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Lisinopril 40 mg Tablet, 90-count — NDC 62135-0645-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lisinopril 40 mg Tablet, 90-count — NDC 62135-645-90 (Billing 62135-0645-90)

by Chartwell RX, LLC · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Lisinopril 40 mg Tablet from Chartwell RX, LLC, marketed since Mar 2021 and currently FDA-listed; retail pharmacies pay about $0.0463 per tablet (NADAC).

NDC 62135-0645-90
🏷️ FDA NDC (as labeled) 62135-645-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.0463 NADAC Per package$4.17 / 90 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.1245/unit — full pricing hub ↓
Product page 62135-0645-31 Also comes in: 300 tablets 62135-645-31
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-645-90
Product NDC 62135-645
11-digit billing NDC 62135064590
NCPDP billing unit EA — each (per item)
RxCUI 197884, 205326, 311353, 311354, 314076, 314077
UNII E7199S1YWR
UPC 0362135641313, 0362135643317, 0362135641900, 0362135645311 +8 more
Application # ANDA208920
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 2021-03-04
Route ORAL
Dosage form TABLET
Substance LISINOPRIL
TE code (Orange Book) AB · RLD · RS

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

GPI-14 36100030000330
GCN Seq No 000392
GCN 47263
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 40 MG TABLET
FDB brand name Lisinopril
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000392
  • GCN: 47263
  • GPI-14 (Medi-Span): 36100030000330
  • HICL (First Databank): 000132
  • AHFS class code: 24:32.04.00
  • RxCUI (RxNorm): 197884
Why two NDCs? The FDA registers this code as 62135-645-90 — 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 → 62135-0645-90. 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.

Clinical

Label name LISINOPRIL 40 MG TABLET Ingredient Lisinopril
📗 Our plain-language guide HelloPharmacist
  • It lowers high blood pressure and is used as add-on treatment for heart failure. It is also used soon after a heart attack to improve survival. Lowering blood pressure helps reduce...
  • You usually take it by mouth once a day. Tablets can be taken with or without food. Follow your prescriber's directions, because the dose is adjusted to your blood pressure.
  • Headache, dizziness, cough and tiredness are the most common. Stand up slowly if you feel lightheaded. Tell me or your doctor if they bother you or don't go away.
  • Get emergency help for swelling of the face, lips, tongue or throat, or trouble breathing. Call your doctor for fainting, yellow skin or eyes, severe belly pain, or very little uri...
📖 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.

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 $0.046 $4.17 / 90 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1245 $11.21 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.047 $0.046
▼ Down 1% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
62135-0645-31 62135-645-31 Main listing 300 TABLET in 1 BOTTLE $0.0463 / ea $13.88 2023-06-07 — Active
62135-0645-90 You're viewing this 90 TABLET in 1 BOTTLE $0.0463 / ea $4.16 2023-06-07 — Active

