrolyte changes; no dose adjustment is required but closer monitoring may be appropriate
  • Kidney impairment: Use in severe kidney impairment (creatinine clearance at or below 30 mL/min) has not been established; mild-to-moderate impairment generally does not require dose adjustment
  • Liver impairment: Valsartan dose adjustment is not needed for mild-to-moderate liver disease; no dosing recommendation exists for severe liver disease. HCTZ can trigger hepatic coma in those with serious liver disease
  • Allergy to sulfonamide drugs or penicillin: You may have a higher risk of the rare acute angle-closure glaucoma reaction from HCTZ
  • Diabetes: HCTZ can affect blood sugar control; also, aliskiren must not be combined with this medication if you have diabetes
  • Gout or high uric acid: HCTZ can raise uric acid and trigger gout flares
  • Lupus: HCTZ may activate or worsen systemic lupus erythematosus
  • Dehydration or low sodium/fluid status: Correct before starting, as blood pressure may drop too low
🚑If you take too much

Taking too much valsartan and hydrochlorothiazide is most likely to cause a significant drop in blood pressure (hypotension) and a fast heart rate (tachycardia); a very slow heart rate (bradycardia) is also possible. Electrolyte problems — particularly low potassium, low sodium, and low chloride — and dehydration from excessive fluid loss are the other main concerns with HCTZ overdose. If overdose is suspected, seek emergency medical care immediately; supportive treatment is the main approach, as valsartan is not removed by dialysis.

📡Pharmacodynamics — effects in the body

Valsartan measurably blocks the blood pressure-raising effects of angiotensin II. After the HCTZ component is absorbed, its diuretic (urine-producing) effect begins within about 2 hours, peaks around 4 hours, and lasts roughly 6 to 12 hours. HCTZ can lower potassium and magnesium levels in the blood, while valsartan has very little effect on potassium by itself — and tends to counteract the potassium loss caused by HCTZ when the two are combined. Alcohol, sedatives, and narcotic pain medications can amplify the blood pressure-lowering effect of this combination, increasing the risk of dizziness upon standing.

🔬Pharmacokinetics — how your body processes it

Valsartan reaches peak blood levels about 2 to 4 hours after a dose and has an elimination half-life of roughly 6 hours; it is mostly cleared through the stool. Food does not meaningfully affect HCTZ absorption, but it can reduce how much valsartan the body absorbs — so taking the tablet consistently (with or without food each day) is more important than timing it around meals. HCTZ is absorbed within 2 to 5 hours, has an elimination half-life of about 10 hours, and is excreted largely unchanged in the urine. In older adults, valsartan exposure is notably higher and its half-life longer than in younger people, and HCTZ clearance is also reduced — so older patients may need careful monitoring.

📦How to store it

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). Protect from moisture. Dispense in tight container (USP).

📄 Written from Valsartan and Hydrochlorothiazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Valsartan and Hydrochlorothiazide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medication and why did my doctor prescribe it?
This tablet combines two different blood pressure-lowering medicines in one pill: valsartan, which relaxes your blood vessels, and hydrochlorothiazide, a water pill that helps your kidneys flush out extra fluid. Together they lower high blood pressure more effectively than either one alone. Your doctor likely prescribed it because one blood pressure medication wasn't enough, or because your blood pressure was high enough from the start that a combination made sense.
Does it matter if I take it with food or on an empty stomach?
You can take it either way — with or without food. The hydrochlorothiazide part isn't affected by food at all. Food does reduce how much valsartan your body absorbs, but since you take the same approach every day, your body adjusts and your doctor sets your dose accordingly. The most important thing is to take it at roughly the same time each day so your blood pressure stays consistently controlled.
What side effects should I watch out for?
The most common things people notice are dizziness (especially when standing up quickly), headache, and a stuffy or runny nose. Muscle aches, fatigue, and mild stomach upset can also happen. These are usually mild and settle down. However, call your doctor right away if you have a sharp drop in blood pressure that makes you feel faint, notice significantly less urine output, develop sudden eye pain or blurred vision, or feel your heart racing or beating irregularly — those are signs that need prompt attention.
I just found out I'm pregnant. What should I do?
Stop taking this medication right away and call your doctor today — do not wait. This is one of the most important warnings for this drug. Valsartan works on a hormone system that a developing baby needs for normal kidney development, and taking it during pregnancy — especially the second and third trimesters — can cause serious harm or even death to the baby. Your doctor will switch you to a safer blood pressure option right away.
Are there any common medications or supplements I should avoid?
Yes — a few important ones. Anti-inflammatory painkillers like ibuprofen or naproxen can weaken this medication's effect and raise the risk of kidney problems, so try to avoid them or use them only briefly if truly needed. Potassium supplements or salt substitutes that contain potassium can push your potassium levels dangerously high when combined with valsartan. If you take lithium, your levels need to be monitored closely because this combination can raise them to toxic amounts. Always tell any prescriber or pharmacist about everything you take, including vitamins and herbal supplements.
How long will it take to see if this medication is working?
You may start to see some blood pressure lowering within the first week or two, but the full effect after any dose change takes about 2 to 4 weeks. That's why your doctor may want to check your blood pressure a few weeks after you start or after any dose adjustment before deciding whether a change is needed. Keep taking it every day even if you feel fine — high blood pressure usually has no symptoms, and the goal is long-term protection against stroke and heart attack.
Is Valsartan and Hydrochlorothiazide available over the counter?
Valsartan and Hydrochlorothiazide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Valsartan and Hydrochlorothiazide first available?
Valsartan and Hydrochlorothiazide has been available in the United States since at least 1998, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Valsartan and Hydrochlorothiazide?
Valsartan and Hydrochlorothiazide is supplied by 24 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, Mylan Pharmaceuticals Inc..

