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FARXIGA DAPAGLIFLOZIN 5 mg Tablet, Film Coated, 7-count — NDC 00310-6205-95 package photo

FARXIGA DAPAGLIFLOZIN 5 mg Tablet, Film Coated, 7-count

by AstraZeneca Pharmaceuticals LP · 1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK
NDC 00310-6205-95
🏷️ FDA NDC (as labeled) 0310-6205-95 billing pads the labeler segment with a zero
This package
Contains7-count Pack sizes3 compare ↓
Also priced by: Part D plans $6.05/unit — full pricing hub ↓
Also comes in: 30 tablets 00310-6205-30 90 tablets 00310-6205-90
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 0310-6205-95
Product NDC 0310-6205
11-digit billing NDC 00310620595
NCPDP billing unit EA — each (per item)
UNII 887K2391VH
Application # NDA202293
SPL Set ID 72ad22ae-efe6-4cd6-a302-98aaee423d69
Established class (EPC) Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of action Sodium-Glucose Transporter 2 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-01-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance DAPAGLIFLOZIN PROPANEDIOL
GCN Seq No 071740
GCN 35698
HICL code 040137
Ingredient (HICL) Dapagliflozin
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4D
Therapeutic class — specific (HIC3) Antihyperglycemic-Sod/Gluc Cotransport2(Sglt2) Inh
AHFS code 68:20.18.00
AHFS class Sodium-Gluc Cotransport 2 (Sglt2) Inhib
FDB label name FARXIGA 5 MG TABLET
FDB brand name Farxiga
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 0310-6205-95 — a 4-4-2 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 labeler segment → 00310-6205-95. 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.

🏭 Manufacturer & labeler

LabelerAstraZeneca Pharmaceuticals LP
Application holderASTRAZENECA AB
FDA applicationNDA202293 (NDA)
Labeler code00310
First marketedJan 2008
Product typeHuman Prescription Drug
Portfolio113 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.

🩺 Clinical

Label name FARXIGA 5 MG TABLET Ingredient Dapagliflozin
📗 Our plain-language guide HelloPharmacist
  • No, it's used for more than just blood sugar control. Dapagliflozin is approved to help manage type 2 diabetes, but it's also used to reduce the risk of serious heart failure compl...
  • What is dapagliflozin actually used for — is it just for diabetes?
  • You can take it either way — with or without food. A high-fat meal may slow how quickly it absorbs slightly, but it doesn't change the overall amount that gets into your system. Ju...
  • Can I take this tablet with food, or does it have to be on an empty stomach?
📖 Read our full Dapagliflozin guide →
1
Nutrient depletion considerations

Dapagliflozin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dapagliflozin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
ShapeDiamond
Imprint10;1428
Size11 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 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 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 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.

