FDA-filed SPL labeling · retrieved through openFDA

Dapagliflozin / Metformin

Dapagliflozin/metformin is a two-ingredient combination used to improve blood sugar control in type 2 diabetes and, through the dapagliflozin component, to reduce serious risks in heart failure and chronic kidney disease.

Brand names Xigduo XrXigduo
Drug classes ⓘ Biguanides
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 9 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 effectiveDec 20, 2024
Clinical labels in scope ⓘ9
AvailabilityRx
Earliest approval/marketing year ⓘ2014
FDA-listed product records ⓘ60
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Dapagliflozin / Metformin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dapagliflozin/metformin extended-release tablets combine two blood sugar-lowering medicines for type 2 diabetes, and the dapagliflozin component also offers important protection against serious complications of heart failure and chronic kidney disease. The metformin component carries a serious risk of lactic acidosis, especially in people with kidney or liver problems, so regular monitoring is essential. Take it once daily in the morning with food, never crush the tablet, and contact your doctor immediately if you develop muscle pain, trouble breathing, stomach pain, or unusual tiredness.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This medication carries a serious boxed warning about lactic acidosis — a dangerous and sometimes fatal buildup of lactic acid in the blood caused by metformin. It often starts with vague symptoms like muscle aches, fatigue, stomach pain, difficulty breathing, or unusual sleepiness. Severe cases can cause dangerously low blood pressure, abnormal heart rhythms, and low body temperature. People most at risk include those with kidney problems, liver disease, heart failure, those aged 65 or older, heavy alcohol users, and people undergoing surgery or imaging tests with contrast dye. If lactic acidosis is suspected, this medication must be stopped immediately and the person treated in a hospital — dialysis is often needed to remove metformin from the body.

Read the full warning on DailyMed →

📖 Dapagliflozin / Metformin: Patient Information Guide

A plain-language walkthrough of Dapagliflozin / Metformin — 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▾

Dapagliflozin/metformin extended-release tablets are approved for several uses depending on the specific product:

  • Improve blood sugar control in adults with type 2 diabetes (all products), used alongside diet and exercise
  • Xigduo XR is also approved to improve blood sugar control in children aged 10 and older with type 2 diabetes
  • Reduce the risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of worsening (dapagliflozin component, in adults with type 2 diabetes)
  • Reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure (dapagliflozin component)
  • Reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors (dapagliflozin component)
  • Not approved for type 1 diabetes, polycystic kidney disease, or for people recently on immunosuppressive therapy for kidney disease
⚙️How it works▾

Dapagliflozin blocks a protein in the kidneys called SGLT2 (sodium-glucose cotransporter 2), which is normally responsible for pulling filtered glucose back into the bloodstream. Blocking it causes excess glucose and sodium to be excreted in urine, lowering blood sugar. This sodium loss also reduces fluid buildup and pressure on the heart and kidneys, which is why dapagliflozin benefits people with heart failure and kidney disease. Metformin lowers blood sugar by reducing the liver's glucose output, slowing glucose absorption from the intestines, and making the body's own insulin work more effectively — without directly stimulating insulin release.

💊How it's taken▾

These extended-release tablets are taken once daily in the morning with food. The tablet must be swallowed whole — do not crush, cut, or chew it. Your doctor will personalize your starting dose based on your current medications. If you were previously taking an evening dose of metformin extended-release, skip that last dose before switching to this combination tablet. Follow your prescriber's instructions closely; dose adjustments may be made based on how well your blood sugar is controlled and how well you tolerate the medication.

  • Take in the morning with food every day
  • Swallow whole — never break or chew the tablet
  • Kidney function will be checked before you start and periodically during treatment
  • This medication may need to be paused before surgery, imaging with contrast dye, or periods of restricted eating or drinking
🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

  • Female genital yeast infections
  • Male genital yeast infections
  • Urinary tract infections
  • Diarrhea
  • Nausea or vomiting
  • Headache
  • Increased urination
  • Nasopharyngitis (runny nose, sore throat)

Serious reactions to watch for include signs of lactic acidosis (muscle pain, difficulty breathing, stomach pain, unusual tiredness), ketoacidosis, severe urinary or kidney infections, low blood pressure from dehydration, and rare but serious genital skin infections. Seek medical attention immediately if any of these occur.

