Home › NDC Lookup › Ingredients › Dapagliflozin And Metformin Hydrochlorid... › 63304-0026-30
Dapagliflozin and Metformin Hydrochloride 5 mg; 1000 mg Tablet, Film Coated, Extended Release, 30-count — NDC 63304-0026-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dapagliflozin and Metformin Hydrochloride 5 mg; 1000 mg Tablet, Film Coated, Extended Release, 30-count — NDC 63304-026-30 (Billing 63304-0026-30)

by Sun Pharmaceutical Industries, Inc. · 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 tablets of Dapagliflozin and Metformin Hydrochloride 5 mg; 1000 mg Tablet, Film Coated, Extended Release from Sun Pharmaceutical Industries, Inc., marketed since Apr 2026 and currently FDA-listed.

NDC 63304-0026-30
🏷️ FDA NDC (as labeled) 63304-026-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $1.27/unit — full pricing hub ↓
Product page 63304-0026-62 Also comes in: 60 tablets 63304-026-62 400 tablets 63304-026-54
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63304-026-30
Product NDC 63304-026
11-digit billing NDC 63304002630
Application # ANDA211491
SPL Set ID bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a
Established class (EPC) Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of action Sodium-Glucose Transporter 2 Inhibitors
Chemical class Biguanides
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
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 073031
GCN 37343
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 5-1000
FDB brand name Dapagliflozin-Metformin Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073031
  • GCN: 37343
  • HICL (First Databank): 041188
  • AHFS class code: 68:20.04.00
Why two NDCs? The FDA registers this code as 63304-026-30 — 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 → 63304-0026-30. 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.

Clinical

Label name DAPAGLIFLOZIN-METFOR ER 5-1000 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 helps control blood sugar in type 2 diabetes, along with diet and exercise. The dapagliflozin part can also lower your risk of heart failure hospitalization and kidney disease g...
  • Take it once a day in the morning with food, and swallow it whole. Don't crush, cut or chew it. Follow the dose your prescriber gave you.
  • Some people get genital yeast infections, urinary infections, diarrhea, nausea, headache or more frequent urination. Tell your provider if these bother you or persist. Good hygiene...
  • Stop it and get medical help if you have unusual muscle pain, trouble breathing, extreme sleepiness, stomach pain with nausea or vomiting, or feel very unwell. These can signal lac...
📖 Read our full Dapagliflozin / Metformin guide →

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.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

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

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
63304-0026-30 You're viewing this 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2026-04-06 — Active
63304-0026-54 63304-026-54 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE — — 2026-04-06 — Active
63304-0026-62 63304-026-62 Main listing 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE $0.4606 / ea $27.64 2026-04-06 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet, film coated, extended release in 1 bottle.
How does this package differ from NDC 63304-0026-62?
Both are Dapagliflozin and Metformin Hydrochloride 5 mg; 1000 mg Tablet, Film Coated, Extended Release — the drug itself is identical. This page's package is the 30-count one, while NDC 63304-0026-62 is the 60 tablets package.
What NDC number is used to bill for this package of Dapagliflozin and Metformin Hydrochloride 5 mg; 1000 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
dapagliflozin and metformin hydrochloride 5 mg/1; 1000 mg 66993-0361-60 Prasco 60 tablets $0.461 AB Availability likely —
Dapagliflozin And Metformin Hydrochloride 5 mg/1; 1000 mg 70748-0102-07 Lupin 60 tablets $0.461 AB Availability likely —
Xigduo Xr 5 mg/1; 1000 mg 00310-6260-60 AstraZeneca 60 tablets $9.592 AB Availability likely —
Dapagliflozin and Metformin Hydrochloride 5 mg/1; 1000 mg 33342-0408-06 Macleods 10 tablets — AB FDA listed —
Dapagliflozin and Metformin hydrochloride 5 mg/1; 1000 mg 59651-0155-04 Aurobindo 400 tablets — AB FDA listed —
Dapagliflozin and Metformin Hydrochloride 5 mg/1; 1000 mgthis 63304-0026-30 Sun 30 tablets — AB FDA listed —
dapagliflozin and metformin hydrochloride 5 mg/1; 1000 mg 67877-0620-30 Ascend 30 tablets — AB FDA listed —
Dapagliflozin And Metformin Hydrochloride 5 mg/1; 1000 mg 72205-0435-01 Novadoz 30 tablets — AB FDA listed —
Dapagliflozin and Metformin Hydrochloride 5 mg/1; 1000 mg 84677-0020-60 Golden 60 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
Exclusivity PC
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
CodeWhat it grantsExpires
PCPediatric Exclusivity (+6 months)Oct 3, 2026
PCPediatric Exclusivity (+6 months)Oct 3, 2026
PCPediatric Exclusivity (+6 months)Oct 3, 2026
Common questions
Is there a generic version of DAPAGLIFLOZIN-METFOR ER 5-1000?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for DAPAGLIFLOZIN-METFOR ER 5-1000. 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.