💬 Answers drafted from Valsartan and Hydrochlorothiazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Valsartan and Hydrochlorothiazide comes

Valsartan and Hydrochlorothiazide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Diovan HCT
How this form is used
What it may be used for
  • Diovan HCT tablets are used to treat high blood pressure (hypertension) in adults whose blood pressure is not controlled on a single medication
  • Diovan HCT tablets may be used as initial therapy for high blood pressure in patients likely to need more than one drug to reach their blood pressure goal
  • Valsartan and Hydrochlorothiazide tablets are indicated to treat high blood pressure, including as add-on therapy when monotherapy is not enough
  • Valsartan and Hydrochlorothiazide tablets may be substituted for two separately taken blood pressure medications (valsartan and HCTZ) that are already working well
Important instructions
  • Take tablets by mouth once daily, with or without food
  • Diovan HCT: the usual starting dose is once daily; your doctor may adjust your dose after 1 to 2 weeks if needed, up to a maximum of one tablet daily
  • Full blood pressure-lowering effect after a dose change may take 2 to 4 weeks
  • Diovan HCT is not recommended as initial therapy if you are dehydrated or severely volume-depleted
Available strengths 10 strengths
Show 4 more strengths Show fewer strengths
221 FDA-listed product records

📊 Valsartan and Hydrochlorothiazide across the U.S. market

How Valsartan and Hydrochlorothiazide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
24
Manufacturers
2
Brand names
221
FDA-listed product records
1998
First marketed
A-S Medication Solutions14%
Bryant Ranch Prepack7%
Mylan Pharmaceuticals Inc.7%
Solco Healthcare US, LLC7%
Novartis Pharmaceuticals Corporation7%
Aurobindo Pharma Limited7%
Other makers52%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Valsartan and Hydrochlorothiazide is used

A general measure of how commonly Valsartan and Hydrochlorothiazide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Valsartan and Hydrochlorothiazide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

208,319
Medicaid prescriptions filled (Q1–Q4 2025)
$3.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Valsartan and Hydrochlorothiazide prescribed? Of the 1,596 medications we measure, Valsartan and Hydrochlorothiazide ranks #387 by Medicaid prescriptions — more than 76% of them.

Where Valsartan and Hydrochlorothiazide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Valsartan and Hydrochlorothiazide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 25 mg / 320 mg oral tablet is the most-dispensed Valsartan and Hydrochlorothiazide product — about 27% of these Medicaid prescriptions.

hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet Most dispensed

56,125 Medicaid prescriptions (Q1–Q4 2025) 27% of Valsartan and Hydrochlorothiazide prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 9 of 59 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636045

hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet

54,384 Medicaid prescriptions (Q1–Q4 2025) 26% of Valsartan and Hydrochlorothiazide prescriptions shown $872,117 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 8 of 79 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200285

hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet

41,028 Medicaid prescriptions (Q1–Q4 2025) 20% of Valsartan and Hydrochlorothiazide prescriptions shown $664,038 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 6 of 54 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349353

hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet

33,070 Medicaid prescriptions (Q1–Q4 2025) 16% of Valsartan and Hydrochlorothiazide prescriptions shown $530,577 gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 5 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200284

hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet

23,712 Medicaid prescriptions (Q1–Q4 2025) 11% of Valsartan and Hydrochlorothiazide prescriptions shown $509,526 gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 8 of 54 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 636042

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Valsartan and Hydrochlorothiazide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 36 of 311 listed Valsartan and Hydrochlorothiazide NDCs with Medicaid activity.

🔍 Compare Valsartan and Hydrochlorothiazide products

A representative set of FDA-listed product records for Valsartan and Hydrochlorothiazide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 221 products — FDA National Drug Code Directory. See every product, package size and price: browse all 221 Valsartan and Hydrochlorothiazide NDCs →

🏷️ Sold under these brand names

Diovan HCT

🏭 Manufacturers & labelers

A-S Medication Solutions 31 Bryant Ranch Prepack 16 Mylan Pharmaceuticals Inc. 15 Solco Healthcare US, LLC 15 Novartis Pharmaceuticals Corporation 15 Aurobindo Pharma Limited 15 RPK Pharmaceuticals, Inc. 12 Proficient Rx LP 12 Lupin Pharmaceuticals, Inc. 10 Amneal Pharmaceuticals LLC 10 AvKARE 10 Alembic Pharmaceuticals Inc. 10 Alembic Pharmaceuticals Limited 10 Northwind Health Company, LLC 6 Zydus Lifesciences Limited 5 Amneal Pharmaceuticals of New York LLC 5 Macleods Pharmaceuticals Limited 5 ScieGen Pharmaceuticals, INC. 5 NuCare Pharmaceuticals,Inc. 4 Preferred Pharmaceuticals Inc. 3 Denton Pharma, Inc. DBA Northwind Pharmaceuticals 2 Northwind Pharmaceuticals, LLC 2 Northwind Pharmaceuticals 2 Aphena Pharma Solutions - Tennessee, LLC 1

RxNorm drug class

Valsartan and Hydrochlorothiazide belongs to the Thiazide Diuretic class.

Pharmacologic class Thiazide Diuretic
Drug family (ATC) Renin-inhibitors, Thiazides, plain

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 13, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Valsartan and Hydrochlorothiazide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Valsartan and Hydrochlorothiazide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
56
NDC products indexed
221
Distinct labelers/manufacturers represented
24
Linked representative label
Novartis Pharmaceuticals Corporation
Linked label effective
Feb 13, 2026
Composite sections available
23
Linked SPL Set ID
d76a0419-05ee-437e-884c-65807aea9569
Linked SPL Document ID
c42c209a-1ad4-43a9-a4f6-33a435fb44e7
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 56 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.