5 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 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 $6.05 $42.37 / 7 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dapagliflozin 5 mg 00480-3527-05 Teva 500 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 27241-0151-01 Ajanta 30 tablets $0.185 AB Availability likely —
dapagliflozin 5 mg 33342-0585-07 Macleods 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 59651-0159-30 Aurobindo 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 60505-4911-03 Apotex 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 62332-0392-30 Alembic 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 66993-0456-30 Prasco 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 69097-0388-02 Cipla 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 70710-1380-03 Zydus 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 70748-0105-06 Lupin 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 70954-0856-10 ANI 30 tablets $0.185 AB Availability likely —
Dapagliflozin 5 mg 72205-0432-01 Novadoz 30 tablets $0.185 AB Availability likely —
Farxiga 5 mgthis 00310-6205-95 AstraZeneca 7 tablets — AB FDA listed —
Dapagliflozin 5 mg 00781-5985-01 Sandoz 100 tablets — AB FDA listed —
Dapagliflozin 5 mg 46708-0392-30 Alembic 30 tablets — AB FDA listed —
Farxiga 5 mg 50090-3482-00 A-S 30 tablets — AB FDA listed —
Dapagliflozin 5 mg 50090-7056-00 A-S 30 tablets — AB FDA listed —
Dapagliflozin 5 mg 50090-7971-00 A-S 30 tablets — AB FDA listed —
Dapagliflozin 5 mg 67877-0608-05 Ascend 500 tablets — AB FDA listed —
Dapagliflozin 2,3-BUTANEDIOL MONOHYDRATE 5 mg 70377-0023-11 Biocon 30 tablets — AB FDA listed —
Farxiga 5 mg 70518-4614-00 REMEDYREPACK 1 tablet — AB FDA listed —
Dapagliflozin 5 mg 70771-1714-03 Zydus 30 tablets — AB FDA listed —
Dapagliflozin 5 mg 71921-0420-09 Florida 90 tablets — AB FDA listed —
Dapagliflozin 5 mg 73190-0072-30 AvKARE 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2014
First FDA approval
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 8, 2014 AB TE-rated RLD RS ⏳ ~15 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 8685934 — method of use (U-1522)
US 8906851 — method of use (U-2139)
US 8329648 — method of use (U-2213)
US 8329648 — method of use (U-2139)
US 8329648 — method of use (U-2139)
US 6515117 — drug substance (U-493)
US 8361972 — method of use (U-2139)
US 8361972 — method of use (U-2139)
US 6515117 — drug substance (U-2139)
US 8501698 — method of use (U-493)
US 8501698 — method of use (U-493)
US 8685934 — method of use (U-1522)
US 8361972 — method of use (U-493)
US 8329648 — method of use (U-2212)
US 8361972 — method of use (U-493)
US 8329648 — method of use (U-2212)
US 8906851 — method of use (U-2139)
US 10973836 — method of use (U-3127)
US 12213988 — method of use (U-4140)
US 12409186 — method of use (U-4140)
US 12472194 — method of use (U-4346)
US 8329648 — method of use (U-2213)
US 11826376 — method of use (U-3766)
US 11903955 — method of use (U-3825)
US 6515117 — drug substance (U-2139)
US 6515117 — drug substance (U-493)
US 7851502 — drug product
US 8721615 — drug product
US 8221786 — drug product
US 7919598 — drug substance
US 8221786 — drug product
US 8716251 — drug product
US 7851502 — drug product
US 8721615 — drug product
US 7919598 — drug substance
US 8716251 — drug product
US 8221786*PED — drug product
US 6515117*PED — drug product
US 8501698*PED — drug product
US 8361972*PED — drug product
US 7851502*PED — drug product
US 7919598*PED — drug product
US 8361972*PED — drug product
US 8501698*PED — drug product
US 7851502*PED — drug product
US 6515117*PED — drug product
US 7919598*PED — drug product
US 8221786*PED — drug product
US 8716251*PED — drug product
US 8716251*PED — drug product
US 8685934*PED — drug product
US 8685934*PED — drug product
US 8329648*PED — drug product
US 8329648*PED — drug product
US 8721615*PED — drug product
US 8721615*PED — drug product
US 8906851*PED — drug product
US 8906851*PED — drug product
US 12472194*PED — drug product
US 11826376*PED — drug product
US 11903955*PED — drug product
US 10973836*PED — drug product
US 12409186*PED — drug product
US 12213988*PED — drug product
Exclusivity M-298
Exclusivity NPP
Exclusivity M-298
Exclusivity NPP
Exclusivity PED
Exclusivity PED
Exclusivity PED
Exclusivity PED
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (64)
PatentTypeUse codeExpires
US 8685934 ↗ Method of use U-1522 May 26, 2030
US 8906851 ↗ Method of use U-2139 Aug 18, 2026
US 8329648 ↗ Method of use U-2213 Aug 18, 2026
US 8329648 ↗ Method of use U-2139 Aug 18, 2026
US 8329648 ↗ Method of use U-2139 Aug 18, 2026
US 6515117 ↗ Drug substance U-493 Oct 4, 2025
US 8361972 ↗ Method of use U-2139 Mar 21, 2028
