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JARDIANCE Empagliflozin 10 mg Tablet, Film Coated, 30-count — NDC 50090-4492-01 package photo

JARDIANCE Empagliflozin 10 mg Tablet, Film Coated, 30-count

by A-S Medication Solutions · 30 TABLET, FILM COATED in 1 BOTTLE (50090-4492-1)
NDC 50090-4492-01
🏷️ FDA NDC (as labeled) 50090-4492-1 billing pads the package segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $6.79/unit — full pricing hub ↓
Also comes in: 90 tablets 50090-4492-00
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 50090-4492-1
Product NDC 50090-4492
11-digit billing NDC 50090449201
NCPDP billing unit EA — each (per item)
RxCUI 1545658, 1545664
UNII HDC1R2M35U
Application # NDA204629
SPL Set ID 942a82a4-cbbd-4e44-9965-8d03f767912b
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 2014-08-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance EMPAGLIFLOZIN
GPI-14 27700050000310
GPI class Jardiance
GCN Seq No 072488
GCN 36716
HICL code 041217
Ingredient (HICL) Empagliflozin
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 JARDIANCE 10 MG TABLET
FDB brand name Jardiance
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 50090-4492-1 — a 5-4-1 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 package segment → 50090-4492-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sodium-Glucose Cotransporter 2 Inhibitor class.

Pharmacologic class Sodium-Glucose Cotransporter 2 Inhibitor
Drug family (ATC) Sodium-glucose co-transporter 2 (SGLT2) inhibitors
How it works Sodium-Glucose Transporter 2 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderBOEHRINGER INGELHEIM PHARMACEUTICALS INC
FDA applicationNDA204629 (NDA)
Labeler code50090
First marketedAug 2014
Product typeHuman Prescription Drug
Portfolio2,774 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 JARDIANCE 10 MG TABLET Ingredient Empagliflozin
📖 What it is MedlinePlus · NLM

Empagliflozin 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). reduce the risk of stroke, heart attack, or death in certain people who have type 2 diabetes. reduce the risk of being hospitalized for heart failure and death in adults with heart failure. reduce the risk of worsening of kidney disease, being hospitalized for heart failure, and death in certain adults with kidney disease. Empagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Jardiance does much more than just lower blood sugar. Yes, it's approved to help control blood sugar in type 2 diabetes — but it's also proven to reduce serious risks in heart fail...
  • What exactly does Jardiance do — is it just for blood sugar?
  • That's completely expected. Jardiance works by causing your kidneys to release excess glucose through your urine, and extra fluid follows along with it. This is actually part of ho...
  • Why am I urinating more often since starting this medication?
📖 Read our full Empagliflozin guide →
1
Nutrient depletion considerations

