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Lisinopril 20 mg Tablet, 90-count

by Lupin Pharmaceuticals, Inc. · 90 TABLET in 1 BOTTLE (68180-981-09)

NDC 68180-0981-09

🏷️ FDA NDC (as labeled) 68180-981-09 billing pads the product segment with a zero

This package

Contains90-count Pack sizes6 compare ↓

Also comes in: 100 tablets 68180-0981-01 500 tablets 68180-0981-02 1000 tablets 68180-0981-03 5000 tablets 68180-0981-05 5000 tablets 68180-0981-30

Rx only Generic 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 Dr. Brian Staiger, PharmD

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

Past resolved recalls for this product (1)

Class II · Sep 13, 2022 · Terminated — Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. (Lupin Pharmaceuticals Inc.) · FDA recall D-1536-2022

🆔 Identity & classification

FDA NDC (as labeled) 68180-981-09

Product NDC 68180-981

11-digit billing NDC 68180098109

RxCUI 197884, 205326, 311353, 311354, 314076, 314077

UNII E7199S1YWR

UPC 0368180513018, 0368180512028, 0368180513032

Application # ANDA077321

SPL Set ID 7d6c31e2-b5a4-4279-8013-a8dad37ea73b

Established class (EPC) Angiotensin Converting Enzyme Inhibitor

Mechanism of action Angiotensin-converting Enzyme Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2017-05-12

Route ORAL

Dosage form TABLET

Substance LISINOPRIL

GPI-14 36100030000315

GPI class Lisinopril

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68180-981-09 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68180-0981-09. 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 Angiotensin Converting Enzyme Inhibitor class.

Pharmacologic class Angiotensin Converting Enzyme Inhibitor

Drug family (ATC) ACE inhibitors, plain

How it works Angiotensin-converting Enzyme 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

LabelerLupin Pharmaceuticals, Inc.

Application holderLUPIN LTD

FDA applicationANDA077321 (ANDA)

Labeler code68180

First marketedMay 2017

Product typeHuman Prescription Drug

Portfolio404 products on file

🔎 All NDCs from Lupin Pharmaceuticals, Inc.

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

📖 What it is MedlinePlus · NLM

Lisinopril is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years of age and older. It is used in combination with other medications to treat heart failure. Lisinopril is also used to improve survival after a heart attack. Lisinopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently. High blood pressure is a common condition and when not treated, can cause...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Lisinopril is mainly prescribed to treat high blood pressure — it relaxes your blood vessels so your heart doesn't have to work as hard. It's also used to help manage heart failure...
Good news — food doesn't affect how lisinopril works, so you can take it with or without a meal. What matters most is taking it at roughly the same time each day. Once a day is the...
Can I take lisinopril with food, or does it have to be on an empty stomach?
Yes, that cough is one of the most well-known side effects of ACE inhibitors like lisinopril. It happens because the medicine also affects a chemical in the lungs called bradykinin...

📖 Read our full Lisinopril guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Lisinopril — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Lisinopril (167 interactions) — ranked by severity →

Nutrient depletion considerations

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

COENZYME Q10 Insufficient Evidence

🧪 Full Lisinopril 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 White / Pink / Yellow / Red