US 8361972 ↗ Method of use U-2139 Mar 21, 2028
US 6515117 ↗ Drug substance U-2139 Oct 4, 2025
US 8501698 ↗ Method of use U-493 Jun 20, 2027
US 8501698 ↗ Method of use U-493 Jun 20, 2027
US 8685934 ↗ Method of use U-1522 May 26, 2030
US 8361972 ↗ Method of use U-493 Mar 21, 2028
US 8329648 ↗ Method of use U-2212 Aug 18, 2026
US 8361972 ↗ Method of use U-493 Mar 21, 2028
US 8329648 ↗ Method of use U-2212 Aug 18, 2026
US 8906851 ↗ Method of use U-2139 Aug 18, 2026
US 10973836 ↗ Method of use U-3127 Mar 9, 2040
US 12213988 ↗ Method of use U-4140 Apr 1, 2041
US 12409186 ↗ Method of use U-4140 Apr 1, 2041
US 12472194 ↗ Method of use U-4346 Jul 18, 2039
US 8329648 ↗ Method of use U-2213 Aug 18, 2026
US 11826376 ↗ Method of use U-3766 Jul 18, 2039
US 11903955 ↗ Method of use U-3825 Mar 9, 2040
US 6515117 ↗ Drug substance U-2139 Oct 4, 2025
US 6515117 ↗ Drug substance U-493 Oct 4, 2025
US 7851502 ↗ Drug product — Aug 19, 2028
US 8721615 ↗ delist req. Drug product — Jan 18, 2030
US 8221786 ↗ Drug product — Mar 21, 2028
US 7919598 ↗ Drug substance — Dec 16, 2029
US 8221786 ↗ Drug product — Mar 21, 2028
US 8716251 ↗ Drug product — Mar 21, 2028
US 7851502 ↗ Drug product — Aug 19, 2028
US 8721615 ↗ delist req. Drug product — Jan 18, 2030
US 7919598 ↗ Drug substance — Dec 16, 2029
US 8716251 ↗ Drug product — Mar 21, 2028
US 8221786*PED ↗ Drug product — Sep 21, 2028
US 6515117*PED ↗ Drug product — Apr 4, 2026
US 8501698*PED ↗ Drug product — Dec 20, 2027
US 8361972*PED ↗ Drug product — Sep 21, 2028
US 7851502*PED ↗ Drug product — Feb 19, 2029
US 7919598*PED ↗ Drug product — Jun 16, 2030
US 8361972*PED ↗ Drug product — Sep 21, 2028
US 8501698*PED ↗ Drug product — Dec 20, 2027
US 7851502*PED ↗ Drug product — Feb 19, 2029
US 6515117*PED ↗ Drug product — Apr 4, 2026
US 7919598*PED ↗ Drug product — Jun 16, 2030
US 8221786*PED ↗ Drug product — Sep 21, 2028
US 8716251*PED ↗ Drug product — Sep 21, 2028
US 8716251*PED ↗ Drug product — Sep 21, 2028
US 8685934*PED ↗ Drug product — Nov 26, 2030
US 8685934*PED ↗ Drug product — Nov 26, 2030
US 8329648*PED ↗ Drug product — Feb 18, 2027
US 8329648*PED ↗ Drug product — Feb 18, 2027
US 8721615*PED ↗ Drug product — Jul 18, 2030
US 8721615*PED ↗ Drug product — Jul 18, 2030
US 8906851*PED ↗ Drug product — Feb 18, 2027
US 8906851*PED ↗ Drug product — Feb 18, 2027
US 12472194*PED ↗ Drug product — Jan 18, 2040
US 11826376*PED ↗ Drug product — Jan 18, 2040
US 11903955*PED ↗ Drug product — Sep 9, 2040
US 10973836*PED ↗ Drug product — Sep 9, 2040
US 12409186*PED ↗ Drug product — Oct 1, 2041
US 12213988*PED ↗ Drug product — Oct 1, 2041
FDA exclusivity
CodeWhat it grantsExpires
M-298New indication / labeling change (3-year)May 8, 2026
NPPNew Patient PopulationJun 12, 2027
M-298New indication / labeling change (3-year)May 8, 2026
NPPNew Patient PopulationJun 12, 2027
PEDPediatric Exclusivity (+6 months)Nov 8, 2026
PEDPediatric Exclusivity (+6 months)Nov 8, 2026
PEDPediatric Exclusivity (+6 months)Dec 12, 2027
PEDPediatric Exclusivity (+6 months)Dec 12, 2027
Common questions
Is there a generic version of FARXIGA 5 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for FARXIGA 5 MG TABLET. 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets00310-6205-30 190,746 Rx · $147,919,093
90 tablets00310-6205-90 5,309 Rx · $5,717,660
7 tablets this page00310-6205-95 No Medicaid data
Drug total (last 4 qtrs): 196,055 Rx · 7,970,443 units · $153,636,752 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Farxiga — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Farxiga. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$385.3M
Claims incl. refills
1.2M
Beneficiaries
755.1K
Spend / beneficiary
$510.24
Spend / claim
$328.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00310-6205-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30) $12.08 / ea $362.27 2015-02-02 Active
00310-6205-95 You're viewing this 1 BLISTER PACK in 1 CARTON (0310-6205-95) / 7 TABLET, FILM COATED in 1 BLISTER PACK — — 2015-02-02 Active
00310-6205-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-90) $12.08 / ea $1,086.80 2024-03-18 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00310-6205-95?
NDC 00310-6205-95 is a 7-count package — 1 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack.
What is the difference between NDC 00310-6205-95 and NDC 00310-6205-30?
Both are FARXIGA DAPAGLIFLOZIN 5 mg Tablet, Film Coated — the drug itself is identical. NDC 00310-6205-95 is the 7-count package, while NDC 00310-6205-30 is the 30 tablets package.
What NDC number is used to bill for this package of FARXIGA DAPAGLIFLOZIN 5 mg Tablet, Film Coated?
Bill NDC 00310-6205-95 — the 11-digit billing format is 00310620595. 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.