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

🧪 Full Empagliflozin 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
ShapeRound
ImprintS;10
Size9 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $6.79 $203.82 / 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Jardiance 10 mg 00597-0152-07 Boehringer 7 tablets — — FDA listed —
Jardiance 10 mgthis 50090-4492-01 A-S 30 tablets — — FDA listed —
Jardiance 10 mg 50090-6452-00 A-S 90 tablets — — FDA listed —
Jardiance 10 mg 55154-0411-08 Cardinal 720 tablets — — FDA listed —
Jardiance 10 mg 71610-0900-09 Aphena 9000 tablets — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
Aug 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 1, 2014 RLD RS ⏳ ~8.2 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 9949998 — method of use (U-2290)
US 9949998 — method of use (U-2290)
US 9949997 — method of use (U-2292)
US 10258637 — method of use (U-2290)
US 8551957 — method of use (U-1651)
US 10258637 — method of use (U-2290)
US 9949997 — method of use (U-2292)
US 9949997 — method of use (U-3325)
US 9949997 — method of use (U-3199)
US 12115179 — method of use (U-4023)
US 12115179 — method of use (U-4023)
US 11090323 — method of use (U-3191)
US 11090323 — method of use (U-3191)
US 12433906 — method of use (U-4304)
US 12433906 — method of use (U-4304)
US 12263153 — method of use (U-4171)
US 12263153 — method of use (U-4171)
US 12433906 — method of use (U-4293)
US 12433906 — method of use (U-4293)
US 12433906 — method of use (U-4294)
US 12433906 — method of use (U-4294)
US 12433906 — method of use (U-4295)
US 12433906 — method of use (U-4295)
US 12433906 — method of use (U-4296)
US 12433906 — method of use (U-4296)
US 12427162 — method of use (U-4287)
US 12427162 — method of use (U-4287)
US 12527810 — method of use (U-4403)
US 12527810 — method of use (U-4403)
US 8551957 — method of use (U-1651)
US 11666590 — method of use (U-3691)
US 11833166 — method of use (U-3776)
US 11833166 — method of use (U-3777)
US 11833166 — method of use (U-3777)
US 11833166 — method of use (U-3776)
US 11813275 — method of use (U-3759)
US 11813275 — method of use (U-3760)
US 7579449 — drug substance
US 7713938 — drug substance
US 7713938 — drug substance
US 7579449 — drug substance
US 7579449*PED — drug product
US 7713938*PED — drug product
US 7713938*PED — drug product
US 7579449*PED — drug product
US 9949998*PED — drug product
US 9949997*PED — drug product
US 9949997*PED — drug product
US 9949998*PED — drug product
US 8551957*PED — drug product
US 8551957*PED — drug product
US 10258637*PED — drug product
US 10258637*PED — drug product
US 11813275*PED — drug product
US 11833166*PED — drug product
US 11833166*PED — drug product
US 12115179*PED — drug product
US 12115179*PED — drug product
US 11090323*PED — drug product
US 11090323*PED — drug product
US 12433906*PED — drug product
US 12433906*PED — drug product
US 12527810*PED — drug product
US 12527810*PED — drug product
Exclusivity I-922
Exclusivity NPP
Exclusivity NPP
Exclusivity PED
Exclusivity PED
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032 2034
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 9949998 ↗ Method of use U-2290 Jun 11, 2034
US 9949998 ↗ Method of use U-2290 Jun 11, 2034
US 9949997 ↗ Method of use U-2292 May 17, 2034
US 10258637 ↗ Method of use U-2290 Apr 3, 2034
US 8551957 ↗ Method of use U-1651 Oct 14, 2029
US 10258637 ↗ Method of use U-2290 Apr 3, 2034
US 9949997 ↗ Method of use U-2292 May 17, 2034
US 9949997 ↗ Method of use U-3325 May 17, 2034
US 9949997 ↗ Method of use U-3199 May 17, 2034
US 12115179 ↗ Method of use U-4023 Feb 11, 2030
US 12115179 ↗ Method of use U-4023 Feb 11, 2030
US 11090323 ↗ Method of use U-3191 Apr 3, 2034
US 11090323 ↗ Method of use U-3191 Apr 3, 2034
US 12433906 ↗ Method of use U-4304 Apr 3, 2034
US 12433906 ↗ Method of use U-4304 Apr 3, 2034
US 12263153 ↗ Method of use U-4171 Apr 3, 2034
US 12263153 ↗ Method of use U-4171 Apr 3, 2034
US 12433906 ↗ Method of use U-4293 Apr 3, 2034
US 12433906 ↗ Method of use U-4293 Apr 3, 2034
US 12433906 ↗ Method of use U-4294 Apr 3, 2034
US 12433906 ↗ Method of use U-4294 Apr 3, 2034
US 12433906 ↗ Method of use U-4295 Apr 3, 2034
US 12433906 ↗ Method of use U-4295 Apr 3, 2034
US 12433906 ↗ Method of use U-4296 Apr 3, 2034
US 12433906 ↗ Method of use U-4296 Apr 3, 2034
US 12427162 ↗ Method of use U-4287 Apr 3, 2034
US 12427162 ↗ Method of use U-4287 Apr 3, 2034
US 12527810 ↗ Method of use U-4403 Apr 22, 2033
US 12527810 ↗ Method of use U-4403 Apr 22, 2033
US 8551957 ↗ Method of use U-1651 Oct 14, 2029
US 11666590 ↗ Method of use U-3691 Apr 3, 2034
US 11833166 ↗ Method of use U-3776 Apr 3, 2034
US 11833166 ↗ Method of use U-3777 Apr 3, 2034
US 11833166 ↗ Method of use U-3777 Apr 3, 2034
US 11833166 ↗ Method of use U-3776 Apr 3, 2034
US 11813275 ↗ Method of use U-3759 Apr 3, 2034
US 11813275 ↗ Method of use U-3760 Apr 3, 2034
US 7579449 ↗ Drug substance — Aug 1, 2028
US 7713938 ↗ Drug substance — Apr 15, 2027
US 7713938 ↗ Drug substance — Apr 15, 2027
US 7579449 ↗ Drug substance — Aug 1, 2028
US 7579449*PED ↗ Drug product — Feb 1, 2029
US 7713938*PED ↗ Drug product — Oct 15, 2027
US 7713938*PED ↗ Drug product — Oct 15, 2027
US 7579449*PED ↗ Drug product — Feb 1, 2029
US 9949998*PED ↗ Drug product — Dec 11, 2034
US 9949997*PED ↗ Drug product — Nov 17, 2034
US 9949997*PED ↗ Drug product — Nov 17, 2034
US 9949998*PED ↗ Drug product — Dec 11, 2034
US 8551957*PED ↗ Drug product — Apr 14, 2030
US 8551957*PED ↗ Drug product — Apr 14, 2030
US 10258637*PED ↗ Drug product — Oct 3, 2034
US 10258637*PED ↗ Drug product — Oct 3, 2034
US 11813275*PED ↗ Drug product — Oct 3, 2034
US 11833166*PED ↗ Drug product — Oct 3, 2034
US 11833166*PED ↗ Drug product — Oct 3, 2034
US 12115179*PED ↗ Drug product — Aug 11, 2030
US 12115179*PED ↗ Drug product — Aug 11, 2030
US 11090323*PED ↗ Drug product — Oct 3, 2034
US 11090323*PED ↗ Drug product — Oct 3, 2034
US 12433906*PED ↗ Drug product — Oct 3, 2034
US 12433906*PED ↗ Drug product — Oct 3, 2034
US 12527810*PED ↗ Drug product — Oct 22, 2033
US 12527810*PED ↗ Drug product — Oct 22, 2033
FDA exclusivity
CodeWhat it grantsExpires
I-922New indication (3-year)Sep 21, 2026
NPPNew Patient PopulationJun 20, 2026
NPPNew Patient PopulationJun 20, 2026
PEDPediatric Exclusivity (+6 months)Dec 20, 2026
PEDPediatric Exclusivity (+6 months)Dec 20, 2026
Common questions
Is there a generic version of JARDIANCE 10 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for JARDIANCE 10 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.