What it looks like

Color pink / yellow
ShapeOval
ImprintRL;61
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII VM7F0B23ZI
    Hypromellose 2208 is a plant-derived thickening agent that forms a protective coating on tablets and capsules. It slows down how quickly the medicine dissolves, controlling drug release into your body.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII X7XJ6RM9Q2
    A plant-derived cellulose processed into tiny crystals. It acts as a binder and filler to give the tablet or capsule structure and helps the medicine break apart properly in your stomach.
  • 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 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.

16 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA211491 (ANDA)
Labeler code63304
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio890 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 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 non-specific 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 Dosage 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride component, the use of dapagliflozin and metformin hydrochloride extended-release tablets is limited to patients with type 2 diabetes mellitus for all indications. Dapagliflozin and metformin hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets are 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 hydrochloride 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 hydrochloride component, the use of dapagliflozin and metformin hydrochloride extended-release tablets is 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 hydrochloride extended-release tablets are not expected to be effective in these populations. ( 1 )

⏱️ Dosage and Administration ~2 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 hydrochloride extended-release. ( 2.3 ) See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.4 ) Dapagliflozin and metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

( 2.5 ) Withhold dapagliflozin and metformin hydrochloride 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 Hydrochloride Extended-Release Tablets Assess renal function prior to initiating dapagliflozin and metformin hydrochloride 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 hydrochloride 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 hydrochloride extended-release tablets orally once daily in the morning with food. Swallow dapagliflozin and metformin hydrochloride extended-release tablets whole and never crush, cut, or chew.

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

Metformin hydrochloride extended-release: the recommended starting dosage of metformin hydrochloride extended-release in dapagliflozin and metformin hydrochloride extended-release tablets is 500 mg orally once daily. For dapagliflozin and metformin hydrochloride extended-release tablets indications in adults related to heart failure and chronic kidney disease, the recommended dosage of dapagliflozin in dapagliflozin and metformin hydrochloride extended-release tablets is 10 mg orally once daily. For all dapagliflozin and metformin hydrochloride 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 hydrochloride extended-release, with gradual dosage escalation to reduce gastrointestinal adverse reactions with metformin hydrochloride [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 hydrochloride extended-release tablets in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 126 words ▾

3 DOSAGE FORMS AND STRENGTHS Dapagliflozin and metformin hydrochloride extended-release tablets are available as follows: 5 mg/1,000 mg tablets are pink to dark pink, biconvex, oval-shaped, film-coated tablets debossed with “ RL 59 ” on one side and plain on the reverse side. 10 mg/500 mg tablets are pink, biconvex, oval-shaped, film-coated tablets debossed with “ RL 60 ” on one side and plain on the reverse side. 10 mg/1,000 mg tablets are yellow to dark yellow, biconvex, oval-shaped, film-coated tablets debossed with “ RL 61 ” on one side and plain on the reverse side.

5 mg dapagliflozin/1,000 mg metformin hydrochloride extended-release ( 3 ) 10 mg dapagliflozin/500 mg metformin hydrochloride extended-release ( 3 ) 10 mg dapagliflozin/1,000 mg metformin hydrochloride extended-release ( 3 )

⛔ Contraindications 153 words ▾

4 CONTRAINDICATIONS Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride, or any of the excipients in dapagliflozin and metformin hydrochloride extended-release tablets. 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/1.73 m 2 ) or end-stage renal disease.

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

⚠️ Warnings and Cautions ~2 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 hydrochloride extended-release tablets if ketoacidosis is suspected.

Monitor patients for resolution of ketoacidosis before restarting. ( 5.2 ) Volume Depletion: Before initiating dapagliflozin and metformin hydrochloride extended-release tablets, 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 hydrochloride extended-release tablets. ( 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 non-specific 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 hydrochloride extended-release tablets. In dapagliflozin and metformin hydrochloride extended-release tablets treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride 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 hydrochloride extended-release tablets 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 [see Dosage and Adm… [Excerpted — this section continues on DailyMed.]