🧭 About this NDC listing & data coverage

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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 FDA registers it as 0310-6205-95, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00310-6205-95, written without dashes as 00310620595. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00310-6205-95, the first segment (00310) is the labeler code FDA assigned to AstraZeneca Pharmaceuticals LP; the middle segment (6205) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (95) identifies this exact package size and type. Together they name one specific package of one specific product.
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 AstraZeneca Pharmaceuticals LP. 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 30 tablets (00310-6205-30), 90 tablets (00310-6205-90). 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?
AstraZeneca Pharmaceuticals LP 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.

📄 Full prescribing information FDA SPL

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

1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . • FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. • FARXIGA is 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.

FARXIGA is not expected to be effective in these populations. FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. (1) • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.

(1) • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. (1) • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. (1) Limitations of use: • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

(1) • Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. (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.

FARXIGA is not expected to be effective in these populations. (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Assess renal function prior to initiation and then as clinically indicated. Assess volume status and correct volume depletion before initiating. (2.1) • To improve glycemic control, the recommended starting dosage is 5 mg orally once daily.

Dosage can be increased to 10 mg orally once daily for additional glycemic control. (2.2) • For all other indications, the recommended dosage is 10 mg orally once daily. ( 2.3 ) • See full prescribing information for dosage recommendations in patients with renal impairment.

( 2.2 , 2.3 ) • Withhold FARXIGA for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.4 )

2.1Testing Prior to Initiation of FARXIGA • Assess renal function prior to initiation of FARXIGA and then as clinically indicated [see Warnings and Precautions (5.2) ]. • Assess volume status. In patients with volume depletion, correct this condition before initiating FARXIGA [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ] .

2.2Recommended Dosage for Glycemic Control in Adults and Pediatric Patients Aged 10 Years and Older with Type 2 Diabetes Mellitus In adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, the recommended starting dosage of FARXIGA is 5 mg orally once daily to improve glycemic control. For additional glycemic control, the dosage can be increased to 10 mg orally once daily. For Adult and Pediatric Patients with Type 2 Diabetes Mellitus and Renal Impairment: • The recommended dosage for FARXIGA in patients with an 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. • FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 .

FARXIGA is likely to be ineffective to improve glycemic control in this setting based upon its mechanism of action.

2.3Recommended Dosage for Other Indications in Adults The recommended dosage of FARXIGA is 10 mg orally once daily in adults for the following indications: • To reduce the risk of sustained eGFR decline, end-stage kidney disease (ESKD), CV death, and hospitalization for heart failure (hHF) in patients with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hHF, and urgent heart failure visit in patients with heart failure. • To reduce the risk of hHF in patients with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.