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

Medicare Part D (outpatient prescription) spending for Jardiance — 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 Jardiance. 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
$1.34B
Claims incl. refills
3.5M
Beneficiaries
2.3M
Spend / beneficiary
$593.45
Spend / claim
$386.83
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Empagliflozin — the ingredient across all brands.

Top reported reactions

Diabetic Ketoacidosis4,153
Nausea3,866
Blood Glucose Increased3,534
Diarrhoea3,424
Weight Decreased3,137
Fatigue3,061
Vomiting2,934

Age at onset

Neonate12
Infant18
Child10
Adolescent16
Adult10,409
Elderly12,630

Reporter sex

71,563 reports
Male · 53%
Female · 47%
Unknown · 0%

Serious outcomes

Hospitalization23,452
Life-threatening4,127
Death3,526
Disabling1,449
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,968 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50090-4492-00 90 TABLET, FILM COATED in 1 BOTTLE (50090-4492-0) 2019-08-29 Active
50090-4492-01 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (50090-4492-1) 2023-07-18 Active

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

Pack size FAQ

What quantity is in NDC 50090-4492-01?
NDC 50090-4492-01 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 50090-4492-01 and NDC 50090-4492-00?
Both are JARDIANCE Empagliflozin 10 mg Tablet, Film Coated — the drug itself is identical. NDC 50090-4492-01 is the 30-count package, while NDC 50090-4492-00 is the 90 tablets package.
What NDC number is used to bill for this package of JARDIANCE Empagliflozin 10 mg Tablet, Film Coated?
Bill NDC 50090-4492-01 — the 11-digit billing format is 50090449201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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?
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📄 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. 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. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

( 1 ) To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 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 in patients with type 1 diabetes mellitus.