🤒 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 B 12 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 hydrochloride extended-release tablets 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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 o r 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 Hydrochloride Extended-Release in Adults with Type 2 Diabetes Mellitus In placebo-controlled monotherapy trials of metformin hydrochloride 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 hydrochloride 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 Hydrochloride for Glycemic Control Data from a prespecified pool of adult patients from 8 short-term, placebo-controlled trials of dapagliflozin coadministered with metformin hydrochloride immediate- or extended-release was used to evaluate safety. This pool included 2 initial combination with metformin hydrochloride trials.

Across these 8 trials, 983 patients were treated once daily with dapagliflozin 10 mg and metformin hydrochloride, and 1,185 were treated with placebo and metformin hydrochloride. 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 moderately impaired in 10% of patients. The overall incidence of adverse events for the 8-trial, short-term, placebo-controlled pool in adult patients treated with dapagliflozin 10 mg and metformin hydrochloride was 60.3% compared to 58.2% for the placebo and metformin hydrochloride group.

Discontinuation of therapy due to adverse events in patients who received dapag… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 6: Clinically Relevant Interactions with Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets 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 with dapagliflozin and metformin hydrochloride extended-release tablets 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 receiving dapagliflozin and metformin hydrochloride extended-release tablets.

Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when dapagliflozin and metformin hydrochloride extended-release tablets are 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 tablets, 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 tablets, observe the patient closely for hypoglycemia.

Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during dapagliflozin and metformin hydrochloride extended-release tablets 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.

Intervention 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets are not recommended during the second and third trimesters of pregnancy. Limited data with dapagliflozin and metformin hydrochloride extended-release tablets 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 embryofetal 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.

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. Increas… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 102 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 hydrochloride Overdose of metformin hydrochloride 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 hydrochloride 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 1

12.3Pharmacokinetics Dapagliflozin and metformin hydrochloride extended-release tablets The administration of dapagliflozin and metformin hydrochloride extended-release tablets 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 hydrochloride 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 alt… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 208 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Dapagliflozin and metformin hydrochloride 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 2 1: Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code 5 mg /1,000 mg pink to dark pink, biconvex, oval-shaped debossed with " RL 59 " on one side and plain on the reverse side.

Bottle of 30 (with child-resistant closure) 63304-026-30 Bottle of 60 (with child-resistant closure) 63304-026-62 Bottle of 400 63304-026-54 10 mg /500 mg pink, biconvex, oval-shaped debossed with " RL 60 " on one side and plain on the reverse side. Bottle of 30 (with child-resistant closure) 63304-027-30 Bottle of 400 63304-027-54 10 mg /1,000 mg yellow to dark yellow, biconvex, oval-shaped debossed with " RL 61 " on one side and plain on the reverse side Bottle of 30 (with child-resistant closure) 63304-028-30 Bottle of 400 63304-028-54 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.] Keep out of reach of children.

📋 Description ~1 min read ▾

11 DESCRIPTION Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a biguanide. Dapagliflozin Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C -[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S )-. The molecular formula is C 21 H 25 ClO 6 and the molecular weight is 408.87.

The structural formula is: Dapagliflozin is a white to off-white powder or solid. Dapagliflozin is slightly soluble in water, soluble in ethanol and freely soluble in dimethylsulfoxide. Metformin hydrochloride, USP Metformin hydrochloride, USP is described chemically as N,N -dimethylimidodicarbonimidic diamide hydrochloride is a white crystalline powder with a molecular formula of C 4 H 11 N 5 .HCl and a molecular weight of 165.62.

Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.37 to 6.53.

The structural formula is: Dapagliflozin and M etformin H ydrochloride Extended-Release Tablets Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as film-coated tablet containing 5 mg dapagliflozin and 1000 mg metformin hydrochloride, USP for dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg, 10 mg dapagliflozin and 500 mg metformin hydrochloride, USP for dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg, 10 mg dapagliflozin and 1000 mg metformin hydrochloride, USP for dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg, and the following inactive ingredients: anhydrous lactose, carboxymethyl cellulose sodium, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

The film coatings contain the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contain ferric oxide red and ferric oxide yellow, 10 mg/500 mg contains ferrosoferric oxide and ferric oxide red and 10 mg/1000 mg tablets contains ferric oxide yellow. Dapagliflozin Structural formula Metformin HCl structural formula

💬 Information for Patients ~2 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets [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 hydrochloride extended-release tablets [see Contraindications (4) and Warnings and Precautions (5.1) ] . Instruct patients to inform their healthcare provider that they are taking dapagliflozin and metformin hydrochloride extended-release tablets prior to any surgical or radiological procedure, as temporary discontinuation of dapagliflozin and metformin hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets and seek medical attention immediately [see Warnings and Precautions (5.2) ] .