For Adults with Renal Impairment Receiving FARXIGA for Indications Other than Glycemic Control: • The recommended dosage of FARXIGA in patients with an eGFR greater than or equal to 25 mL/min/1.73 m 2 is the same as the recommended dosage in patients with normal renal function. • Initiation with FARXIGA is not recommended in patients with an eGFR less than 25 mL/min/1.73 m 2 . • If the eGFR falls below 25 mL/min/1.73 m 2 while receiving treatment with FARXIGA, patients may continue FARXIGA 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF.

2.4Temporary Interruption for Surgery Withhold FARXIGA for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume FARXIGA when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ].

2.5Recommendations Regarding Missed Dose • If a dose is missed, instruct patients to take the dose as soon as possible. • Advise patients not to double up the next dose.

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: • 5 mg, yellow, biconvex, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. • 10 mg, yellow, biconvex, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. • Tablets: 5 mg and 10 mg ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS FARXIGA is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with FARXIGA [see Adverse Reactions (6.1) ] . • History of serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue FARXIGA if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.

(5.1) • Volume depletion: Before initiating FARXIGA, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. ( 5.2 ) • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections: Monitor patients for signs and symptoms of genitourinary infections and treat promptly, if indicated.

Immediately evaluate patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, for necrotizing fasciitis and if suspected, discontinue FARXIGA, and promptly institute appropriate medical and/or surgical intervention (5.3) • Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with FARXIGA. (5.4)

5.1Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, FARXIGA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate. In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium-glucose cotransporter 2 (SGLT2) inhibitors compared to patients who received placebo. FARXIGA is not indicated for glycemic control in patients with type 1 diabetes mellitus.

Type 2 diabetes mellitus and pancreatic disorders (e.g., history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes mellitus using SGLT2 inhibitors, including FARXIGA. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.

Signs and symptoms are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Blood glucose levels at presentation may be below those typically expected for diabetic ketoacidosis (e.g., less than 250 mg/dL). Ketoacidosis and glucosuria may persist longer than typically expected.

Urinary glucose excretion persists for 3 days after discontinuing FARXIGA [see Clinical Pharmacology (12.2) ] ; however, there have been postmarketing reports of ketoacidosis and/or glucosuria lasting greater than 6 days and some up to 2 weeks after discontinuation of SGLT2 inhibitors. Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis if indicated by the clinical situation. Assess for ketoacidosis regardless of presenting blood glucose levels in patients who present with signs and symptoms consistent with severe metabolic acidosis.

If ketoacidosis is suspected, discontinue FARXIGA, promptly evaluate, and treat ketoacidosis, if confirmed. Monitor patients for resolution of ketoacidosis before restarting FARXIGA. Withhold FARXIGA, if possible, in temporary clinical situations that could predispose patients to ketoacidosis.

Resume FARXIGA when the patient is clinically stable and has resumed oral intake [see Dosage and Administration (2.4) ] . Educate all p…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] • Volume Depletion [see Warnings and Precautions (5.2) ] • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.3) ] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.4) ] • Most common adverse reactions (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.

( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 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. FARXIGA has been evaluated in clinical trials in adult and pediatric patients aged 10 years and older with type 2 diabetes mellitus, in adult patients with heart failure, and in adult patients with chronic kidney disease.

The overall safety profile of FARXIGA was consistent across the studied indications. No new adverse reactions were identified in the DAPA-HF and DELIVER heart failure trials, or in the DAPA-CKD trial in patients with chronic kidney disease. Severe hypoglycemia and diabetic ketoacidosis (DKA) were observed only in patients with diabetes mellitus.

Clinical Trials for Glycemic Control in Adult Patients with Type 2 Diabetes Mellitus Pool of 12 Placebo-Controlled Adult Trials for FARXIGA 5 and 10 mg for Glycemic Control The data in Table 1 is derived from 12 glycemic control placebo-controlled trials in adult patients with type 2 diabetes mellitus ranging from 12 to 24 weeks. In 4 trials FARXIGA was used as monotherapy, and in 8 trials FARXIGA was used as add-on to background antidiabetic therapy or as combination therapy with metformin [see Clinical Studies (14.1) ] .

These data reflect exposure of 2338 adult patients to FARXIGA with a mean exposure duration of 21 weeks. Patients received placebo (N=1393), FARXIGA 5 mg (N=1145), or FARXIGA 10 mg (N=1193) once daily. The mean age of the population was 55 years and 2% were older than 75 years of age.