It may increase the risk of diabetic ketoacidosis in these patients. ( 1 ) Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 ( 1 ) Limitations of Use JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1) ] .

JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m 2 . JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiating ( 2.1 ) Recommended dosage is 10 mg once daily in the morning, taken with or without food ( 2.2 ) For additional glycemic control, dosage may be increased to 25 mg in patients tolerating JARDIANCE ( 2.2 )

2.1Testing Prior to Initiation of JARDIANCE Assess renal function before initiating JARDIANCE and as clinically indicated [see Warnings and Precautions (5.2) ] . Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 [see Use in Specific Populations (8.6) ]. JARDIANCE is contraindicated in patients on dialysis [see Use in Specific Populations (8.6) ] .

Assess volume status in patients with volume depletion and correct this condition before initiating JARDIANCE [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5 , 8.6) ].

2.2Recommended Dosage Table 1 presents the recommended dosage of JARDIANCE in adult and pediatric patients aged 10 years and older. Table 1 Recommended Dosage of JARDIANCE Population Indication Recommended Dosage Adults Reduce the risk of cardiovascular death and hospitalization in patients with heart failure 10 mg orally once daily in the morning, taken with or without food. Data are insufficient to provide a dosage recommendation in patients who have: type 2 diabetes mellitus and established cardiovascular disease with an eGFR less than 30 mL/min/1.73 m 2 , or heart failure with an eGFR less than 20 mL/min/1.73 m 2 [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6) ] .

Reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus with established cardiovascular disease Glycemic control in type 2 diabetes mellitus 10 mg orally once daily in the morning, taken with or without food. For additional glycemic control, may increase to 25 mg orally once daily in patients tolerating 10 mg once daily. Pediatric patients aged 10 years and older Glycemic control in type 2 diabetes mellitus 10 mg orally once daily in the morning, taken with or without food.

For additional glycemic control, may increase to 25 mg orally once daily in patients tolerating 10 mg once daily.

2.3Recommendations Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Do not double up the next dose.

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS JARDIANCE tablets available as: 10 mg pale yellow, round, biconvex and bevel-edged, film-coated tablets debossed with "S 10" on one side and the Boehringer Ingelheim company symbol on the other side. 25 mg pale yellow, oval, biconvex, film-coated tablets debossed with "S 25" on one side and the Boehringer Ingelheim company symbol on the other side. Tablets: 10 mg, 25 mg ( 3 )

⛔ Contraindications 61 words ▾

4 CONTRAINDICATIONS JARDIANCE is contraindicated in patients: with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [see Warnings and Precautions (5.7) ] . on dialysis [see Use in Specific Populations (8.6) ] . Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE ( 4 ) Patients on dialysis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue JARDIANCE, evaluate and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis.

Patients on JARDIANCE may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. ( 5.1 ) Volume Depletion: Before initiating JARDIANCE, assess volume status and renal function in patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for signs and symptoms during therapy.

( 5.2 ) Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated ( 5.3 ) Hypoglycemia: Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher regardless of insulin use. Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating JARDIANCE.

( 5.4 ) 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.

( 5.5 ) Genital Mycotic Infections: Monitor and treat as appropriate ( 5.6 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., angioedema) have occurred with JARDIANCE. If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve. ( 5.7 )

5.1Ketoacidosis Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in clinical trials and postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including JARDIANCE. Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE. In placebo-controlled trials of patients with type 1 diabetes, the risk of ketoacidosis was increased in patients who received SGLT2 inhibitors compared to patients who received placebo.

JARDIANCE is not indicated for the treatment of patients with type 1 diabetes mellitus [see Indications and Usage (1) ] . Patients treated with JARDIANCE who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels, as ketoacidosis associated with JARDIANCE may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, JARDIANCE should be discontinued, patient should be evaluated, and prompt treatment should be instituted.

Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement. In many of the postmarketing reports, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized and institution of treatment was delayed because presenting blood glucose levels were below those typically expected for diabetic ketoacidosis (often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath.