Volume Depletion Inform patients that symptomatic hypotension may occur with dapagliflozin and metformin hydrochloride extended-release tablets 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 hydrochloride extended-release tablets are added to an insulin secretagogue (e.g., sulfonylurea) and/or insulin.

Educate… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE dapagliflozin (dap a gli FLOE zin) and metformin (met FOR min) hydrochloride (hye droe klor ide) extended-release tablets, for oral use What is the most important information I should know about dapagliflozin and metformin hydrochloride extended-release tablets? Dapagliflozin and metformin hydrochloride extended-release tablets can cause serious side effects, including: Lactic Acidosis . Metformin, one of the medicines in dapagliflozin and metformin hydrochloride extended-release tablets, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death.

Lactic acidosis is a medical emergency and must be treated in the hospital. Stop taking dapagliflozin and metformin hydrochloride extended-release tablets and call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis: you feel cold in your hands or feet you feel dizzy or lightheaded you have a slow or irregular heartbeat you feel very weak or tired you have unusual (not normal) muscle pain you have trouble breathing you feel unusual sleepiness or sleep longer than usual you have stomach pains, nausea or vomiting Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis.

Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with dapagliflozin and metformin hydrochloride extended-release tablets if you: have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye. have liver problems. drink alcohol very often or drink a lot of alcohol in the short-term ("binge" drinking). get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea.

Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids. have surgery. have new or worsening symptoms of congestive heart failure such as shortness of breath or increased fluid or swelling of the legs. have a heart attack, severe infection, or stroke. are 65 years of age or older. The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your dapagliflozin and metformin hydrochloride extended-release tablets for a while if you have any of these things.

Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Dapagliflozin and metformin hydrochloride extended-release tablets can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital.

People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery or a procedure that requires not having food for a long time (prolonged fasting).

Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking dapagliflozin and metformin hydrochloride extended-release tablets and call your healthcare provider or get medical help right away if you get any of the following.

If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL. nausea vomiting stomach area (abdominal) pain tiredness trouble br… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Glycemic Control Trials in Adults with Type 2 Diabetes Mellitus The effectiveness of dapagliflozinandmetformin hydrochloride extended-release tablets has been established in clinical trials of the coadministration of oral dapagliflozin and metformin hydrochloride extended-release tablets in treatment-naive adult patients inadequately controlled on diet and exercise alone. Treatment with dapagliflozin plus metformin hydrochloride at all doses produced statistically significant improvements in HbA1c and fasting plasma glucose (FPG) compared to placebo in combination with metformin hydrochloride (initial).

HbA1c reductions were seen across subgroups including gender, age, race, duration of disease, and baseline body mass index (BMI). Dapagliflozin Initial Combination Therapy with Metformin Hydrochloride Extended-Release A total of 1236 treatment-naive adult patients with inadequately controlled type 2 diabetes mellitus (HbA1c ≥ 7.5% and ≤ 12%) participated in 2 active-controlled trials of 24 week duration to evaluate initial therapy with dapagliflozin 5 mg ( NCT00643851 ) or 10 mg ( NCT00859898 ) in combination with metformin extended-release formulation.) or 10 mg ( NCT00859898 ) in combination with metformin extended-release formulation.

In one trial, 638 patients randomized to 1 of 3 treatment arms following a 1-week lead-in period received: dapagliflozin 10 mg plus metformin hydrochloride extended-release (up to 2,000 mg/day), dapagliflozin 10 mg plus placebo, or metformin hydrochloride extended-release (up to 2,000 mg/day) plus placebo. Metformin hydrochloride extended-release dosage was up-titrated weekly in 500 mg increments, as tolerated, with a median dosage achieved of 2,000 mg. The combination treatment of dapagliflozin 10 mg plus metformin hydrochloride extended-release provided statistically significant improvements in HbA1c and FPG compared with either of the monotherapy treatments and statistically significant reduction in body weight compared with metformin hydrochloride extended-release alone (see Table 11 and Figure 2).