Fifty percent (50%) of the population were male; 81% were White, 14% were Asian, and 3% were Black or African American. At baseline, the population had diabetes for an average of 6 years, had a mean hemoglobin A1c (HbA1c) of 8.3%, and 21% had established microvascular complications of diabetes. Baseline renal function was normal or mildly impaired in 92% of patients and moderately impaired in 8% of patients (mean eGFR 86 mL/min/1.73 m 2 ).

Table 1 shows common adverse reactions in adults associated with the use of FARXIGA. These adverse reactions were not present at baseline, occurred more commonly on FARXIGA than on placebo, and occurred in at least 2% of patients treated with either FARXIGA 5 mg or FARXIGA 10 mg. Table 1: Adverse Reactions in Placebo-Controlled Trials of Glycemic Control Reported in ≥2% of Adults Treated with FARXIGA Adverse Reaction % of Patients Pool of 12 Placebo-Controlled Trials Placebo N=1393 FARXIGA 5 mg N=1145 FARXIGA 10 mg N=1193 Female genital mycotic infections Genital mycotic infections include the following adverse reactions, listed in order of frequency reported for females: vulvovaginal mycotic infection, vaginal infection, vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and vaginitis bacterial.

(N for females: Placebo=677, FARXIGA 5 mg=581, FARXIGA 10 mg=…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Table 4: Clinically Relevant Interactions with FARXIGA Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when FARXIGA is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see Warnings and Precautions (5.4) ]. Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of 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 FARXIGA 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. • See full prescribing information for information on drug interactions and interference of FARXIGA with laboratory tests. (7)

Drug Interactions In Vitro Assessment of Drug Interactions In in vitro studies, dapagliflozin and dapagliflozin 3-O-glucuronide neither inhibited CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4. Dapagliflozin is a weak substrate of the P-glycoprotein (P-gp) active transporter, and dapagliflozin 3-O-glucuronide is a substrate for the OAT3 active transporter. Dapagliflozin or dapagliflozin 3-O-glucuronide did not meaningfully inhibit P-gp, OCT2, OAT1, or OAT3 active transporters.

Overall, dapagliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are P-gp, OCT2, OAT1, or OAT3 substrates. Effects of Other Drugs on Dapagliflozin Table 5 shows the effect of coadministered drugs on the pharmacokinetics of dapagliflozin in adults. No dose adjustments are recommended for dapagliflozin.

Table 5: Effects of Coadministered Drugs on Dapagliflozin Systemic Exposure Coadministered Drug (Dose Regimen) Single dose unless otherwise noted. Dapagliflozin (Dose Regimen) Effect on Dapagliflozin Exposure [% Change (90% CI)] C max AUC AUC = AUC(INF) for drugs given as single dose and AUC = AUC(TAU) for drugs given in multiple doses. No dosing adjustments required for the following: Oral Antidiabetic Agents Metformin (1000 mg) 20 mg ↔ ↔ Pioglitazone (45 mg) 50 mg ↔ ↔ Sitagliptin (100 mg) 20 mg ↔ ↔ Glimepiride (4 mg) 20 mg ↔ ↔ Voglibose (0.2 mg three times daily) 10 mg ↔ ↔ Other Medications Hydrochlorothiazide (25 mg) 50 mg ↔ ↔ Bumetanide (1 mg) 10 mg once daily for 7 days ↔ ↔ Valsartan (320 mg) 20 mg ↓12% [↓3%, ↓20%] ↔ Simvastatin (40 mg) 20 mg ↔ ↔ Anti-infective Agent Rifampin (600 mg once daily for 6 days) 10 mg ↓7% [↓22%, ↑11%] ↓22% [↓27%, ↓17%] Nonsteroidal Anti-inflammatory Agent Mefenamic Acid (loading dose of 500 mg followed by 14 doses of 250 mg every 6 hours) 10 mg ↑13% [↑3%, ↑24%] ↑51% [↑44%, ↑58%] ↔ = no change (geometric mean ratio of test: reference within 0.80 to 1.25); ↓ or ↑ = parameter was lower or higher, respectively, with coadministration compared to dapagliflozin administered alone (geometric mean ratio of test: reference was lower than 0.80 or higher than 1.25).