In some but not all cases, factors predisposing to ketoacidosis such as insulin dose reduction, acute febrile illness, reduced caloric intake, surgery, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse were identified. Before initiating JARDIANCE, consider factors in the patient history that may predispose to ketoacidosis including pancreatic in…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Ketoacidosis [see Warnings and Precautions (5.1) ] Volume Depletion [see Warnings and Precautions (5.2) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.3) ] Hypoglycemia [see Warnings and Precautions (5.4) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.5) ] Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections and female genital mycotic infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 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 practice. JARDIANCE has been evaluated in clinical trials in adult and pediatric patients aged 10 to 17 years with type 2 diabetes mellitus and in adults with heart failure. The overall safety profile of JARDIANCE was generally consistent across the studied indications.

Clinical Trials in Adults with Type 2 Diabetes Mellitus The data in Table 2 are derived from a pool of four 24-week placebo-controlled trials and 18-week data from a placebo-controlled trial with insulin in adult patients with type 2 diabetes mellitus. JARDIANCE was used as monotherapy in one trial and as add-on therapy in four trials [see Clinical Studies (14) ] . These data reflect exposure of 1,976 adult patients to JARDIANCE with a mean exposure duration of approximately 23 weeks.

Patients received placebo (N=995), JARDIANCE 10 mg (N=999), or JARDIANCE 25 mg (N=977) once daily. The mean age of the population was 56 years and 3% were older than 75 years of age. More than half (55%) of the population was male; 46% were White, 50% were Asian, and 3% were Black or African American.

At baseline, 57% of the population had diabetes mellitus more than 5 years and had a mean hemoglobin A1c (HbA1c) of 8%. Established microvascular complications of diabetes mellitus at baseline included diabetic nephropathy (7%), retinopathy (8%), or neuropathy (16%). Baseline renal function was normal or mildly impaired in 91% of patients and moderately impaired in 9% of patients (mean eGFR 86.8 mL/min/1.73 m 2 ).

Table 2 shows adverse reactions (excluding hypoglycemia) that were not present at baseline, occurred more commonly in JARDIANCE-treated patients than on placebo and occurred in greater than or equal to 2% JARDIANCE-treated patients. Table 2 Adverse Reactions Reported in ≥2% of Adults with Type 2 Diabetes Mellitus Treated with JARDIANCE and Greater than Placebo in Pooled Placebo-Controlled Clinical Trials of JARDIANCE Monotherapy or Combination Therapy Adverse Reactions Placebo (%) N=995 JARDIANCE 10 mg (%) N=999 JARDIANCE 25 mg (%) N=977 a Predefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, cystitis b Female genital mycotic infections include the following adverse reactions: vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, genitourinary tract infection, vulvovaginitis, cervicitis, urogenital infection fungal, vaginitis bacterial.

Percentages calculated with the number of female subjects in each group as denominator: placebo (N=481), JARDIANCE 10 mg (N=443), JARDIANCE 25 mg (N=420). c Predefined adverse event grouping, including, but not limited to, polyuria, pollakiuria, and nocturia d Male genital mycotic infections include the following adverse reactions: balanoposthitis, balanitis, geni…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS See Table 4 for clinically relevant interactions with JARDIANCE. Table 4 Clinically Relevant Interactions with JARDIANCE Diuretics Clinical Impact Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion. Intervention Before initiating JARDIANCE, assess volume status and renal function.

In patients with volume depletion, correct this condition before initiating JARDIANCE. Monitor for signs and symptoms of volume depletion, and renal function after initiating therapy. Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin.

Intervention Coadministration of JARDIANCE with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin 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 JARDIANCE 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 JARDIANCE 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 ) Geriatric Patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function ( 8.5 , 8.6 ) Renal Impairment: Higher incidence of adverse reactions related to reduced renal function ( 8.6 )

8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] .

In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see Data ] . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, 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 Empagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 10, 30, and 100 mg/kg/day caused increased kidney weights and renal tubular and pelvic dilatation at 100 mg/kg/day, which approximates 13-times the maximum clinical dose of 25 mg, based on AUC. These findings were not observed after a 13-week, drug-free recovery period.

