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Lisinopril 5 mg Tablet, 300-count — NDC 62135-0641-31 package photo

Lisinopril 5 mg Tablet, 300-count

by Chartwell RX, LLC · 300 TABLET in 1 BOTTLE (62135-641-31)
NDC 62135-0641-31
🏷️ FDA NDC (as labeled) 62135-641-31 billing pads the product segment with a zero
This package
Contains300-count Cost per ea$0.0143 NADAC Per package$4.29 / 300 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2390/unit · Part D plans $0.1245/unit — full pricing hub ↓
Also comes in: 90 tablets 62135-0641-90
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

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

🆔 Identity & classification

FDA NDC (as labeled) 62135-641-31
Product NDC 62135-641
11-digit billing NDC 62135064131
NCPDP billing unit EA — each (per item)
RxCUI 197884, 205326, 311353, 311354, 314076, 314077
UNII E7199S1YWR
UPC 0362135641313, 0362135643317, 0362135641900, 0362135645311 +8 more
Application # ANDA212041
SPL Set ID 8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce
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 2020-09-15
Route ORAL
Dosage form TABLET
Substance LISINOPRIL
GPI-14 36100030000305
GCN Seq No 000393
GCN 47260
HICL code 000132
Ingredient (HICL) Lisinopril
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4D
Therapeutic class — specific (HIC3) Antihypertensives, Ace Inhibitors
AHFS code 24:32.04.00
AHFS class Angiotensin-Converting Enzyme Inhibitors
FDB label name LISINOPRIL 5 MG TABLET
FDB brand name Lisinopril
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62135-641-31 — 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 → 62135-0641-31. 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

LabelerChartwell RX, LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA212041 (ANDA)
Labeler code62135
First marketedSep 2020
Product typeHuman Prescription Drug
Portfolio521 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 LISINOPRIL 5 MG TABLET Ingredient Lisinopril
📖 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 →
1
Nutrient depletion considerations

