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DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10 mg; 500 mg Tablet, Film Coated, Extended Release, 30-count

by Novadoz Pharmaceuticals LLC · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-436-01)

NDC 72205-0436-01

🏷️ FDA NDC (as labeled) 72205-436-01 billing pads the product segment with a zero

This package

Contains30-count Cost per ea$0.8559 NADAC Per package$25.68 / 30 tablets Pack sizes2 compare ↓

Also priced by: Part D plans $1.27/unit — full pricing hub ↓

Also comes in: 500 tablets 72205-0436-02

Rx only Generic On market Non-controlled

🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 72205-436-01

Product NDC 72205-436

11-digit billing NDC 72205043601

NCPDP billing unit EA — each (per item)

RxCUI 1593058, 1593068, 1593070, 1593072

UNII 786Z46389E, 1ULL0QJ8UC

UPC 0372205437036, 0372205437029, 0372205435018, 0372205437012 +6 more

Application # ANDA211479

SPL Set ID 4f890458-be94-4baf-b606-83a097e1e23e

Established class (EPC) Sodium-Glucose Cotransporter 2 Inhibitor

Mechanism of action Sodium-Glucose Transporter 2 Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-04-06

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

GPI-14 27996002297530

GCN Seq No 073030

GCN 37342

HICL code 041188

Ingredient (HICL) Dapagliflozin/Metformin

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C4

Therapeutic class — intermediate (HIC2) Antihyperglycemics

HIC3 code C4E

Therapeutic class — specific (HIC3) Antihyperglycemic-Sglt2 Inhibitor-Biguanide Combs.

AHFS code 68:20.04.00

AHFS class Biguanides

FDB label name DAPAGLIFLOZIN-METFOR ER 10-500

FDB brand name Dapagliflozin-Metformin Er

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 72205-436-01 — 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 → 72205-0436-01. 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 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

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNovadoz Pharmaceuticals LLC

Application holderMSN LABORATORIES PRIVATE LTD

FDA applicationANDA211479 (ANDA)

Labeler code72205

First marketedApr 2026

Product typeHuman Prescription Drug

Portfolio246 products on file

🔎 All NDCs from Novadoz Pharmaceuticals LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DAPAGLIFLOZIN-METFOR ER 10-500 Ingredient Dapagliflozin/Metformin

📖 What it is MedlinePlus · NLM

Dapagliflozin is used to lower blood sugar in people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally). to reduce the risk of being hospitalized for heart failure in certain adults with type 2 diabetes to reduce the risk of being hospitalized for heart failure and death in adults with heart failure to reduce the risk of worsening of kidney disease, being hospitalized for heart failure, and death in certain adults with kidney disease Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SG...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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 uri...
What is this medication actually doing for me — is it just for blood sugar?
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 prob...
I heard metformin can cause a dangerous condition called lactic acidosis. Should I be worried?

📖 Read our full Dapagliflozin / Metformin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Pink / Brown

ShapeOval

ImprintMD4

Size2 mm

ScoringNot scored

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 K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 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.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.856	$25.68 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$1.27	$38.08 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 2% over the last 2 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Dapagliflozin and Metformin Hydrochloride 10 mg/1; 500 mg 63304-0027-30	Sun	30 tablets	$0.856	AB	Availability likely	—
Dapagliflozin And Metformin Hydrochloride 10 mg/1; 500 mg 70748-0103-06	Lupin	30 tablets	$0.856	AB	Availability likely	—
Dapagliflozin And Metformin Hydrochloride 10 mg/1; 500 mgthis 72205-0436-01	Novadoz	30 tablets	$0.856	AB	Availability likely	—
Xigduo Xr 10 mg/1; 500 mg 00310-6270-30	AstraZeneca	30 tablets	$19.226	AB	Availability likely	+2146%
Dapagliflozin and Metformin Hydrochloride 10 mg/1; 500 mg 33342-0407-06	Macleods	10 tablets	—	AB	FDA listed	—
Dapagliflozin and Metformin hydrochloride 10 mg/1; 500 mg 59651-0156-05	Aurobindo	500 tablets	—	AB	FDA listed	—
dapagliflozin and metformin hydrochloride 10 mg/1; 500 mg 67877-0621-05	Ascend	500 tablets	—	AB	FDA listed	—
Dapagliflozin and Metformin Hydrochloride 10 mg/1; 500 mg 84677-0021-30	Golden	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2026

First FDA approval

Apr 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2026. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Apr 6, 2026 AB TE-rated RLD RS

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

Exclusivity PC

2026

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.