⚠️Warnings & precautions▾
  • Lactic acidosis (metformin): A rare but potentially fatal buildup of lactic acid in the blood. Risk is higher with kidney problems, liver disease, heart failure, age 65+, heavy alcohol use, surgery, or contrast imaging. Symptoms include muscle pain, stomach pain, difficulty breathing, and unusual sleepiness. Stop the medication and go to a hospital immediately if suspected.
  • Ketoacidosis (dapagliflozin): Can occur even with blood sugar levels that are not dramatically elevated. Watch for nausea, vomiting, stomach pain, or shortness of breath. Stop this medication and seek care right away.
  • Volume depletion and low blood pressure: Dapagliflozin increases urination, which can lead to dehydration and low blood pressure, especially in older adults, those on diuretics, or those with kidney problems.
  • Serious urinary tract infections: Including kidney infections (pyelonephritis) and bloodstream infections (urosepsis) requiring hospitalization — report symptoms promptly.
  • Fournier's gangrene: A rare, life-threatening infection of the genital and groin area. Seek emergency care for pain, redness, swelling, or fever in that area.
  • Vitamin B12 deficiency: Metformin can lower B12 levels over time. Annual blood monitoring is recommended.
  • Low blood sugar: Risk increases if taken alongside insulin or sulfonylureas — your doctor may adjust those doses.
🔀What it interacts with▾

Several medications and substances can interact with this combination and either increase risks or change how well it works:

  • Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide): increase the risk of lactic acidosis when combined with metformin
  • Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine): can raise metformin levels and increase lactic acidosis risk
  • Insulin or sulfonylureas: increase the risk of low blood sugar; dose reductions of those drugs may be needed
  • Alcohol: heavy drinking worsens metformin's effect on lactic acid metabolism — avoid excessive intake
  • Blood-sugar-raising drugs (e.g., thiazide diuretics, corticosteroids, estrogens, oral contraceptives, phenytoin, nicotinic acid): can blunt the blood sugar-lowering effect of this medication
  • Lithium: SGLT2 inhibitors may lower lithium blood levels — monitor lithium more frequently
  • Iodinated contrast dye (used in imaging scans): can acutely harm kidneys and trigger lactic acidosis — this medication may need to be paused before and after such procedures

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▾
  • Do not take if you have severe kidney impairment (eGFR below 30 mL/min/1.73 m²) or are on dialysis
  • Do not take if you have had a serious allergic reaction (anaphylaxis or angioedema) to dapagliflozin or metformin
  • Do not take if you have metabolic acidosis or diabetic ketoacidosis — these require different treatment
  • Avoid this medication if you have liver disease — impaired liver function raises the risk of lactic acidosis
  • Older adults (65+) face a higher risk of lactic acidosis and low blood pressure — kidney function should be monitored more frequently
  • Not recommended during the second and third trimesters of pregnancy due to potential effects on fetal kidney development
  • Not recommended while breastfeeding — potential risk to the developing infant's kidneys
  • Premenopausal women who are not trying to conceive should discuss contraception, as metformin may restore ovulation
  • Not recommended for type 1 diabetes or for chronic kidney disease in patients with polycystic kidney disease or those on recent immunosuppressive therapy for kidney disease
  • Tell your doctor about any planned surgery or procedures — this medication may need to be temporarily stopped
🚑If you take too much▾

In case of overdose, call Poison Control at 1-800-222-1222 or seek emergency care. Metformin overdose can cause lactic acidosis in a significant number of cases, which is a medical emergency. Metformin can be removed from the body with hemodialysis (dialysis), which may help in severe overdose situations.

📡Pharmacodynamics — effects in the body▾

Dapagliflozin causes the kidneys to excrete glucose in the urine rather than reabsorbing it — this glucose-lowering effect begins shortly after dosing and results in meaningful amounts of glucose lost in urine each day. This urinary glucose loss also increases urine volume. The sodium loss that accompanies it may reduce the fluid and pressure load on the heart (both pre- and afterload) and lower pressure inside the kidney's filtering units. Metformin lowers blood sugar without causing the pancreas to produce more insulin, so fasting insulin levels may actually decrease during therapy.

🔬Pharmacokinetics — how your body processes it▾

When these combination extended-release tablets are taken with food, the overall amount of both dapagliflozin and metformin absorbed stays the same as in the fasted state — food can slightly delay dapagliflozin's peak level but this is not clinically meaningful. Dapagliflozin reaches peak blood levels within about 2 hours and has a half-life (the time for blood levels to drop by half) of about 13 hours; it is mainly broken down by the liver and cleared through the kidneys. Metformin in the extended-release formulation reaches peak levels in 4 to 8 hours, is not broken down by the liver at all, and is cleared almost entirely by the kidneys within 24 hours — which is why kidney function is so important for safe metformin use.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