These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development. In embryo-fetal development studies in rats and rabbits, empagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Doses up to 300 mg/kg/day, which approximates 48-times (rats) and 128-times (rabbits) the maximum clinical dose of 25 mg (based on AUC), did not result in adverse developmental effects.

In rats, at higher doses of empagliflozin causing maternal toxicity, malformations of limb bones increased in fetuses at 700 mg/kg/day or 154-times the 25 mg maximum clinical dose. Empagliflozin crosses the placenta and reaches fetal tissues in rats. In the rabbit, higher doses of empagliflozin resulted in maternal and fetal toxicity at 700 mg/kg/day, or 139-times the 25 mg maximum clinical dose.

In pre- and postnatal development studies in pregnant rats, empagliflozin was administered from gestation day 6 through to lactation day 20 (weaning) at up to 100 mg/kg/day (approximately 16-times the 25 mg maximum clinical dose) without maternal toxicity. Reduced body weight was observed in the offspring at greater than or equal to 30 mg/kg/day (approximately 4-times the 25 mg maximum clinical dose).

8.2Lactation Risk Summary There is limited information regarding the presence of JARDIANCE in human milk, the effects of JARDIANCE on the breastfed infant or the effects on milk production. Empagliflozin is present in…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] .

In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately 13-times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible [see Data ] . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10.

The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, 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 Empagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 10, 30, and 100 mg/kg/day caused increased kidney weights and renal tubular and pelvic dilatation at 100 mg/kg/day, which approximates 13-times the maximum clinical dose of 25 mg, based on AUC. These findings were not observed after a 13-week, drug-free recovery period.

These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development. In embryo-fetal development studies in rats and rabbits, empagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Doses up to 300 mg/kg/day, which approximates 48-times (rats) and 128-times (rabbits) the maximum clinical dose of 25 mg (based on AUC), did not result in adverse developmental effects.

In rats, at higher doses of empagliflozin causing maternal toxicity, malformations of limb bones increased in fetuses at 700 mg/kg/day or 154-times the 25 mg maximum clinical dose. Empagliflozin crosses the placenta and reaches fetal tissues in rats. In the rabbit, higher doses of empagliflozin resulted in maternal and fetal toxicity at 700 mg/kg/day, or 139-times the 25 mg maximum clinical dose.

In pre- and postnatal development studies in pregnant rats, empagliflozin was administered from gestation day 6 through to lactation day 20 (weaning) at up to 100 mg/kg/day (approximately 16-times the 25 mg maximum clinical dose) without maternal toxicity. Reduced body weight was observed in the offspring at greater than or equal to 30 mg/kg/day (approximately 4-times the 25 mg maximum clinical dose).

🧒 Pediatric Use 165 words ▾

8.4Pediatric Use The safety and effectiveness of JARDIANCE 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 JARDIANCE for this indication is supported by evidence from a 26-week double-blind, placebo-controlled clinical trial, with a double-blind active treatment safety extension period of up to 52 weeks in 157 pediatric patients aged 10 to 17 years with type 2 diabetes mellitus and a pediatric pharmacokinetic study [see Clinical Pharmacology (12.3) and Clinical Studies (14.2) ] .

The safety profile of pediatric patients treated with JARDIANCE was similar to that observed in adults with type 2 diabetes mellitus, with the exception of hypoglycemia risk which was higher in pediatric patients treated with JARDIANCE regardless of concomitant insulin use [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ]. The safety and effectiveness of JARDIANCE have not been established in pediatric patients less than 10 years of age.

🧓 Geriatric Use 214 words ▾

8.5Geriatric Use In glycemic control trials in patients with type 2 diabetes mellitus, a total of 2,721 (32%) patients treated with JARDIANCE were 65 years of age and older, and 491 (6%) were 75 years of age and older. JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6) ] . The risk of volume depletion-related adverse reactions increased in patients who were 75 years of age and older to 2.1%, 2.3%, and 4.4% for placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg.