ShapeRound

ImprintLUPIN;30

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII 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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per each	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 100 tablets 500 tablets 1000 tablets 5000 tablets 5000 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Lisinopril 20 mg 00591-0408-01	Actavis	100 tablets	$0.026	—	Availability likely	—
Lisinopril 20 mg 00904-6799-61	Major	100 tablets	$0.026	AB	Availability likely	—
lisinopril 20 mg 23155-0879-01	Heritage	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 31722-0178-01	Camber	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 60687-0333-01	American	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 62135-0643-31	Chartwell	300 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 68001-0335-00	BluePoint	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 68645-0611-90	Legacy	90 tablets	$0.026	AB	Availability likely	—
lisinopril 20 mg 76282-0420-01	Exelan	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 76282-0731-01	Exelan	100 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 82009-0065-10	Quallent	1000 tablets	$0.026	AB	Availability likely	—
Lisinopril 20 mg 00615-8255-05	NCS	15 tablets	—	AB	FDA listed	—
Zestril 20 mg 24979-0241-07	Upsher-Smith	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 42708-0032-30	QPharma	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 42708-0142-30	QPharma,	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 42708-0165-30	QPharma,	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 43063-0786-14	PD-Rx	14 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 43063-0813-01	PD-Rx	100 tablets	—	AB	FDA listed	—
lisinopril 20 mg 43353-0271-30	Aphena	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 43547-0354-03	Solco	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 43547-0417-04	Solco	45 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 50090-4725-00	A-S	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 50090-4887-00	A-S	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 51655-0411-26	Northwind	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 51655-0994-26	Northwind	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 55154-2128-00	Cardinal	10 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 55154-2329-00	Cardinal	10 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 60760-0359-30	St.	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 63187-0257-30	Proficient	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 63187-0442-00	Proficient	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 63187-0775-00	Proficient	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 65862-0040-00	Aurobindo	100 tablets	—	—	FDA listed	—
Lisinopril 20 mg 67046-0423-03	Coupler	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 67296-1202-03	RedPharm	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-1775-01	NuCare	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-3178-00	NuCare	200 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-3409-02	NuCare	120 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-5036-01	NuCare	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-5098-09	NuCare	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68071-5143-01	NuCare	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mgthis 68180-0981-09	Lupin	90 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 68788-6920-01	Preferred	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 70518-0544-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 70518-0845-02	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 70518-1156-01	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Lisinopril 20 mg 71205-0180-00	Proficient	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 71335-0015-01	Bryant	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 71610-0733-15	Aphena	15 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 72789-0093-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 72865-0211-01	XLCare	100 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 76420-0343-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Lisinopril 20 mg 87441-0048-01	Unit	30 tablets	—	AB	FDA listed	—

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

Where does this data come from?

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

⏳ Availability & generic status

🏛️

2017

On the market since

May 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

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

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.

1000 tablets68180-0981-03 991,441 Rx · $8,820,857

100 tablets68180-0981-01 92,321 Rx · $817,814

5000 tablets68180-0981-30 40 Rx · $428

500 tablets68180-0981-02 No Medicaid data

5000 tablets68180-0981-05 No Medicaid data

90 tablets this page68180-0981-09 No Medicaid data

Drug total (last 4 qtrs): 1,083,802 Rx · 61,967,435 units · $9,639,099 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 Lisinopril — the program that covers self-administered drugs. 13 manufacturers.

⚠️ 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 Lisinopril. 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

$64.63M

Claims incl. refills

8.5M

Beneficiaries

6.7M

Spend / beneficiary

$9.67

Spend / claim

$7.59

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 LISINOPRIL — the ingredient across all brands.

Top reported reactions

Fatigue20,515

Nausea19,130

Diarrhoea17,858

Dyspnoea14,363

Pain14,067

Dizziness13,969

Headache13,419

Age at onset

Neonate109

Infant9

Child64

Adolescent126

Adult21,399

Elderly21,453

Reporter sex

Male · 48%

Female · 52%

Unknown · 0%

Serious outcomes

Hospitalization100,561

Disabling9,800

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

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

Where does this data come from?

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

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
68180-0981-01	100 TABLET in 1 BOTTLE (68180-981-01)	$0.0257 / ea	$2.57	2017-05-12	Active
68180-0981-02	500 TABLET in 1 BOTTLE (68180-981-02)	—	—	2017-05-12	Active
68180-0981-03	1000 TABLET in 1 BOTTLE (68180-981-03)	$0.0257 / ea	$25.72	2017-05-12	Active
68180-0981-05	5000 TABLET in 1 BOTTLE (68180-981-05)	—	—	2017-05-12	Active
68180-0981-09 You're viewing this	90 TABLET in 1 BOTTLE (68180-981-09)	—	—	2017-05-12	Active
68180-0981-30	5000 TABLET in 1 POUCH (68180-981-30)	$0.0257 / ea	$128.60	2017-05-12	Active

This pack shows little to no recent Medicaid volume — the 1000 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 68180-0981-09?

NDC 68180-0981-09 is a 90-count package — 90 tablet in 1 bottle.

What is the difference between NDC 68180-0981-09 and NDC 68180-0981-01?

Both are Lisinopril 20 mg Tablet — the drug itself is identical. NDC 68180-0981-09 is the 90-count package, while NDC 68180-0981-01 is the 100 tablets package.

What NDC number is used to bill for this package of Lisinopril 20 mg Tablet?