FDA exclusivity

Code	What it grants	Expires
PC	Pediatric Exclusivity (+6 months)	Oct 3, 2026
PC	Pediatric Exclusivity (+6 months)	Oct 3, 2026
PC	Pediatric Exclusivity (+6 months)	Oct 3, 2026
PC	Pediatric Exclusivity (+6 months)	Oct 3, 2026

Common questions

Is there a generic version of DAPAGLIFLOZIN-METFOR ER 10-500?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for DAPAGLIFLOZIN-METFOR ER 10-500. See the alternatives section for substitutable, lower-cost products.

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.

🔬 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 DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Blood Glucose Increased230

Nausea222

Weight Decreased176

Diarrhoea175

Vomiting175

Diabetic Ketoacidosis165

Fatigue144

Age at onset

Adolescent1

Adult328

Elderly214

Reporter sex

Male · 52%

Female · 48%

Serious outcomes

Hospitalization1,129

Life-threatening243

Death218

Disabling75

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
72205-0436-01 You're viewing this	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-436-01)	$0.8559 / ea	$25.68	2026-04-09	Active
72205-0436-02	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-436-02)	—	—	2026-04-09	Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72205-0436-01?

NDC 72205-0436-01 is a 30-count package — 30 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 72205-0436-01 and NDC 72205-0436-02?

Both are DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10 mg; 500 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 72205-0436-01 is the 30-count package, while NDC 72205-0436-02 is the 500 tablets package.

What NDC number is used to bill for this package of DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10 mg; 500 mg Tablet, Film Coated, Extended Release?

Bill NDC 72205-0436-01 — the 11-digit billing format is 72205043601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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.

🚨 Boxed Warning 🎯 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning ~2 min read ▾

WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ] .

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information [ see D osage and Administration ( 2.1 and 2.4 ), Contraindications (4) , Warnings and Precautions (5.1) , Drug Interactions (7) , and Use in Specific Populations (8.6 , 8.7) ] .

If metformin-associated lactic acidosis is suspected, immediately discontinue dapagliflozin and metformin HCl extended-release and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1 )] . WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning.

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.

( 5.1) Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. ( 5.1 ) If lactic acidosis is suspected, discontinue dapagliflozin and metformin HCl extended-release and institute general supportive measures in a hospital setting.

Prompt hemodialysis is recommended. ( 5.1 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression.

Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use Dapagliflozin and metformin HCl extended-release tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ].

Because of the metformin HCl component, the use of dapagliflozin and metformin HCl extended-release tablets are limited to patients with type 2 diabetes mellitus for all indications. Dapagliflozin and metformin HCl extended-release tablets are not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. Dapagliflozin and metformin HCl extended-release tablets are not expected to be effective in these populations.

Pediatric use information is approved for AstraZeneca AB’s Xigduo® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information. Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

( 1 ) Dapagliflozin when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. ( 1 ) Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. ( 1 ) Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.

( 1 ) Limitations of use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Because of the metformin HCl component, the use of dapagliflozin and metformin HCl extended-release tablets are limited to patients with type 2 diabetes mellitus for all indications. ( 1 ) Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease.

Dapagliflozin and metformin HCl extended-release tablets are not expected to be effective in these populations. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Assess renal function prior to initiating and then as clinically indicated. ( 2.1 ) Assess volume status and correct volume depletion before initiating. ( 2.1 ) Individualize the starting dosage based on the patient’s current treatment.

( 2.3 ) Administer orally once daily in the morning with food. ( 2.2 ) To improve glycemic control, for patients not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. ( 2.3 ) For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily.

( 2.3 ) Do not exceed a daily dosage of 10 mg dapagliflozin/ 2,000 mg metformin HCl extended-release. ( 2.3 ) See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.4 ) Dapagliflozin and metformin HCl extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

( 2.5 ) Withhold Dapagliflozin and metformin HCl extended-release tablets for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.6 )

2.1Testing Prior to Initiation of Dapagliflozin and Metformin HCl Extended-Release Tablets Assess renal function prior to initiating dapagliflozin and metformin HCl extended-release tablets and then as clinically indicated [see Warnings and Precautions (5.1 , 5.3) ] . Assess volume status. In patients with volume depletion, correct this condition before initiating dapagliflozin and metformin HCl extended-release tablets [see Warnings and Precautions (5.3) and Use in Specific Populations (8.5 , 8.6) ] .