📄 Written from Dapagliflozin / Metformin’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 Dapagliflozin / Metformin — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medication actually doing for me — is it just for blood sugar? ▾
It does more than just lower blood sugar. The metformin part helps your body handle glucose more efficiently, while the dapagliflozin part flushes excess sugar out through your urine. On top of that, dapagliflozin has been shown to protect the heart and kidneys — it can reduce the risk of hospitalization for heart failure and slow the progression of chronic kidney disease in people with type 2 diabetes. So depending on why your doctor prescribed it, you may be getting multiple benefits from one tablet.
I heard metformin can cause a dangerous condition called lactic acidosis. Should I be worried? ▾
Lactic acidosis is real and listed as a serious warning, but it's also quite rare when metformin is used carefully in the right patients. The risk is higher if you have kidney problems, liver disease, drink heavily, or are 65 or older — which is why your doctor checks your kidney function before and during treatment. Early warning signs include muscle aches, stomach pain, trouble breathing, or unusual tiredness. If you notice those, stop the medication and call your doctor or go to the ER right away. For most people without those risk factors, the benefit of metformin far outweighs this risk.
What side effects should I actually expect day to day? ▾
The most common ones are digestive — diarrhea and nausea are more likely with metformin, especially when you first start. Taking it with food and not skipping meals helps a lot. Dapagliflozin causes you to urinate more and can lead to genital yeast infections, which are more common in women but can happen in men too. Urinary tract infections are also more frequent. Most of these are manageable, but if you develop burning or pain with urination, a fever, or back pain, let your doctor know promptly.
Do I need to stop this medication before surgery or a scan with dye? ▾
Yes, and this is important. Before any surgery or procedure where you'll be fasting for a long time, your doctor will likely ask you to hold this medication for at least 3 days beforehand. Before imaging tests that use iodinated contrast dye — like certain CT scans — the medication may also need to be paused, because the dye can temporarily affect kidney function and raise the risk of lactic acidosis. Always tell your surgeon, anesthesiologist, or radiologist that you take this medication before any procedure.
Can I take this if I'm pregnant or trying to get pregnant? ▾
This medication is not recommended during the second and third trimesters of pregnancy because animal studies showed it can affect the developing kidneys of the baby. Breastfeeding is also not recommended. Interestingly, metformin can sometimes restore ovulation in women who aren't normally ovulating, so if you're premenopausal and not trying to become pregnant, talk to your doctor about contraception. If you are planning a pregnancy, let your care team know so they can help you find the safest plan for managing your diabetes.
How do I take this tablet correctly — does it matter when or with what? ▾
Take it once in the morning with food — that's the key routine. The food helps reduce stomach upset from the metformin component and is how the tablet is designed to be taken. Most importantly, swallow it whole. Never crush, cut, or chew it, because the extended-release coating controls how slowly the medication is released — breaking it disrupts that. If you're switching from taking metformin on its own in the evening, skip that last evening dose before you start this combination tablet.
Is Dapagliflozin / Metformin available over the counter? ▾
Dapagliflozin / Metformin 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 Dapagliflozin / Metformin first available? ▾
Dapagliflozin / Metformin has been available in the United States since at least 2014, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dapagliflozin / Metformin? ▾
Dapagliflozin / Metformin is supplied by 10 manufacturers listed in the FDA NDC Directory, including AstraZeneca Pharmaceuticals LP, Novadoz Pharmaceuticals LLC, Macleods Pharmaceuticals Limited.

💬 Answers drafted from Dapagliflozin / Metformin’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

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💊 How Dapagliflozin / Metformin comes

Dapagliflozin / Metformin 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.

Extended-release tablet

By mouth
Brands Xigduo
How this form is used
What it may be used for
  • Used as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes
  • Xigduo XR is also approved to improve blood sugar control in children aged 10 and older with type 2 diabetes
  • The dapagliflozin component (in adults) reduces risks related to heart failure and chronic kidney disease progression
  • The dapagliflozin component (in adults) reduces the risk of hospitalization for heart failure in type 2 diabetes with cardiovascular disease or risk factors
Important instructions
  • Take once daily in the morning with food
  • Swallow the tablet whole — never crush, cut, or chew it
  • Xigduo XR: if you were taking an evening dose of metformin extended-release, skip that last dose before starting Xigduo XR
  • May need to be stopped before surgery, prolonged fasting, or imaging procedures using contrast dye — follow your doctor's guidance
Available strengths 5 strengths
2.5 mg / 1000 mg 5 mg / 500 mg 5 mg / 1000 mg 10 mg / 500 mg 10 mg / 1000 mg
60 FDA-listed product records ⓘ

📊 Dapagliflozin / Metformin across the U.S. market

How Dapagliflozin / Metformin 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 ⓘ
10
Manufacturers
3
Brand names
60
FDA-listed product records ⓘ
2014
First marketed ⓘ
AstraZeneca Pharmaceuticals LP50%
Novadoz Pharmaceuticals LLC7%
Macleods Pharmaceuticals Limited7%
Ascend Laboratories, LLC7%
Aurobindo Pharma Limited7%
Lupin Pharmaceuticals, Inc.7%
Other makers17%

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

📈 How widely Dapagliflozin / Metformin is used

A general measure of how commonly Dapagliflozin / Metformin 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 Dapagliflozin / Metformin 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.