Bill NDC 68180-0981-09 — the 11-digit billing format is 68180098109. 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

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 68180-981-09, 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: 68180-0981-09, written without dashes as 68180098109. 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 68180-0981-09, the first segment (68180) is the labeler code FDA assigned to Lupin Pharmaceuticals, Inc.; the middle segment (0981) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 5 other package presentations of this same product, including 100 tablets (68180-0981-01), 500 tablets (68180-0981-02), 1000 tablets (68180-0981-03). 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?

Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 90 words ▾

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

( 5.1 ) WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.1 )] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS ( 5.1 )] .

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 )

1.1Hypertension Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Lisinopril tablets USP may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES ( 14.1 )] .

1.2Heart Failure Lisinopril tablet USP is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES ( 14.2 )] .

1.3Reduction of Mortality in Acute Myocardial Infarction Lisinopril tablet USP is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES ( 14.3 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40 mg daily based on blood pressure response. Initiate patients on diuretics at 5 mg once daily ( 2.1 ) Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 : Initial dose in patients 6 years of age and older is 0.07 mg per kg (up to 5 mg total) once daily ( 2.1 ) Heart Failure: Initiate with 5 mg once daily.

Increase dose as tolerated to 40 mg daily ( 2.2 ) Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI. Followed by 5 mg after 24 hours, then 10 mg once daily ( 2.3) Renal Impairment: For patients with creatinine clearance > 10 mL/min and < 30 mL/min, halve usual initial dose. For patients with creatinine clearance < 10 mL/min or on hemodialysis, the recommended initial dose is 2.5 mg ( 2.4 )

2.1Hypertension Initial Therapy in adults: The recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 20 mg to 40 mg per day administered in a single daily dose.

Doses up to 80 mg have been used but do not appear to give greater effect. Use with Diuretics in Adults If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (e.g, hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril.

The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day. Pediatric Patients 6 Years of Age and Older with Hypertension For pediatric patients with glomerular filtration rate > 30 mL/min/1.73m 2 , the recommended starting dose is 0.07 mg per kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg per kg (up to 40 mg) once daily.

Doses above 0.61 mg per kg (or in excess of 40 mg) have not been studied in pediatric patients [see CLINICAL PHARMACOLOGY ( 12.3 )] . Lisinopril tablet USP is not recommended in pediatric patients < 6 years or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73m 2 [see USE IN SPECIFIC POPULATIONS ( 8.4 ) and CLINICAL STUDIES ( 14.1 )] .

2.2Heart Failure The recommended starting dose for lisinopril, when used with diuretics and (usually) digitalis as adjunctive therapy for systolic heart failure, is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium < 130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.

Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see WARNINGS AND PRECAUTIONS ( 5.4 ), and DRUG INTERACTIONS ( 7.1 )] . The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

2.3Reduction of Mortality in Acute Myocardial Infarction In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give lisinopril tablets USP 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least six weeks. Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (≤ 120 mmHg and > 100 mm Hg) during the first 3 days after the infarct [see WARNINGS AND PRECAUTIONS ( 5.4 )] .

If hypotension occurs (systolic blood pressure ≤ 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) lisinopril should be withdrawn.

2.4Dose in Patients with Renal Impairment No dose adjustment of lisinopril is required in patients with creatinine clearance > 30 mL/min. In patients with creatinine clearance ≥ 10 mL/min and ≤ 30 mL/min, reduce the initial dose of lisinopril to half of the usual recommended dose…

💊 Dosage Forms and Strengths 154 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg ( 3 ) 2.5 mg tablet is a white to off-white, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "2.5" on other side. 5 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "5" debossed on one side and breakline on other side. 10 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "10" on other side.

20 mg tablet is a pink coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "20" on other side. 30 mg tablet is a red coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "30" on other side. 40 mg tablet is a yellow coloured, round, biconvex, uncoated tablet with "LUPIN" debossed on one side and "40" on other side.

⛔ Contraindications 110 words ▾

4 CONTRAINDICATIONS Angioedema or a history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Co-administration of aliskiren with lisinopril in patients with diabetes ( 4 , 7.4 ) Lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril tablet USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see WARNINGS and PRECAUTIONS ( 5.2 )]. Lisinopril is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema Do not co-administer aliskiren with lisinopril in patients with diabetes [see DRUG INTERACTIONS ( 7.4 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved ( 5.2 ) Renal impairment: Monitor renal function periodically ( 5.3 ) Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation ( 5.4) Hyperkalemia: Monitor serum potassium periodically ( 5.5 ) Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure ( 5.6 )

5.1Fetal Toxicity Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.

Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue lisinopril as soon as possible [see USE IN SPECIFIC POPULATIONS ( 8.1 )] .

5.2Angioedema and Anaphylactoid Reactions Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema. [see DRUG INTERACTIONS ( 7.7 , 7.8 )]. Angioedema Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including lisinopril, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery.

Lisinopril should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor [see CONTRAINDICATIONS ( 4 )]. ACE inhibitors have been associated with a higher rate of angioedema in black than in non-black patients.

Intestinal Angioedema : Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.

Anaphylactoid Reactions Anaphylactoid Reactions During Desensitization: Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. Anaphylactoid Reactions During Dialysis : Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated.

Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

5.3Impaired Renal Function Monitor renal function periodically in patients treated with lisinopril. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Common adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ) Heart Failure: hypotension and chest pain ( 6.1 ) Acute Myocardial Infarction: hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Hypertension In clinical trials in patients with hypertension treated with lisinopril, 5.7% of patients on lisinopril discontinued with adverse reactions. The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril alone: headache (by 3.8%), dizziness (by 3.5%), cough (by 2.5%).

Heart Failure In patients with systolic heart failure treated with lisinopril for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was discontinued in 8.1% of patients treated with lisinopril for 12 weeks, compared to 7.7% of patients treated with placebo for 12 weeks. The following adverse reactions (events 2% greater on lisinopril than on placebo) were observed with lisinopril: hypotension (by 3.8%), chest pain (by 2.1%).

In the two-dose ATLAS trial [see CLINICAL STUDIES ( 14.2 )] in heart failure patients, withdrawals due to adverse reactions were not different between the low and high groups, either in total number of discontinuation (17 to 18%) or in rare specific reactions (< 1%). The following adverse reactions, mostly related to ACE inhibition, were reported more commonly in the high dose group: Table 1 Dose-related Adverse Drug Reactions: ATLAS trial High Dose ( n = 1568 ) Low Dose ( n = 1596 ) Dizziness 19% 12% Hypotension 11% 7% Creatinine increased 10% 7% Hyperkalemia 6% 4% Syncope 7% 5% Acute Myocardial Infarction Patients treated with lisinopril had a higher incidence of hypotension (by 5.3%) and renal dysfunction (by 1.3%) compared with patients not taking lisinopril.

Other clinical adverse reactions occurring in 1 % or higher of patients with hypertension or heart failure treated with lisinopril in controlled clinical trials and do not appear in other sections of labeling are listed below: Body as a whole: Fatigue, asthenia, orthostatic effects. Digestive: Pancreatitis, constipation, flatulence, dry mouth, diarrhea. Hematologic: Rare cases of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia.

Endocrine: Diabetes mellitus, inappropriate antidiuretic hormone secretion. Metabolic: Gout. Skin: Urticaria, alopecia, photosensitivity, erythema, flushing, diaphoresis, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens-Johnson syndrome, and pruritus.

Special Senses: Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste disturbances, olfactory disturbance. Urogenital: Impotence. Miscellaneous: A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia, fever, vasculitis, eosinophilia, leukocytosis, paresthesia and vertigo.

Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms. Clinical Laboratory Test Findings Serum Potassium: In clinical trials hyperkalemia (serum potassium greater than 5.7 mEq/L) occurred in 2.2% and 4.8% of lisinopril-treated patients with hypertension and heart failure, respectively [see WARNINGS AND PRECAUTIONS ( 5.5 )] . Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 2% of patients with hypertension treated with li…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Diuretics: Excessive drop in blood pressure ( 7.1 ) NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.5 ) Gold: Nitritoid reactions have been reported ( 7.6 ) Concomitant mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk ( 7.7 , 7.8 )

7.1Diuretics Initiation of lisinopril in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with lisinopril can be minimized by either decreasing or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril. If this is not possible, reduce the starting dose of lisinopril tablets [see DOSAGE AND ADMINISTRATION ( 2.2 ) and WARNINGS AND PRECAUTIONS ( 5.4 )] .

Lisinopril attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient's serum potassium frequently.