The risk of urinary tract infections increased in patients who were 75 years of age and older to 10.5%, 15.7%, and 15.1% in patients randomized to placebo, JARDIANCE 10 mg, and JARDIANCE 25 mg, respectively [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . In heart failure trials, EMPEROR-Reduced included 1,188 (64%) patients treated with JARDIANCE 65 years of age and older, and 503 (27%) patients 75 years of age and older. EMPEROR-Preserved included 2,402 (80%) patients treated with JARDIANCE 65 years of age and older, and 1,281 (43%) patients 75 years of age and older.

No overall differences in safety and effectiveness have been observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 35 words ▾

10 OVERDOSAGE In the event of an overdose with JARDIANCE, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.

This may influence several physiological functions such as lowering both pre- and afterload of the heart and downregulating sympathetic activity.

12.2Pharmacodynamics Urinary Glucose Excretion In patients with type 2 diabetes mellitus, urinary glucose excretion increased immediately following a dose of empagliflozin and was maintained at the end of a 4-week treatment period averaging at approximately 64 grams per day with 10 mg empagliflozin and 78 grams per day with 25 mg empagliflozin once daily [see Clinical Studies (14) ]. Data from single oral doses of empagliflozin in healthy subjects indicate that, on average, the elevation in urinary glucose excretion approaches baseline by about 3 days for the 10 mg and 25 mg doses.

Urinary Volume In a 5-day study, mean 24-hour urine volume increase from baseline was 341 mL on Day 1 and 135 mL on Day 5 of empagliflozin 25 mg once daily treatment. Cardiac Electrophysiology In a randomized, placebo-controlled, active-comparator, crossover study, 30 healthy subjects were administered a single oral dose of empagliflozin 25 mg, empagliflozin 200 mg (8 times the maximum dose), moxifloxacin, and placebo. No increase in QTc was observed with either 25 mg or 200 mg empagliflozin.

12.3Pharmacokinetics The pharmacokinetics of empagliflozin has been characterized in healthy volunteers and patients with type 2 diabetes mellitus and no clinically relevant differences were noted between the two populations. The steady-state mean plasma AUC and C max were 1,870 nmol∙h/L and 259 nmol/L, respectively, with 10 mg empagliflozin once daily treatment, and 4,740 nmol∙h/L and 687 nmol/L, respectively, with 25 mg empagliflozin once daily treatment. Systemic exposure of empagliflozin increased in a dose-proportional manner in the therapeutic dose range.

Empagliflozin does not appear to have time-dependent pharmacokinetic characteristics. Following once-daily dosing, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state. Absorption After oral administration, peak plasma concentrations of empagliflozin were reached at 1.5 hours post-dose.

Administration of 25 mg empagliflozin after intake of a high-fat and high-calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and C max decreased by approximately 37%, compared to fasted condition. The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food. Distribution The apparent steady-state volume of distribution was estimated to be

73.8L based on a population pharmacokinetic analysis. Following administration of an oral [ 14 C]-empagliflozin solution to healthy subjects, the red blood cell partitioning was approximately 36.8% and plasma protein binding was 86.2%. Elimination The apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 h and apparent oral clearance was

10.6L/h based on the population pharmacokinetic analysis. Metabolism No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-O-, 3-O-, and 6-O-glucuronide). Systemic exposure of each metabolite was less than 10% of total drug-related material.

In vitro studies suggested that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9. Excretion Follow…

🧬 Mechanism of Action 84 words ▾

12.1Mechanism of Action Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.

This may influence several physiological functions such as lowering both pre- and afterload of the heart and downregulating sympathetic activity.

📦 How Supplied / Storage and Handling 25 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-4492 NDC: 50090-4492-0 90 TABLET, FILM COATED in a BOTTLE NDC: 50090-4492-1 30 TABLET, FILM COATED in a BOTTLE

📦 Storage and Handling 15 words ▾

Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

📋 Description 132 words ▾

11 DESCRIPTION JARDIANCE tablets for oral use contain empagliflozin, an inhibitor of the SGLT2. The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S). Its molecular formula is C 23 H 27 ClO 7 and the molecular weight is 450.91.

The structural formula is: Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile, soluble in 50% acetonitrile/water, and practically insoluble in toluene. Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.