2.2Recommended Administration Take dapagliflozin and metformin HCl extended-release tablets orally once daily in the morning with food. Swallow dapagliflozin and metformin HCl extended-release tablets whole and never crush, cut, or chew.

2.3Recommended Dosage Individualize the starting dosage of dapagliflozin and metformin HCl extended-release tablets based upon the patient’s current regimen. Patients taking an evening dosage of metformin HCl extended-release should skip their last dose before starting dapagliflozin and metformin HCl extended-release tablets. To improve glycemic control in adult patients not already taking: Dapagliflozin: the recommended starting dosage of dapagliflozin in dapagliflozin and metformin HCl extended-release tablets is 5 mg orally once daily.

Metformin HCl extended-release: the recommended starting dosage of metformin HCl extended-release in dapagliflozin and metformin HCl extended-release tablets is 500 mg orally once daily. For dapagliflozin and metformin HCl extended-release tablets indications in adults related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin in dapagliflozin and metformin HCl extended-release tablets is 10 mg orally once daily. For all dapagliflozin and metformin HCl extended-release tablets indications, the dosage may be adjusted based on effectiveness and tolerability.

The maximum recommended daily dosage of dapagliflozin is 10 mg and 2,000 mg of metformin HCl extended-release, with gradual dosage escalation to reduce gastrointestinal adverse reactions with metformin HCl [see Adverse Reactions (6.1) ]. Pediatric use information is approved for AstraZeneca AB’s Xigduo ® XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4Recommended Dosage in Patients with Renal Impairment The recommended dosage of dapagliflozin and metformin HCl extended-release tablets in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. Initiation of dapagliflozin and metformin HCl extended-release tablets are not recommended in patients with an e…

💊 Dosage Forms and Strengths 153 words ▾

3 DOSAGE FORMS AND STRENGTHS Dapagliflozin and metformin HCl extended-release tablets are available as follows : 5 mg/500 mg tablets are light pink coloured, capsule shaped biconvex, film-coated tablets debossed with “MD6” on one side and plain on other side. 5 mg/1,000 mg tablets are light pink coloured, oval shaped, biconvex, film-coated tablets debossed with “MD5” on one side and plain on other side. 10 mg/500 mg tablets are brown coloured, capsule shaped, biconvex, film-coated tablets debossed with “MD7” on one side and plain on other side.

10 mg/1,000 mg tablets are brown coloured, oval shaped, biconvex, film-coated tablets debossed with “MD4” on one side and plain on other side. • 5 mg dapagliflozin/500 mg metformin HCl extended-release ( 3 ) • 5 mg dapagliflozin/1,000 mg metformin HCl extended-release ( 3 ) • 10 mg dapagliflozin/500 mg metformin HCl extended-release ( 3) • 10 mg dapagliflozin/1,000 mg metformin HCl extended-release ( 3 )

⛔ Contraindications 149 words ▾

4 CONTRAINDICATIONS Dapagliflozin and metformin HCl extended-release is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease [see Warnings and Precautions (5.1) ] . History of a serious hypersensitivity reaction to dapagliflozin, metformin HCl, or any of the excipients in dapagliflozin and metformin HCl extended-release. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions (6.1) ] .

Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1) and Warnings and Precautions (5.2) ] . Severe renal impairment (eGFR below 30 mL/min/1.73m 2 ) or end-stage renal disease.

( 4 ) History of serious hypersensitivity to dapagliflozin, metformin HCl, or any of the excipients in dapagliflozin and metformin HCl extended-release. ( 4 ) Metabolic acidosis, including diabetic ketoacidosis. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Lactic Acidosis : See boxed warning. ( 5.1 ) Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue dapagliflozin and metformin HCl extended-release if ketoacidosis is suspected.

Monitor patients for resolution of ketoacidosis before restarting.( 5.2 ) Volume Depletion: Before initiating dapagliflozin and metformin HCl extended-release, assess and correct volume status in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.3 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

( 5.4 ) Hypoglycemia: Consider a lower dosage of insulin or an insulin secretagogue to reduce the risk of hypoglycemia when used concomitantly with dapagliflozin and metformin HCl extended-release. ( 5.5 ) Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise.