Dapagliflozin 10 mg as monotherapy also provided statistically significant improvements in FPG and statistically significant reduction in body weight compared with metformin hydrochloride alone and was non-inferior to metformin hydrochloride extended-release monotherapy in lowering HbA1c. Table 11: Results at Week 24 (LOCF * ) in an Active-Controlled Trial of Dapagliflozin Initial Combination Therapy with Metformin Hydrochloride Extended-Release in Adults with Type 2 Diabetes Mellitus Efficacy Parameter Dapagliflozin 10 mg + Metformin Hydrochloride extended-release N = 211 † Dapagliflozin 10 mg N = 219 † Metformin Hydrochloride extended-release N = 208 † HbA1c (%) Baseline (mean) 9.1 9 9 Change from baseline (adjusted mean ‡ ) −2 −1.5 −1.4 Difference from dapagliflozin (adjusted mean ‡ ) (95% CI) −0.5 § (−0.7, −0.3) Difference from metformin hydrochloride extended-release (adjusted mean ‡ ) (95% CI) −0.5 § (−0.8, −0.3) 0 ¶ (−0.2, 0.2) Percent of patients achieving HbA1c <7% adjusted for baseline 46.6% 31.7% 35.2% FPG (mg/dL) Baseline (mean) 189.6 197.5 189.9 Change from baseline (adjusted mean ‡ ) −60.4 −46.4 −34.8 Difference from dapagliflozin (adjusted mean ‡ ) (95% CI) −13.9 § (−20.9, −7) Difference from metformin hydrochloride extended-release (adjusted mean ‡ ) (95% CI) −25.5 § (−32.6, −18.5) −11.6 # (−18.6, −4.6) Body Weight (kg) Baseline (mean) 88.6 88.5

87.2Change from baseline (adjusted mean ‡ ) −3.3 −2.7 −1.4 Difference from metformin hydrochloride extended-release (adjusted mean ‡ ) (95% CI) −2 § (−2.6, −1.3) −1.4 § (−2, −0.7) * LOCF: last observation (prior to rescue for rescued patients) carried forward. † All randomized patients who took at least one dose of double-blind trial medication during the short-term double-blind period. ‡ Least squares mean adjusted for baseline value. § p-value < 0.0001. ¶ Non-inferior versus metformin hydrochloride extended-rele… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dapagliflozin and metformin hydrochloride extended-release tablets No animal studies have been conducted with dapagliflozin and metformin hydrochloride extended-release tablets to evaluate carcinogenesis, mutagenesis, or impairment of fertility. The following data are based on the findings in the studies with dapagliflozin and metformin individually. Dapagliflozin Dapagliflozin did not induce tumors in either mice or rats at any of the doses evaluated in 2 year carcinogenicity studies.

Oral doses in mice consisted of 5, 15, and 40 mg/kg/day in males and 2, 10 and 20 mg/kg/day in females, and oral doses in rats were 0.5, 2, and 10 mg/kg/day for both males and females. The highest doses evaluated in mice were approximately 72-times (males) and 105-times (females) the clinical dose of 10 mg per day, based on AUC exposure. In rats, the highest dose was approximately 131-times (males) and 186-times (females) the clinical dose of 10 mg per day, based on AUC exposure.

Dapagliflozin was negative in the Ames mutagenicity assay and was positive in a series of in vitro clastogenicity assays in the presence of S9 activation and at concentrations greater than or equal to 100 mcg/mL. Dapagliflozin was negative for clastogenicity in a series of in vivo studies evaluating micronuclei or DNA repair in rats at exposure multiples greater than 2100-times the clinical dose. There was no carcinogenicity or mutagenicity signal in animal studies, suggesting that dapagliflozin does not represent a genotoxic risk to humans.

Dapagliflozin had no effects on mating, fertility, or early embryonic development in treated male or female rats at exposure multiples less than or equal to 1708-times and 998-times the maximum recommended human dose in males and females, respectively. Metformin hydrochloride Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 and 1,500 mg/kg/day, respectively. These doses are both approximately 4-times the maximum recommended human dose of 2,000 mg based on body surface area comparisons.

No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.

There was no evidence of a mutagenic potential of metformin in the following in vitro tests: Ames test ( S. typhimurium ), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the in vivo mouse micronucleus test were also negative. Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately 3-times the maximum recommended human dose based on body surface area comparisons.

📄 Package Label / Principal Display Panel 126 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 63304-026-62 Dapagliflozin and Metformin HCl Extended-Release Tablets 5 mg/1000 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient Do not crush, cut, or chew tablets. Tablets must be swallowed whole. Rx only 60 Tablets DapaMet Label-5mg1000mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 63304-027-30 Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/500 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient Do not crush, cut, or chew tablets. Tablets must be swallowed whole. Rx only 30 Tablets DapaMet Label-10mg500mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 63304-028-30 Dapagliflozin and Metformin HCl Extended-Release Tablets 10 mg/1000 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient Do not crush, cut, or chew tablets. Tablets must be swallowed whole. Rx only 30 Tablets DapaMet Label-10mg1000mg

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

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 tablets (63304-0026-62), 400 tablets (63304-0026-54). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63304-0018-05 · Sun 63304-0027-30 · Sun →
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.