In addition, the film coating contains the following inactive ingredients: hypromellose, polyethylene glycol, talc, titanium dioxide, and yellow ferric oxide. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Ketoacidosis Inform patients that ketoacidosis is a serious life-threatening condition and that cases of ketoacidosis have been reported during use of JARDIANCE, sometimes associated with illness or surgery among other risk factors. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated.

If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue JARDIANCE and seek medical attention immediately [see Warnings and Precautions (5.1) ] . Volume Depletion Inform patients that symptomatic hypotension may occur with JARDIANCE 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 maintain 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 if such symptoms occur [see Warnings and Precautions (5.3) ] .

Hypoglycemia Inform patients that hypoglycemia has been reported when JARDIANCE is used with insulin secretagogues or insulin. Hypoglycemia may occur in pediatric patients regardless of concomitant antidiabetic treatment. Educate patients or caregivers on the signs and symptoms of hypoglycemia [see Warnings and Precautions (5.4) ] .

Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) Inform patients that necrotizing infections of the perineum (Fournier's gangrene) have occurred with JARDIANCE. Counsel 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 (5.5) ] . Genital Mycotic Infections in Females (e.g., Vulvovaginitis) Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections.

Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.6) ] . Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis) Inform male patients that yeast infection of the penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with chronic and recurrent infections. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis).

Advise them of treatment options and when to seek medical advice [see Warnings and Precautions (5.6) ] . Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions, such as urticaria and angioedema, have been reported with JARDIANCE. Advise patients to report immediately any skin reaction or angioedema, and to discontinue drug until they have consulted prescribing healthcare provider [see Warnings and Precautions (5.7) ] .

Laboratory Tests Inform patients that elevated glucose in urinalysis is expected when taking JARDIANCE [see Drug Interactions (7) ] . Pregnancy Advise pregnant patients, and patients of reproductive potential, of the potential risk to a fetus with treatment with JARDIANCE [see Use in Specific Populations (8.1) ] . Instruct patients to report pregnancies to their healthcare provider as soon as possible.

Lactation Advise patients that breastfeeding is not recommended during treatment with JARDIANCE [see Use in Specific Populations (8.2) ]. Missed Dose Instruct patients to take JARDIANCE only as prescribed. If a dose is missed, it should be taken as soon as the patient remembers.

Advise patients not to double their…

💬 Medication Guide ~3 min read ▾

This MEDICATION GUIDE has been approved by the U.S. Food and Drug Administration. Revised: June 2023 MEDICATION GUIDE JARDIANCE ® (jar DEE ans) (empagliflozin tablets) for oral use What is the most important information I should know about JARDIANCE?

JARDIANCE can cause serious side effects, including: Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with JARDIANCE. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE.

Ketoacidosis is a serious condition, which needs to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with JARDIANCE even if your blood sugar is less than 250 mg/dL.

Stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing If you get any of these symptoms during treatment with JARDIANCE, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL. Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt).

Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden worsening of kidney function in people who are taking JARDIANCE. You may be at higher risk of dehydration if you: take medicines to lower your blood pressure, including diuretics (water pills) are on low sodium (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.

Talk to your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you are sick or cannot eat, or start to lose liquids from your body, for example from vomiting, diarrhea or being in the sun too long. What is JARDIANCE? JARDIANCE is a prescription medicine used to: reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body. reduce the risk of cardiovascular death in adults with type 2 diabetes and who also have known cardiovascular disease. lower blood sugar along with diet and exercise in adults and children who are 10 years of age and older with type 2 diabetes.

JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in blood or urine). JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.

It is not known if JARDIANCE is safe and effective in children under 10 years of age. Who should not take JARDIANCE? Do not take JARDIANCE if you: are allergic to empagliflozin or any of the ingredients in JARDIANCE.

See the end of this Medication Guide for a complete list of ingredients in JARDIANCE. Symptoms of a serious allergic reaction to JARDIANCE may include: swelling of your face, lips, throat and other areas of your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) If you have any of these symptoms, stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room. are on dialysis. What should I tell my healthcare provider before taking JARDIANCE?

Before taking JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems. have liver problems. have a history of infection of the vagina or penis. have a history of urinary tract infections or problems with urination. are going to have surgery. Your healthcare provider may stop your JARDIANCE before you have surgery. Talk to your…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.