7.2Antidiabetics Concomitant administration of lisinopril and antidiabetic medicines (insulins, oral hypoglycemic agents) may cause an increased blood-glucose-lowering effect with risk of hypoglycemia.

7.3Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.

The antihypertensive effect of ACE inhibitors, including lisinopril, may be attenuated by NSAIDs.

7.4Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years.

Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on lisinopril and other agents that affect the RAS.

Do not co-administer aliskiren with lisinopril in patients with diabetes. Avoid use of aliskiren with lisinopril in patients with renal impairment (GFR <60 ml/min).

7.5Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs, which cause elimination of sodium, including ACE inhibitors. Lithium toxicity was usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.

7.6Gold Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including lisinopril. 7.7 mTOR Inhibitors Patients taking concomitant mTOR inhibito…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 ) Race: Less antihypertensive effect in blacks than non blacks ( 8.6 )

8.1Pregnancy Risk Summary Lisinopril can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

When pregnancy is detected, discontinue lisinopril as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the general U.S. 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: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly.

Fetal/Neonatal Adverse Reactions: Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia and skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.

Closely observe infants with histories of in utero exposure to lisinopril for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occur in neonates with a history of in utero exposure to lisinopril, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and substituting for disordered renal function.

8.2Lactation Risk Summary No data are available regarding the presence of lisinopril in human milk or the effects of lisinopril on the breast fed infant or on milk production. Lisinopril is present in rat milk. Because of the potential for severe adverse reactions in the breastfed infant, advise women not to breastfeed during treatment with lisinopril.

8.4Pediatric Use Antihypertensive effects and safety of lisinopril have been established in pediatric patients aged 6 to 16 years [see DOSAGE AND ADMINISTRATION ( 2.1 ) and CLINICAL STUDIES ( 14.1 )] . No relevant differences between the adverse reaction profile for pediatric patients and adult patients were identified. Safety and effectiveness of lisinopril have not been established in pediatric patients under the age 6 or in pediatric patients with glomerular filtration rate < 30 mL/min/1.73 m 2 [see DOSAGE AND ADMINISTRATION ( 2.1 ), CLINICAL PHARMACOLOGY ( 12.3 ), and CLINICAL STUDIES ( 14.1 )] .

Neonates with A History of In Utero Exposure to Lisinopril If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal fun…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 142 words ▾

🧓 Geriatric Use 91 words ▾

8.5Geriatric Use No dosage adjustment with lisinopril is necessary in elderly patients. In a clinical study of lisinopril in patients with myocardial infarctions (GISSI-3 Trial) 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over. In this study, 4.8 % of patients aged 75 years and older discontinued lisinopril treatment because of renal dysfunction vs.

1.3% of patients younger than 75 years. No other differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE Following a single oral dose of 20 g/kg no lethality occurred in rats, and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Lisinopril can be removed by hemodialysis [see CLINICAL PHARMACOLOGY ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.

The beneficial effects of lisinopril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium.

In hypertensive patients with normal renal function treated with lisinopril alone for up to 24 weeks, the mean increase in serum potassium was approximately 0.1 mEq/L; however, approximately 15% of patients had increases greater than 0.5 mEq/L and approximately 6% had a decrease greater than 0.5 mEq/L. In the same study, patients treated with lisinopril and hydrochlorothiazide for up to 24 weeks had a mean decrease in serum potassium of 0.1 mEq/L; approximately 4% of patients had increases greater than 0.5 mEq/L and approximately 12% had a decrease greater than 0.5 mEq/L [see CLINICAL STUDIES ( 14.1 )] .

Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of lisinopril remains to be elucidated.

While the mechanism through which lisinopril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, lisinopril is antihypertensive even in patients with low-renin hypertension. Although lisinopril was antihypertensive in all races studied, Black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to monotherapy than non Black patients. Concomitant administration of lisinopril and hydrochlorothiazide further reduced blood pressure in Black and non-Black patients and any racial differences in blood pressure response were no longer evident.

12.2Pharmacodynamics Hypertension Adult Patients: Administration of lisinopril to patients with hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is usually not observed although it can occur and should be anticipated in volume and/or salt-depleted patients [see WARNINGS AND PRECAUTIONS ( 5.4 )] . When given together with thiazide-type diuretics, the blood pressure lowering effects of the two drugs are approximately additive.