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

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0463 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 62135-0645-31?
Both are Lisinopril 40 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 62135-0645-31 is the 300 tablets package.
What NDC number is used to bill for this package of Lisinopril 40 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lisinopril 40 mg 68180-0517-01 Lupin 100 tablets $0.046 AB Discontinued save 1%
Lisinopril 40 mg 00591-0409-01 Actavis 100 tablets $0.046 — Availability likely —
Lisinopril 40 mg 00904-7200-61 Major 100 tablets $0.046 AB Availability likely —
lisinopril 40 mg 23155-0881-01 Heritage 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 31722-0180-01 Camber 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 43547-0356-10 Solco 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 60687-0678-01 American 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mgthis 62135-0645-90 Chartwell 90 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 68001-0486-00 BluePoint 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 68180-0979-01 Lupin 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 68645-0613-90 Legacy 90 tablets $0.046 AB Availability likely —
lisinopril 40 mg 76282-0422-01 Exelan 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 76282-0733-01 Exelan 100 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 82009-0066-10 Quallent 1000 tablets $0.046 AB Availability likely —
Lisinopril 40 mg 00615-8405-05 NCS 15 tablets — AB FDA listed —
Zestril 40 mg 24979-0243-07 Upsher-Smith 90 tablets — AB FDA listed —
Lisinopril 40 mg 42708-0033-30 QPharma 30 tablets — AB FDA listed —
Lisinopril 40 mg 42708-0096-30 QPharma, 30 tablets — AB FDA listed —
Lisinopril 40 mg 42708-0176-30 QPharma, 30 tablets — AB FDA listed —
Lisinopril 40 mg 43063-0800-30 PD-Rx 30 tablets — AB FDA listed —
Lisinopril 40 mg 43063-0815-01 PD-Rx 100 tablets — AB FDA listed —
lisinopril 40 mg 43353-0009-30 Aphena 30 tablets — AB FDA listed —
Lisinopril 40 mg 43547-0419-04 Solco 45 tablets — AB FDA listed —
Lisinopril 40 mg 50090-3763-00 A-S 30 tablets — AB FDA listed —
Lisinopril 40 mg 50090-7074-00 A-S 90 tablets — AB FDA listed —
Lisinopril 40 mg 50090-7650-00 A-S 90 tablets — AB FDA listed —
Lisinopril 40 mg 51655-0146-26 Northwind 90 tablets — AB FDA listed —
Lisinopril 40 mg 51655-0335-26 Northwind 90 tablets — AB FDA listed —
Lisinopril 40 mg 55700-0547-30 Quality 30 tablets — AB Discontinued —
Lisinopril 40 mg 60760-0360-30 St. 30 tablets — AB FDA listed —
Lisinopril 40 mg 63187-0237-30 Proficient 30 tablets — AB FDA listed —
Lisinopril 40 mg 63187-0825-30 Proficient 30 tablets — AB FDA listed —
Lisinopril 40 mg 65862-0042-00 Aurobindo 100 tablets — — FDA listed —
Lisinopril 40 mg 68071-3064-02 NuCare 120 tablets — AB FDA listed —
Lisinopril 40 mg 68071-3220-01 NuCare 100 tablets — AB FDA listed —
Lisinopril 40 mg 68788-7012-01 Preferred 100 tablets — AB FDA listed —
Lisinopril 40 mg 70518-1565-02 REMEDYREPACK 100 tablets — AB FDA listed —
Lisinopril 40 mg 70518-3166-00 REMEDYREPACK 30 tablets — AB FDA listed —
Lisinopril 40 mg 71335-0075-01 Bryant 30 tablets — AB Discontinued —
Lisinopril 40 mg 71610-0406-60 Aphena 90 tablets — AB FDA listed —
Lisinopril 40 mg 71610-0624-45 Aphena 45 tablets — AB FDA listed —
Lisinopril 40 mg 71610-0727-30 Aphena 30 tablets — AB FDA listed —
Lisinopril 40 mg 72865-0213-01 XLCare 100 tablets — AB FDA listed —
Lisinopril 40 mg 76420-0345-00 Asclemed 1000 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA208920 (ANDA)
Labeler code62135
First marketedMar 2021
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.

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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 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

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Adult Patients : Following oral administration of lisinopril tablets, peak serum concentrations of lisinopril occur within about 7 hours, although there was a trend to a small delay in time taken to reach peak serum concentrations in acute myocardial infarction patients. Food does not alter the bioavailability of lisinopril tablets. Declining serum concentrations exhibit a prolonged terminal phase, which does not contribute to drug accumulation.

This terminal phase probably represents saturable binding to ACE and is not proportional to dose. Upon multiple dosing, lisinopril exhibits an effective half-life of 12 hours. Lisinopril does not appear to be bound to other serum proteins.

Lisinopril does not undergo metabolism and is excreted unchanged entirely in the urine. Based on urinary recovery, the mean extent of absorption of lisinopril is approximately 25%, with large inter subject variability (6% to 60%) at all doses tested (5mg to 80 mg). The absolute bioavailability of lisinopril is reduced to 16% in patients with stable NYHA Class II-IV congestive heart failure, and the volume of distribution appears to be slightly smaller than that in normal subjects.

The oral bioavailability of lisinopril in patients with acute myocardial infarction is similar to that in healthy volunteers. Impaired renal function decreases elimination of lisinopril, which is excreted principally through the kidneys, but this decrease becomes clinically important only when the glomerular filtration rate is below 30 mL/min. Above this glomerular filtration rate, the elimination half-life is little changed.