If suspected, institute prompt treatment. ( 5.6 ) Vitamin B 12 Deficiency : Metformin may lower vitamin B 12 levels. Measure hematological parameters annually.

( 5.7 ) Genital Mycotic Infections : Monitor and treat if indicated. ( 5.8 )

5.1Lactic Acidosis There have been post-marketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate: pyruvate ratio; metformin plasma levels generally >5 mcg/mL.

Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk. If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of dapagliflozin and metformin HCl extended-release. In dapagliflozin and metformin HCl extended-release-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin HCl is dialyzable, with a clearance of up to 170 mL/min under good hemodynamic conditions).

Hemodialysis has often resulted in reversal of symptoms and recovery. Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur, instruct them to discontinue dapagliflozin and metformin HCl extended-release and report these symptoms to their healthcare provider. For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below: Renal Impairment: The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment.

The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient’s renal function include [s ee Dosage and Administration (2.1 , 2.4 ) and Clinical Pharmacology (12.3) ] : Before initiating dapagliflozin and metformin HCl extend…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2) ] Volume Depletion [see Warnings and Precautions (5.3) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.6) ] Vitamin B12 Concentrations [see Warnings and Precautions (5.7) ] Genital Mycotic Infections [see Warnings and Precautions (5.8) ] Adverse reactions reported in >5% of patients treated with dapagliflozin and metformin HCl extended-release were female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.

( 6.1 ) Adverse reactions reported in >5% of patients treated with metformin extended-release are: diarrhea and nausea/vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials with Metformin HCl Extended-Release in Adults with Type 2 Diabetes Mellitus In placebo-controlled monotherapy trials of metformin HCl extended-release, diarrhea and nausea/vomiting were reported in >5% of metformin-treated patients and more commonly than in placebo-treated patients (9.6% versus 2.6% for diarrhea and 6.5% versus 1.5% for nausea/vomiting).

Diarrhea led to discontinuation of study medication in 0.6% of the patients treated with metformin HCl extended-release. Clinical Trials with Dapagliflozin in Adults Dapagliflozin Dapagliflozin has been evaluated in clinical trials in adult patients with type 2 diabetes mellitus, in adult patients with heart failure, and in adult patients with chronic kidney disease. The overall safety profile of dapagliflozin was consistent across the studied indications.

No new adverse reactions were identified in the DAPA-HF, DELIVER and DAPA-CKD trials. Pools of Placebo-Controlled Clinical Trials for Glycemic Control in Adults Pool of 8 Placebo-Controlled Adult Trials for Dapagliflozin and Metformin HCl for Glycemic Control Data from a prespecified pool of adult patients from 8 short-term, placebo-controlled trials of dapagliflozin coadministered with metformin HCl immediate- or extended-release was used to evaluate safety. This pool included several add-on trials (metformin HCl alone and in combination with a dipeptidyl peptidase-4 [DPP4] inhibitor and metformin HCl , or insulin and metformin HCl, 2 initial combination with metformin HCl trials, and 2 trials of patients with CVD and type 2 diabetes mellitus who received their usual treatment [with metformin HCl as background therapy]).

For trials that included background therapy with and without metformin HCl, only patients who received metformin HCl were included in the 8-trial placebo-controlled pool. Across these 8 trials, 983 patients were treated once daily with dapagliflozin 10 mg and metformin HCl, and 1185 were treated with placebo and metformin HCl. These 8 trials provide a mean duration of exposure of 23 weeks.

The mean age of the population was 57 years and 2% were older than 75 years. Fifty-four percent (54%) of the population was male; 88% White, 6% Asian, and 3% Black or African American. At baseline, the population had diabetes for an average of 8 years, mean hemoglobin A1c (HbA1c) was 8.4%, and renal function was normal or mildly impaired in 90% of patients and moderatel…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 6: Clinically Relevant Interactions with Dapagliflozin and Metformin Hydrochloride Extended-Release Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs withdapagliflozin and metformin hydrochloride extended-release may increase the risk for lactic acidosis.

Intervention Consider more frequent monitoring of these patients. Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .

Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention Warn patients against excessive alcohol intake while receivingdapagliflozin and metformin hydrochloride extended-release .

Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased whendapagliflozin and metformin hydrochloride extended-release is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.5) ] . Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Drugs Affecting Glycemic Control Clinical Impact Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control.

These medications include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. Intervention When such drugs are administered to a patient receiving dapagliflozin and metformin hydrochloride extended-release , observe the patient closely for loss of blood glucose control. When such drugs are withdrawn from a patient receiving dapagliflozin and metformin hydrochloride extended-release , observe the patient closely for hypoglycemia.

Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Interventio n Monitor serum lithium concentration more frequently during dapagliflozin and metformin hydrochloride extended-release initiation and dosage changes. Positive Urine Glucose Test Clinical Impact SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests.

Intervention Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) Assay Clinical Impact Measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors.

Interventio n Monitoring glycemic control with 1,5-AG assay is not recommended. Use alternative methods to monitor glycemic control. Carbonic anhydrase inhibitors: May increase risk of lactic acidosis.

Consider more frequent monitoring. ( 7 ) Drugs that reduce metformin clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use.

( 7 ) See full prescribing information for additional drug interactions and information on interference of dapagliflozin and metformin HCl extended-release with laboratory tests.( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Advise females of the potential risk to a fetus, especially during the second and third trimesters. (8.1) Lactation: Not recommended when breastfeeding. (8.2) Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy.

(8.3) Geriatrics : Higher incidence of adverse reactions related to hypotension. Assess renal function more frequently. ( 8.5 , 8.6 ) Renal Impairment : Higher incidence of adverse reactions related to volume depletion.

( 8.6 ) Hepatic Impairment : Avoid use in patients with hepatic impairment. ( 8.7) Pediatric use information is approved for AstraZeneca AB’s Xigduo®XR (dapagliflozin and metformin hydrochloride) Extended-Release Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, dapagliflozin and metformin HCl extended-release is not recommended during the second and third trimesters of pregnancy. Limited data with dapagliflozin and metformin HCl extended-release or dapagliflozin in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see Data) .

There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see Data) . The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with HbA1c greater than 10%.

The estimated background risk of 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 Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. However, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups.

Animal Data Dapagliflozin Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on AUC). The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period.

🤰 Pregnancy ~3 min read ▾

In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC).

Dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on AUC). No adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on AUC). These outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development.

In embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. In rats, dapagliflozin was neither embryolethal nor teratogenic…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The use of dapagliflozin and metformin HCl extended-release for this indication is also supported by evidence from adequate and well-controlled trials of metformin HCl immediate-release tablets in adults with additional data from a controlled clinical trial using metformin HCl immediate-release tablets in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, and pharmacokinetic data with metformin HCl extended-release tablets in adults [see Clinical Pharmacology (12.3) and Clinical Studies (14.1 , 14.2) ] .

In the clinical trial with pediatric patients receiving metformin HCl immediate-release tablets, adverse reactions with metformin HCl immediate-release tablets were similar to those described in adults [see Adverse Reactions (6.1) ]. The safety and effectiveness of dapagliflozin and metformin HCl extended-release for glycemic control in patients with type 2 diabetes mellitus have not been established in pediatric patients less than 10 years of age. The safety and effectiveness of dapagliflozin and metformin HCl extended-release have not been established in pediatric patients to reduce the risk of [see Indications and Usage (1) ]: sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure. hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Dapagliflozin and metformin HCl extended-release No dapagliflozin and metformin HCl extended-release dosage change is recommended based on age. More frequent assessment of renal function is recommended in elderly patients. Dapagliflozin A total of 1424 (24%) of the 5936 dapagliflozin-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical trials assessing the efficacy of dapagliflozin in improving glycemic control.

After controlling for level of renal function (eGFR), efficacy was similar for patients under age 65 years and those 65 years and older. In patients ≥65 years of age, a higher proportion of patients treated with dapagliflozin for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ]. In the DAPA-HF, DELIVER and DAPA-CKD trials, safety and efficacy were similar for patients aged 65 years and younger and those older than 65 in both the overall population and in the patients with type 2 diabetes mellitus.

In the DAPA-HF trial, 2,714 (57%) out of 4,744 patients with heart failure with reduced ejection fraction (HFrEF) were older than 65 years. Out of 2,139 patients with HFrEF and type 2 diabetes mellitus, 1,211 (57%) were older than 65 years. In the DELIVER trial, 4759 (76%) out of 6263 patients with heart failure (LVEF >40%) were older than 65 years.