In most patients studied, onset of antihypertensive activity was seen at one hour after oral administration of an individual dose of lisinopril, with peak reduction of blood pressure achieved by 6 hours. Although an antihypertensive effect was observed 24 hours after dosing with recommended single daily doses, the effect was more consistent and the mean effect was considerably larger in some studies with doses of 20 mg or more than with lower doses; however, at all doses studied, the mean antihypertensive effect was substantially smaller 24 hours after dosing than it was 6 hours after dosing.

The antihypertensive effects of lisinopril are maintained during long-term therapy. Abrupt withdrawal of lisinopril has not been associated with a rapid increase in blood pressure, or a significant increase in blood pressure compared to pretreatment levels. Non-Steroidal Anti-Inflammatory Agents In a study in 36 patients with mild to moderate hypertension where the antihypertensive effects of lisinopril alone were compared to lisinopril given concomitantly with indomethacin, the use of indomethacin was associated with a reduced effect, although th…

🧬 Mechanism of Action ~1 min read ▾

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lisinopril tablet USP is available as uncoated biconvex tablets in bottles of below mentioned pack size Strength Color Shape Scored Side 1/Side 2 NDC 2.5 mg White to off-white Round No LUPIN/2.5 Bottles of 100: 68180-512-01 Bottles of 500: 68180-512-02 5 mg Pink Round Yes 5/Breakline Bottles of 100: 68180-513-01 Bottles of 1000: 68180-513-03 10 mg Pink Round No LUPIN/10 Bottles of 100: 68180-980-01 Bottles of 1000: 68180-980-03 20 mg Pink Round No LUPIN/20 Bottles of 100: 68180-981-01 Bottles of 1000: 68180-981-03 30 mg Red Round No LUPIN/30 Bottles of 100: 68180-982-01 Bottles of 500: 68180-982-02 40 mg Yellow Round No LUPIN/40 Bottles of 100: 68180-979-01 Bottles of 1000: 68180-979-03 Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].

Protect from moisture, freezing and excessive heat. Dispense in a tight container.

📋 Description 163 words ▾

11 DESCRIPTION Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 2H 2 O and its structural formula is: Lisinopril is a white, crystalline powder, with a molecular weight of 441.53.

It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn).

5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn). Lisinopril

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Pregnancy Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS ( 5.1 ) and USE IN SPECIFIC POPULATIONS ( 8.1 )]. Angioedema Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Lactation Advise women not to breastfeed during treatment with lisinopril [see USE IN SPECIFIC POPULATIONS ( 8.2 )]. Symptomatic Hypotension Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly. Hyperkalemia Tell patients not to use salt substitutes containing potassium without consulting their physician.

Hypoglycemia Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycaemia closely, especially during the first month of combined use [see DRUG INTERACTIONS ( 7.2 )] . Leukopenia/Neutropenia Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.

Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States. MADE IN INDIA Revised: June 2024 ID#: 276103 Image

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

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

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

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

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

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

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

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

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

anuria: Producing little or no urine, which can be a sign of severe kidney problems.

arthralgia: Joint pain.

asthenia: Unusual weakness or lack of physical strength and energy.

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

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

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

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

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

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

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

depression: A lasting low mood with loss of interest that affects everyday life.

desensitization: A medical process of giving tiny, slowly increasing doses to help the body tolerate a substance it reacts to.

diaphoresis: Heavy or excessive sweating.

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

diplopia: Double vision, or seeing two images of a single object.

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

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

edema: Swelling caused by extra fluid trapped in the body's tissues.

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

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

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

enzyme inhibitor: A substance that blocks or slows a body enzyme, which can let other medicines build up to higher levels.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

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

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

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

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

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

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

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

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

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

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

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

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

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

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

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

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

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

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

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

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

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

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

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

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

monotherapy: Treatment using a single medicine by itself.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

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

neonatal: Relating to a newborn baby during its first four weeks of life.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

oliguria: Producing much less urine than normal, which is often a sign the kidneys are under stress.

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

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

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

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

photophobia: Discomfort or pain in the eyes when exposed to light.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

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

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

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

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

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

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

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

urticaria: Raised, itchy welts on the skin, commonly called hives.

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

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

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

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 68180-0980-01 · Lupin 68180-0982-01 · Lupin →

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.

Lisinopril 20 mg Tablet, 90-count

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