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

🧪 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 / yellow / pink
ShapeRound
ImprintY16
Size8 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 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 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.014 $4.29 / 300 tablets
Medicaid paysCMS SDUD · 12 mo $0.2390 $71.70 / 300 tablets
Medicare drug plans payPart D · Q2 2026 $0.1245 $37.35 / 300 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.015 $0.014
▼ Down 1% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lisinopril 5 mg 00591-0406-01 Actavis 100 tablets $0.014 — Availability likely —
Lisinopril 5 mg 00904-6797-61 Major 100 tablets $0.014 AB Availability likely —
lisinopril 5 mg 23155-0877-01 Heritage 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 31722-0176-01 Camber 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 43547-0352-10 Solco 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 60687-0667-01 American 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mgthis 62135-0641-31 Chartwell 300 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 68001-0333-00 BluePoint 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 68180-0513-01 Lupin 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 68645-0609-90 Legacy 90 tablets $0.014 AB Availability likely —
lisinopril 5 mg 76282-0418-01 Exelan 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 76282-0729-01 Exelan 100 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 82009-0063-10 Quallent 1000 tablets $0.014 AB Availability likely —
Lisinopril 5 mg 00615-8253-05 NCS 15 tablets — AB FDA listed —
Zestril 5 mg 24979-0239-07 Upsher-Smith 90 tablets — AB FDA listed —
Lisinopril 5 mg 43063-0074-30 PD-Rx 30 tablets — AB FDA listed —
Lisinopril 5 mg 43063-0811-01 PD-Rx 100 tablets — AB FDA listed —
lisinopril 5 mg 43353-0298-30 Aphena 30 tablets — AB FDA listed —
Lisinopril 5 mg 43547-0415-03 Solco 30 tablets — AB FDA listed —
Lisinopril 5 mg 50090-3765-00 A-S 30 tablets — AB FDA listed —
Lisinopril 5 mg 50090-6912-00 A-S 90 tablets — AB FDA listed —
Lisinopril 5 mg 51655-0232-26 Northwind 90 tablets — AB FDA listed —
Lisinopril 5 mg 51655-0486-26 Northwind 90 tablets — AB FDA listed —
Lisinopril 5 mg 55154-8096-00 Cardinal 10 tablets — AB FDA listed —
Lisinopril 5 mg 55289-0884-30 PD-Rx 30 tablets — AB FDA listed —
Lisinopril 5 mg 60760-0357-90 St. 90 tablets — — FDA listed —
Lisinopril 5 mg 63187-0534-30 Proficient 30 tablets — — FDA listed —
Lisinopril 5 mg 63629-1761-01 Bryant 30 tablets — AB FDA listed —
Lisinopril 5 mg 65862-0038-00 Aurobindo 100 tablets — — FDA listed —
Lisinopril 5 mg 67046-0858-03 Coupler 30 tablets — AB FDA listed —
Lisinopril 5 mg 68071-2224-03 NuCare 30 tablets — AB FDA listed —
Lisinopril 5 mg 68071-3123-01 NuCare 120 tablets — — FDA listed —
Lisinopril 5 mg 68071-4660-01 NuCare 120 tablets — AB FDA listed —
Lisinopril 5 mg 68071-4858-01 NuCare 100 tablets — — FDA listed —
Lisinopril 5 mg 68071-5089-01 NuCare 100 tablets — AB FDA listed —
Lisinopril 5 mg 68788-8562-01 Preferred 100 tablets — — FDA listed —
Lisinopril 5 mg 70518-1906-01 REMEDYREPACK 30 tablets — AB FDA listed —
Lisinopril 5 mg 71205-0471-30 Proficient 30 tablets — AB FDA listed —
Lisinopril 5 mg 71205-0626-30 Proficient 30 tablets — AB FDA listed —
Lisinopril 5 mg 71335-0176-01 Bryant 30 tablets — AB Discontinued —
Lisinopril 5 mg 71610-0536-45 Aphena 45 tablets — AB FDA listed —
Lisinopril 5 mg 71610-0588-60 Aphena 90 tablets — — FDA listed —
Lisinopril 5 mg 71610-0766-30 Aphena 30 tablets — AB FDA listed —
Lisinopril 5 mg 72865-0209-01 XLCare 100 tablets — AB FDA listed —
Lisinopril 5 mg 76420-0341-00 Asclemed 1000 tablets — AB FDA listed —
Lisinopril 5 mg 87441-0049-01 Unit 30 tablets — AB FDA listed —
Lisinopril 5 mg 67046-2097-03 Coupler 30 tablets — AB FDA listed —
Lisinopril 5 mg 50090-8007-00 A-S 90 tablets — AB FDA listed —
Lisinopril 5 mg 50090-2228-00 A-S 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62135-0641-31, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
494
Gross reimbursed last 4 qtrs
$118.08
Avg / prescription
$10.73
Avg / unit
$0.2390
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.2390
gross reimbursed
vs
NADAC / ea
$0.0143
acquisition cost
=
Spread
+$0.2247
+1571% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 11 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 494 units · 2.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.52.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 2.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
300 tablets this page62135-0641-31 11 Rx · $118
90 tablets62135-0641-90 No Medicaid data
Drug total (last 4 qtrs): 11 Rx · 494 units · $118 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

313,746 reports
Male · 48%
Female · 52%
Unknown · 0%

Serious outcomes

Hospitalization100,561
Disabling9,800
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 18,580 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 Per unit Per pack Marketing startStatus
62135-0641-31 You're viewing this 300 TABLET in 1 BOTTLE (62135-641-31) $0.0143 / ea $4.30 2023-06-07 Active
62135-0641-90 90 TABLET in 1 BOTTLE (62135-641-90) $0.0143 / ea $1.29 2023-06-07 Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0143 NADAC).

Pack size FAQ

What quantity is in NDC 62135-0641-31?
NDC 62135-0641-31 is a 300-count package — 300 tablet in 1 bottle.
What is the difference between NDC 62135-0641-31 and NDC 62135-0641-90?
Both are Lisinopril 5 mg Tablet — the drug itself is identical. NDC 62135-0641-31 is the 300-count package, while NDC 62135-0641-90 is the 90 tablets package.
What NDC number is used to bill for this package of Lisinopril 5 mg Tablet?
Bill NDC 62135-0641-31 — the 11-digit billing format is 62135064131. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 90 words ▾

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril tablets 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) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue lisinopril tablets 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 )

🎯 Indications and Usage 48 words ▾

1 INDICATIONS AND USAGE Lisinopril tablets 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 )

⏱️ Dosage and Administration 156 words ▾

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 )

💊 Dosage Forms and Strengths 149 words ▾

3 DOSAGE FORMS AND STRENGTHS Lisinopril tablets, USP 2.5 mg are white, round, biconvex, uncoated tablets, engraved with “Y11” on one side. Lisinopril tablets, USP 5 mg are yellow, capsule shape, uncoated tablets, debossed with “Y12” on one side and a functional scoring on another side. Lisinopril tablets, USP 10 mg are yellow, round, biconvex, uncoated tablets, debossed with “Y13” on one side, plain on another side.