Effects of Dapagliflozin on Other Drugs Table 6 shows the effect of dapagliflozin on other coadministered drugs in adults. Dapagliflozin did not meaningfully affect the pharmacokinetics of the coadministered drugs. Table 6: Effects of Dapagliflozin on the Systemic Exposures of Coadministered Drugs Coadministered Drug (Dose Regimen) Single dose unless otherwise noted.

Dapagliflozin (Dose Regimen) Effect on Coadministered Drug Expo…

👥 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) • Geriatrics: Higher incidence of adverse reactions related to hypotension. ( 8.5 ) • Renal Impairment: Higher incidence of adverse reactions related to volume depletion. ( 8.6 )

8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure 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 Animal Data 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. 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 at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on AUC). Dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure 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 Animal Data 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. 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 at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on AUC). Dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on AUC), which were associated with maternal toxicity.

No developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on AUC).

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of FARXIGA as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients aged 10 years and older. Use of FARXIGA for this indication is supported by a 26-week placebo-controlled trial with a 26-week extension in 157 pediatric patients aged 10 to 17 years with type 2 diabetes mellitus, pediatric pharmacokinetic data, and trials in adults with type 2 diabetes mellitus [see Clinical Pharmacology (12.3) and Clinical Studies (14.1 , 14.2) ] .

The safety profile observed in the placebo-controlled trial in pediatric patients with type 2 diabetes mellitus was similar to that observed in adults [see Adverse Reactions (6.1) ] . The safety and effectiveness of FARXIGA for glycemic control in type 2 diabetes mellitus have not been established in pediatric patients less than 10 years of age. The safety and effectiveness of FARXIGA have not been established in pediatric patients to reduce the risk of [see Indications and Usage (1) ] : • sustained eGFR decline, end-stage kidney disease, CV death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • CV 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 CV disease or multiple CV risk factors.

🧓 Geriatric Use 193 words ▾

8.5Geriatric Use No FARXIGA dosage change is recommended based on age. A total of 1424 (24%) of the 5936 FARXIGA-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 FARXIGA in improving glycemic control in type 2 diabetes mellitus. 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 FARXIGA for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . In the DAPA-CKD, DAPA-HF and DELIVER trials, safety and efficacy were similar for patients aged 65 years and younger and those older than 65. In the DAPA-HF study, 2714 (57%) out of 4744 patients with HFrEF were older than 65 years.

In the DELIVER study, 4759 (76%) out of 6263 patients with heart failure (LVEF >40%) were older than 65 years. In the DAPA-CKD study, 1818 (42%) out of 4304 patients with CKD were older than 65 years.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE There were no reports of overdose during the clinical development program for FARXIGA. 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. It is also reasonable to employ supportive measures as dictated by the patient’s clinical status. The removal of dapagliflozin by hemodialysis has not been studied.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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.

12.2Pharmacodynamics General 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 at Week 12. 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) Figure 1 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.

12.3Pharmacokinetics Absorption 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 are not considered to be clinically meaningful and dapagliflozin can be administered with or without food Distribution Dapagliflozin is approximately 91% protein bound. Protein binding is not altered in patients with renal or hepatic impairment.

Metabolism The metabolism of dapagliflozin is primarily mediated by UGT1A9; CYP-mediated metabolism is a minor clearance pathway in humans. Dapagliflozin is extensively metabolized, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite. Dapagliflozin 3-O-glucuronide accounted for 61% of a 50 mg [ 14 C]-dapagliflozin dose and is the predominant drug-related component in human plasma.

Elimination Dapagliflozin and related metabolites are primarily eliminated via the renal pathway. Following a single 50 mg dose of [ 14 C]-dapagliflozin, 75% and 21% total radioactivity is excreted in urine and feces, respectively. In urine, less than 2% of the dose is excreted as parent drug.

In feces, approximately 15% of the dose is excreted as parent drug. The mean plasma terminal half-life (t ½ ) for dapagliflozin is approximately 12.9 hours following a single oral dose of FARXIGA 10 mg. Specific Populations Pediatric Patients T…

🧬 Mechanism of Action 103 words ▾

12.1Mechanism of Action 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.