Out of 2806 patients with LVEF >40% and type 2 diabetes mellitus, 2072 (74%) were older than 65 years. In the DAPA-CKD trial, 1,818 (42%) out of 4,304 patients with chronic kidney disease were older than 65 years. Out of 2,906 patients with chronic kidney disease and type 2 diabetes mellitus, 1,399 (48%) were older than 65 years.

Metformin HCl Controlled clinical trials of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently than younger patients. In general, dosage selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients [see Warnings and Precautions (5.1) ].

🆘 Overdosage 101 words ▾

10 OVERDOSAGE Dapagliflozin In the event of an overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. The removal of dapagliflozin by hemodialysis has not been studied. Metformin HCl Overdose of metformin HCl has occurred, including ingestion of amounts >50 grams.

Lactic acidosis has been reported in approximately 32% of metformin overdose cases [ see Warnings and Precautions (5.1) ]. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dapagliflozin Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose, and thereby promotes urinary glucose excretion.

Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre-and afterload of the heart and downregulation of sympathetic activity, and decreased intraglomerular pressure which is believed to be mediated by increased tubuloglomerular feedback. Metformin HCl Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose.

Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may decrease.

12.2Pharmacodynamics General Dapagliflozin Increases in the amount of glucose excreted in the urine were observed in healthy subjects and in patients with type 2 diabetes mellitus following the administration of dapagliflozin (see Figure 1). Dapagliflozin doses of 5 or 10 mg per day in patients with type 2 diabetes mellitus for 12 weeks resulted in excretion of approximately 70 grams of glucose in the urine per day. A near maximum glucose excretion was observed at the dapagliflozin daily dosage of 20 mg.

This urinary glucose excretion with dapagliflozin also results in increases in urinary volume [ see Adverse Reactions (6.1)]. After discontinuation of dapagliflozin, on average, the elevation in urinary glucose excretion approaches baseline by about 3 days for the 10 mg dosage. Figure 1: Scatter Plot and Fitted Line of Change from Baseline in 24-Hour Urinary Glucose Amount versus Dapagliflozin Dose in Healthy Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM) (Semi-Log Plot) Cardiac Electrophysiology Dapagliflozin was not associated with clinically meaningful prolongation of QTc interval at daily doses up to 150 mg (15-times the recommended maximum dose) in a study of healthy subjects.

In addition, no clinically meaningful effect on QTc interval was observed following single doses of up to 500 mg (50-times the recommended maximum dose) of dapagliflozin in healthy subjects. figure-01

12.3Pharmacokinetics Dapagliflozin and metformin HCl extended-release The administration of dapagliflozin and metformin HCl extended-release in healthy subjects after a standard meal compared to the fasted state resulted in the same extent of exposure for both dapagliflozin and metformin extended-release. Compared to the fasted state, the standard meal resulted in 35% reduction and a delay of 1 to 2 hours in the peak plasma concentrations of dapagliflozin. This effect of food is not considered to be clinically meaningful.

Food has no relevant effect on the pharmacokinetics of metformin when administered as dapagliflozin and metformin HCl extended-release combination tablets. Absorption Dapagliflozin Following oral administration of dapagliflozin, the maximum plasma concentration (C max ) is usually attained within 2 hours under fasting state. The C max and AUC values increase dose proportionally with increase in dapagliflozin dose in the therapeutic dose range.

The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%. Administration of dapagliflozin with a high-fat meal decreases its C max by up to 50% and prolongs T max by approximately 1 hour, but does not alter AUC as compared with the fasted state. These changes…

🧬 Mechanism of Action 167 words ▾

📦 How Supplied / Storage and Handling 189 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dapagliflozin and metformin HCl extended-release tablets have markings on one side, are plain on the reverse side, and are available in the strengths and packages listed in Table 21. Table 21: Dapagliflozin and metformin HCl extended-release Tablet Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code 5/500 mg light pink, biconvex, capsule-shaped "MD6" debossed on one side and plain on the other side. Bottle of 30 Bottle of 500 72205-434-01 72205-434-02 5/1,000 mg light pink, biconvex, oval-shaped "MD5" debossed on one side and plain on the other side.