Lisinopril tablets, USP 20 mg are yellow, round, biconvex, uncoated tablets, debossed with “Y14” on one side, plain on another side. Lisinopril tablets, USP 30 mg are yellow, round, biconvex, uncoated tablets, debossed with “Y15” on one side, plain on another side. Lisinopril tablets, USP 40 mg are light pink to pink, round, biconvex, uncoated tablets, debossed with “Y16” on one side, plain on another side.

Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg ( 3 )

⛔ Contraindications 110 words ▾

4 CONTRAINDICATIONS Lisinopril tablets are contraindicated in combination with a neprilysin (e.g., sacubitril). Do not administer lisinopril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warning and Precaution (5.2) ]. Lisinopril tablets are 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 tablets in patients with diabetes [see Drug Interactions (7.4) ].

Angioedema or a history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Co-administration of aliskiren with Lisinopril Tablets in patients with diabetes ( 4 , 7.4 )

⚠️ Warnings and Cautions 70 words ▾

5 WARNINGS AND PRECAUTIONS Angioedema: Discontinue Lisinopril Tablets, 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 )

🤒 Adverse Reactions 54 words ▾

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 Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 76 words ▾

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 ).

👥 Use in Specific Populations 25 words ▾

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

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Lisinopril tablets 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 tablets 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 2-4% and 15-20%, 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 tablets for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occur in neonates with a history of in utero exposure to lisinopril tablets, 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.

🧒 Pediatric Use 138 words ▾

8.4Pediatric Use Antihypertensive effects and safety of lisinopril tablets 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 tablets 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 tablets 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 function.

🧓 Geriatric Use 94 words ▾

8.5Geriatric Use No dosage adjustment with lisinopril tablets is necessary in elderly patients. In a clinical study of lisinopril tablets 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 tablets 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 61 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 words ▾

12 CLINICAL PHARMACOLOGY

📦 How Supplied / Storage and Handling 163 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lisinopril tablets, USP are available as uncoated tablets in bottles of 90 and 300. Strength Color Shape Scored Side 1 Bottle Count NDC 2.5 mg White Round No Y11 90 Tablets 62135-640-90 2.5 mg White Round No Y11 300 Tablets 62135-640-31 5 mg Yellow Capsule shape Yes Y12 90 Tablets 62135-641-90 5 mg Yellow Capsule shape Yes Y12 300 Tablets 62135-641-31 10 mg Yellow Round No Y13 90 Tablets 62135-642-90 10 mg Yellow Round No Y13 300 Tablets 62135-642-31 20 mg Yellow Round No Y14 90 Tablets 62135-643-90 20 mg Yellow Round No Y14 300 Tablets 62135-643-31 30 mg Yellow Round No Y15 90 Tablets 62135-644-90 30 mg Yellow Round No Y15 300 Tablets 62135-644-31 40 mg Pink Round No Y16 90 Tablets 62135-645-90 40 mg Pink Round No Y16 300 Tablets 62135-645-31 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature].

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

📋 Description 181 words ▾

11 DESCRIPTION Lisinopril, USP is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, USP a synthetic peptide derivative, is chemically described as (S)-1-[N 2 -(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, USP is a white to off-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: Lisinopril tablets, USP 2.5 mg - dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, magnesium stearate.

Lisinopril tablets, USP 5 mg and 10 mg – dibasic calcium phosphate dihydrate, mannitol, pregelatinized starch-1500, yellow iron oxide, magnesium stearate. Lisinopril Tablets, USP 20 and 30 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, yellow iron oxide. Lisinopril Tablets, USP 40 mg - corn starch, croscarmellose sodium, dibasic calcium phosphate, magnesium sterate, mannitol, red iron oxide. "Image Description"

💬 Information for Patients ~1 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 (eg, sore throat, fever), which may be a sign of leukopenia/neutropenia. Manufactured by: Yiling Pharmaceutical Ltd No.36 Zhujiang Road, Shijiazhuang,050035, China Manufactured for: Chartwell RX, LLC.

Congers, NY 10920 Revised: 06/2023 L71496

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62135-0640-31 · Chartwell 62135-0642-31 · Chartwell →
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.