📦 How Supplied / Storage and Handling 136 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied FARXIGA (dapagliflozin) tablets have markings on both sides and are available in the strengths and packages listed in Table 18. Table 18: FARXIGA Tablet Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg yellow, biconvex, round “5” engraved on one side and “1427” engraved on the other side Bottles of 30 0310-6205-30 Bottles of 90 0310-6205-90 10 mg yellow, biconvex, diamond-shaped “10” engraved on one side and “1428” engraved on the other side Bottles of 30 0310-6210-30 Bottles of 90 0310-6210-90 Hospital Unit Dose Blister Pack: Carton containing 30 tablets (3 blister cards x 10 tablets per card) 0310-6210-39 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 123 words ▾

11 DESCRIPTION Dapagliflozin, an inhibitor of SGLT2, is described chemically as D-glucitol, 1,5-anhydro-1- C -[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S )-, compounded with (2 S )-1,2-propanediol, hydrate (1:1:1). The empirical formula is C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the molecular weight is 502.98. The structural formula is: FARXIGA is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. Dapagliflozin Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, inform them that using FARXIGA can increase their risk of life-threatening diabetic ketoacidosis. For all other patients, inform them that FARXIGA 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 FARXIGA and seek medical attention immediately [see Warnings and Precautions (5.1) ] . Volume Depletion Inform patients that symptomatic hypotension may occur with FARXIGA and advise them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions (5.2) ] . Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections Counsel patients that genitourinary infections may occur when taking FARXIGA and may become serious. Educate patients on the symptoms and advise them to seek medical advice if symptoms occur. Specifically, advise patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4°F or malaise [see Warnings and Precautions (5.3) ] .

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Inform patients that the incidence of hypoglycemia may increase when FARXIGA 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 (5.4) ] . Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions (e.g., urticaria, anaphylactic reactions, and angioedema) have been reported with FARXIGA.

Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema, and to take no more of the drug until they have consulted prescribing physicians. Pregnancy Advise pregnant patients of the potential risk to a fetus with treatment with FARXIGA. Instruct patients to immediately inform their healthcare provider if pregnant or planning to become pregnant [see Use in Specific Populations (8.1) ] .

Lactation Advise patients that use of FARXIGA is not recommended while breastfeeding [see Use in Specific Populations (8.2) ]. Laboratory Tests Due to its mechanism of action, patients taking FARXIGA will test positive for glucose in their urine. Missed Dose Instruct patients to take FARXIGA only as prescribed.

If a dose is missed, it should be taken as soon as possible. Advise patients not to double their next dose [see Dosage and Administration (2.5) ] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 FARXIGA ® is a registered trademark of the AstraZeneca group of companies.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE FARXIGA ® [FAR-SEE-GUH] (dapagliflozin) tablets, for oral use What is the most important information I should know about FARXIGA? FARXIGA can cause serious side effects, including: • Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. FARXIGA 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. 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 FARXIGA 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 ∘ tiredness ∘ vomiting ∘ trouble breathing ∘ stomach area (abdominal) pain ∘ ketones in your urine or blood • Dehydration. FARXIGA can cause some people to become dehydrated (the loss of body water and salt).

Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking FARXIGA . You may be at a higher risk of dehydration if you: ∘ take medicines to lower your blood pressure, including water pills (diuretics) ∘ are on a low salt diet ∘ have kidney problems ∘ are 65 years of age or older Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis.

Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long. • Genital and urinary tract infections. FARXIGA can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum).

This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: ∘ pain or tenderness ∘ swelling ∘ redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: ∘ Urinary tract infection: ▪ burning feeling when you urinate ▪ need to urinate often or right away ▪ pain in the lower part of your stomach (pelvis) ▪ blood in your urine You may also have a fever, back pain, nausea, or vomiting. ∘ Vaginal yeast infection: ▪ vaginal odor ▪ white or yellowish vaginal discharge (may be lumpy or look like cottage cheese) ▪ vaginal itching ∘ Yeast infection of the skin around the penis (balanitis or balanoposthitis): If you are uncircumcised, swelling may make it difficult to pull back the skin around the tip of your penis.

Other symptoms include: ▪ redness, itching, or swelling of the penis ▪ rash on the penis ▪ bad smelling discharge from the penis ▪ pain in the skin around the penis Talk to your healthcare provider ab…

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