Bottle of 30 Bottle of 60 Bottle of 400 72205-435-01 72205-435-03 72205-435-02 10/500 mg brown coloured biconvex, capsule-shaped "MD7" debossed on one side and plain on the other side. Bottle of 30 Bottle of 500 72205-436-01 72205-436-02 10/1,000 mg brown coloured biconvex, oval-shaped "MD4" debossed on one side and plain on the other side. Bottle of 30 Bottle of 60 Bottle of 400 72205-437-01 72205-437-03 72205-437-02 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP. Dapagliflozin Dapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C 21 H 25 ClO 6 and the formula weight is 408.88.

The structural formula is: Metformin hydrochloride USP Metformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C 4 H 11 N 5 .HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pK a of metformin is 2.8 and 11.5.

The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is: Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg).

Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black. dapa-met-dapagliflozin-structure dapa-met-metformin-structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Lactic Acidosis Inform patients of the risks of lactic acidosis due to the metformin component and its symptoms and conditions that predispose to its development [ see Warnings and Precautions (5.1) ]. Advise patients to discontinue dapagliflozin and metformin HCl extended-release immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow or irregular heartbeat, sensation of feeling cold (especially in the extremities), or other nonspecific symptoms occur.

Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of dapagliflozin and metformin HCl extended-release therapy; however, inform patients to consult their physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be evaluated to determine if it may be due to lactic acidosis or other serious disease. Counsel patients against excessive alcohol intake while receiving dapagliflozin and metformin HCl extended-release [see Warnings and Precautions (5.1) ].

Inform patients about the importance of regular testing of renal function and hematological parameters when receiving treatment with dapagliflozin and metformin HCl extended-release [ see Contraindications (4) and Warnings and Precautions (5.1) ]. Instruct patients to inform their healthcare provider that they are taking dapagliflozin and metformin HCl extended-release prior to any surgical or radiological procedure, as temporary discontinuation of dapagliflozin and metformin HCl extended-release may be required until renal function has been confirmed to be normal [ see Warnings and Precautions (5.1) ] .

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis Inform patients that dapagliflozin and metformin HCl extended-release can cause potentially fatal ketoacidosis and that type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are risk factors. Educate all patients on precipitating factors (such as insulin dose reduction or missed insulin doses, infection, reduced caloric intake, ketogenic diet, surgery, dehydration, and alcohol abuse) and symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing).

Inform patients that blood glucose may be normal even in the presence of ketoacidosis. Advise patients that they may be asked to monitor ketones. If symptoms of ketoacidosis occur, instruct patients to discontinue dapagliflozin and metformin HCl extended-release and seek medical attention immediately [see Warnings and Precautions (5.2) ] .

Volume Depletion Inform patients that symptomatic hypotension may occur with dapagliflozin and metformin HCl extended-release and advise them to contact their healthcare provider if they experience such symptoms [ see Warnings and Precautions (5.3) ]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake. Serious Urinary Tract Infections Inform patients of the potential for urinary tract infections, which may be serious.

Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice promptly if such symptoms occur [ see Warnings and Precautions (5.4) ]. Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues Inform patients that the incidence of hypoglycemia may increase when dapagliflozin and metformin HCl extended-release is added to an insulin secretagogue (e.g., sulfonylurea) and/ or insulin.

Educate patients on the signs and symptoms of hypoglycemia [ see Warnings and Precautions (5.5) ] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Inform patients that necrotiz…

Glossary — plain-language definitions of medical terms used in this label:

antihyperglycemic: Describes a medicine that lowers blood sugar.

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressive: Describes something that lowers the activity of the immune system.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

abuse: Using a medicine in a way it was not meant to be used, such as taking more than prescribed to feel a high.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diabetic ketoacidosis: A serious condition, mainly in people with diabetes, where the blood turns acidic because the body burns fat instead of sugar for energy.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

ejection fraction: The share of blood in the heart's main pumping chamber that gets pushed out with each beat, given as a percentage.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

lactic acidosis: A buildup of a waste product called lactic acid in the blood, which makes the blood too acidic.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

monotherapy: Treatment using a single medicine by itself.

myalgia: Muscle pain or aching.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

stillbirth: The death of a baby in the womb late in pregnancy or during birth.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

transporter: A protein that moves drugs across cell membranes, carrying them either into or out of cells.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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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.

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10 mg; 500 mg Tablet, Film Coated, Extended Release, 30-count

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