With greater impairment, however, peak and trough lisinopril levels increase, time to peak concentration increases and time to attain steady state is prolonged [see Dosage and Administration (2.4) ] . Lisinopril can be removed by hemodialysis. Pediatric Patients: The pharmacokinetics of lisinopril were studied in 29 pediatric hypertensive patients between 6 years and 16 years with glomerular filtration rate > 30 mL/min/1.73 m 2 .

After doses of 0.1mg per kg to 0.2 mg per kg, steady state peak plasma concentrations of lisinopril occurred within 6 hours and the extent of absorption based on urinary recovery was about 28%. These values are similar to those obtained previously in adults. The typical value of lisinopril oral clearance (systemic clearance/absolute bioavailability) in a child weighing 30 kg is 10 L/h, which increases in proportion to renal function.

In a multicenter, open-label pharmacokinetic study of daily oral lisinopril in 22 pediatric hypertensive patients with stable kidney transplant (ages 7-17 years; estimated glomerular filtration rate > 30 mL/min/1.73 m 2 ), dose normalized exposures were in the range reported previously in children without a kidney transplant.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Hypertension Adult Patients: Administration of lisinopril tablets 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 tablets, 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 tablets are maintained during long-term therapy. Abrupt withdrawal of lisinopril tablets 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 tablets alone were compared to lisinopril tablets given concomitantly with indomethacin, the use of indomethacin was associated with a reduced effect, although the difference between the two regimens was not significant.

🔬 Clinical Studies 3 words ▾

14 CLINICAL STUDIES

🧪 Nonclinical Toxicology 3 words ▾

13 NONCLINICAL TOXICOLOGY

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of a tumorigenic effect when lisinopril was administered for 105 weeks to male and female rats at doses up to 90 mg per kg per day (about 56 or 9 times* the maximum recommended daily human dose, based on body weight and body surface area, respectively). There was no evidence of carcinogenicity when lisinopril was administered for 92 weeks to (male and female) mice at doses up to 135 mg per kg per day (about 84 times* the maximum recommended daily human dose).

This dose was 6.8 times the maximum human dose based on body surface area in mice. Lisinopril was not mutagenic in the Ames microbial mutagen test with or without metabolic activation. It was also negative in a forward mutation assay using Chinese hamster lung cells.

Lisinopril did not produce single strand DNA breaks in an in vitro alkaline elution rat hepatocyte assay. In addition, lisinopril did not produce increases in chromosomal aberrations in an in vitro test in Chinese hamster ovary cells or in an in vivo study in mouse bone marrow. There were no adverse effects on reproductive performance in male and female rats treated with up to 300 mg per kg per day of lisinopril.

This dose is 188 times and 30 times the maximum human dose when based on mg/kg and mg/m 2 , respectively. Studies in rats indicate that lisinopril crosses the blood brain barrier poorly. Multiple doses of lisinopril in rats do not result in accumulation in any tissues.

Milk of lactating rats contains radioactivity following administration of 14 C lisinopril. By whole body autoradiography, radioactivity was found in the placenta following administration of labeled drug to pregnant rats, but none was found in the fetuses. * Calculations assume a human weight of 50 kg and human body surface area of 1.62m 2

📄 Package Label / Principal Display Panel 147 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lisinopril Tablets, USP 2.5mg - NDC 62135-640-90- 90's Bottle Label Lisinopril Tablets, USP 2.5mg - NDC 62135-640-31- 300's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-90- 90's Bottle Label Lisinopril Tablets, USP 5mg - NDC 62135-641-31- 300's Bottle Label Lisinopril Tablets, USP 10mg - NDC 62135-642-90- 90's Bottle Label Lisinopril Tablets, USP10mg - NDC 62135-642-31- 300's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-90- 90's Bottle Label Lisinopril Tablets, USP 20mg - NDC 62135-643-31- 300's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-90- 90's Bottle Label Lisinopril Tablets, USP 30mg - NDC 62135-644-31- 300's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-90- 90's Bottle Label Lisinopril Tablets, USP 40mg - NDC 62135-645-31- 300's Bottle Label "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description" "Image Description"

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

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.
← 62135-0644-31 · Chartwell 62135-0646-90 · 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.