40,800
Medicaid prescriptions filled (Q1–Q4 2025)
$30M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dapagliflozin / Metformin prescribed? Of the 1,596 medications we measure, Dapagliflozin / Metformin ranks #676 by Medicaid prescriptions — more than 58% of them.

Where Dapagliflozin / Metformin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #676 of 1,596
#671 Trospium 41,279 Rx #672 Tofacitinib 41,140 Rx #673 Gentamicin Topical 41,105 Rx #674 Carbinoxamine 40,978 Rx #675 Estradiol / Norethindr... 40,957 Rx #676 Dapagliflozin / Metfor... 40,800 Rx #677 Calcium Gluconate 40,321 Rx #678 Dutasteride 40,080 Rx #679 Granisetron 39,710 Rx #680 Acarbose 39,489 Rx #681 Carisoprodol 38,921 Rx

Utilization by Dapagliflozin / Metformin 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 5 mg / 1000 mg 24 hr extended release oral tablet is the most-dispensed Dapagliflozin / Metformin product — about 48% of these Medicaid prescriptions.

24 HR dapagliflozin 5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet Most dispensed

19,405 Medicaid prescriptions (Q1–Q4 2025) 48% of Dapagliflozin / Metformin prescriptions shown $13.1M gross reimbursement (before rebates) ≈ $677 per prescription (gross)

Summed across the 2 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1593070

24 HR dapagliflozin 10 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

17,102 Medicaid prescriptions (Q1–Q4 2025) 42% of Dapagliflozin / Metformin prescriptions shown $12.9M gross reimbursement (before rebates) ≈ $752 per prescription (gross)

Summed across the 2 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1593058

24 HR dapagliflozin 5 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

2,239 Medicaid prescriptions (Q1–Q4 2025) 5% of Dapagliflozin / Metformin prescriptions shown $2.3M gross reimbursement (before rebates) ≈ $1,020 per prescription (gross)

Summed across the 1 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1593072

24 HR dapagliflozin 10 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

1,523 Medicaid prescriptions (Q1–Q4 2025) 4% of Dapagliflozin / Metformin prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $881 per prescription (gross)

Summed across the 1 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1593068

24 HR dapagliflozin 2.5 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

531 Medicaid prescriptions (Q1–Q4 2025) 1% of Dapagliflozin / Metformin prescriptions shown $406,819 gross reimbursement (before rebates) ≈ $766 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1940496

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 Dapagliflozin / Metformin, 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 7 of 86 listed Dapagliflozin / Metformin NDCs with Medicaid activity.

🔍 Compare Dapagliflozin / Metformin products

A representative set of FDA-listed product records for Dapagliflozin / Metformin — 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 60 of 60 products — FDA National Drug Code Directory. See every product, package size and price: browse all 60 Dapagliflozin / Metformin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Dapagliflozin / Metformin RxCUI 1486436 1 dose form · 5 strengths

Look up RxCUI 1486436 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Xigduo Xr Xigduo

🏭 Manufacturers & labelers

AstraZeneca Pharmaceuticals LP 30 Novadoz Pharmaceuticals LLC 4 Macleods Pharmaceuticals Limited 4 Ascend Laboratories, LLC 4 Aurobindo Pharma Limited 4 Lupin Pharmaceuticals, Inc. 4 Golden State Medical Supply, Inc. 3 Sun Pharmaceutical Industries, Inc. 3 Prasco, Llc 2 Prasco Laboratories 2

RxNorm drug class

Dapagliflozin / Metformin belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works Sodium-Glucose Transporter 2 Inhibitors

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 Dec 20, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dapagliflozin / Metformin.
📈
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 Dapagliflozin / Metformin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
60
Distinct labelers/manufacturers represented
10
Linked representative label ⓘ
Prasco, Llc
Linked label effective
Dec 20, 2024
Composite sections available
24
Linked SPL Set ID
eaf135b6-e378-4f62-a1e7-db45e23668c7
Linked SPL Document ID
8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5
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 9 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. Prasco, Llc 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.