HomeNDC LookupIngredientsCaptopril › 27241-0162-10
Captopril 50 mg Tablet, 1,000-count — NDC 27241-0162-10 package photo

Captopril 50 mg Tablet, 1,000-count

by Ajanta Pharma USA Inc. · 1000 TABLET in 1 BOTTLE (27241-162-10)
NDC 27241-0162-10
🏷️ FDA NDC (as labeled) 27241-162-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.3254 NADAC Per package$325.40 / 1000 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.4929/unit — full pricing hub ↓
Also comes in: 100 tablets 27241-0162-01
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 →

🆔 Identity & classification

FDA NDC (as labeled) 27241-162-10
Product NDC 27241-162
11-digit billing NDC 27241016210
NCPDP billing unit EA — each (per item)
UNII 9G64RSX1XD
UPC 0327241160011, 0327241163012, 0327241161018, 0327241162015
Application # ANDA212809
SPL Set ID 1fbc9b28-ff10-4b17-a359-e12b4330747e
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 2019-12-13
Route ORAL
Dosage form TABLET
Substance CAPTOPRIL
GPI-14 36100010000315
GPI class Captopril
GCN Seq No 000381
GCN 01482
HICL code 000128
Ingredient (HICL) Captopril
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 CAPTOPRIL 50 MG TABLET
FDB brand name Captopril
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 27241-162-10 — 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 → 27241-0162-10. 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

LabelerAjanta Pharma USA Inc.
Application holderAJANTA PHARMA LTD
FDA applicationANDA212809 (ANDA)
Labeler code27241
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio168 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 CAPTOPRIL 50 MG TABLET Ingredient Captopril
📖 What it is MedlinePlus · NLM

Captopril is used alone or in combination with other medications to treat high blood pressure and heart failure. It is also used to improve survival and reduce the risk of heart failure after a heart attack in patients a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart). Captopril is also used to treat kidney disease (nephropathy) caused by diabetes in patients with type 1 diabetes and retinopathy (eye disease). Captopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It decreases certain chemicals...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Food in your stomach can reduce how much captopril your body actually absorbs by about 30 to 40 percent. Taking it on an empty stomach — about an hour before a meal — helps make su...
  • Why do I need to take captopril an hour before I eat?
  • Yes, a dry, persistent cough is a well-known side effect of ACE inhibitors like captopril. It happens because the drug affects certain natural substances in your airway. The cough...
  • I've developed a dry cough since starting captopril. Is that normal?
📖 Read our full Captopril guide →
2
Nutrient depletion considerations

Captopril may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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
ShapeRound
Imprint4;C
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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 DailyMedingredient 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 $0.325 $325.40 / 1000 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 $0.4929 $492.90 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Jan 2026 $1.260 $0.233
▼ Down 65% over the last 14 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
Captopril 50 mg 00143-1173-01 Hikma 100 tablets $0.310 AB Availability likely save 5%
Captopril 50 mg 11788-0137-01 AiPing 100 tablets $0.310 AB Availability likely save 5%
Captopril 50 mg 31722-0143-01 Camber 100 tablets $0.310 AB Availability likely save 5%
Captopril 50 mg 43547-0365-10 Solco 100 tablets $0.310 AB Availability likely save 5%
captopril 50 mg 58657-0737-01 Method 100 tablets $0.310 AB Availability likely save 5%
captopril 50 mg 69292-0526-01 AMICI 100 tablets $0.310 AB Availability likely save 5%
Captopril 50 mgthis 27241-0162-10 Ajanta 1000 tablets $0.325 AB FDA listed
Captopril 50 mg 51407-0602-01 Golden 100 tablets AB FDA listed
captopril 50 mg 58657-0937-01 Method 100 tablets AB FDA listed
captopril 50 mg 63629-3554-01 Bryant 90 tablets AB FDA listed
Captopril 50 mg 71335-2358-01 Bryant 90 tablets AB FDA listed
Captopril 50 mg 73190-0028-01 AvKARE 100 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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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.
Drug total (last 4 qtrs): 441 Rx · 22,162 units · $14,862 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 Captopril — the program that covers self-administered drugs. 6 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 Captopril. 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
$918.7K
Claims incl. refills
15K
Beneficiaries
10.7K
Spend / beneficiary
$85.97
Spend / claim
$61.43
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 Captopril — the ingredient across all brands.

Top reported reactions

Dyspnoea615
Hypertension536
Nausea508
Diarrhoea470
Pain454
Dizziness448
Asthenia425

Age at onset

Neonate31
Infant46
Child32
Adolescent11
Adult400
Elderly432

Reporter sex

9,625 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization4,863
Death1,570
Life-threatening917
Disabling378
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 470 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
27241-0162-01 100 TABLET in 1 BOTTLE (27241-162-01) $0.3098 / ea $30.98 2019-12-13 Active
27241-0162-10 You're viewing this 1000 TABLET in 1 BOTTLE (27241-162-10) $0.3254 / ea $325.44 2019-12-13 Active

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

Per ea, this pack runs about 5% above the cheapest pack (100-count, $0.3098 vs $0.3254 NADAC).

This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 27241-0162-10?
NDC 27241-0162-10 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 27241-0162-10 and NDC 27241-0162-01?
Both are Captopril 50 mg Tablet — the drug itself is identical. NDC 27241-0162-10 is the 1,000-count package, while NDC 27241-0162-01 is the 100 tablets package. Per-ea NADAC also differs: $0.3254 here vs $0.3098 for the 100 tablets pack.
What NDC number is used to bill for this package of Captopril 50 mg Tablet?
Bill NDC 27241-0162-10 — the 11-digit billing format is 27241016210. 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 35 words

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue captopril tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity

🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE Hypertension: Captopril tablets, USP, are indicated for the treatment of hypertension. In using captopril tablets, USP, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets, USP may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low.

In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets, USP are effective alone and in combination with other antihypertensive agents, especially thiazidetype diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.

Heart Failure: Captopril tablets, USP are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment. Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets, USP are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤ 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.

Diabetic Nephropathy: Captopril tablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets, USP decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis). In considering use of captopril tablets, USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.

In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS : Head and Neck Angioedema and Intestinal Angioedema ).

⏱️ Dosage and Administration ~3 min read

DOSAGE AND ADMINISTRATION Captopril tablets, USP should be taken one hour before meals. Dosage must be individualized. Hypertension: Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances.

If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting captopril. The initial dose of captopril tablets, USP is 25 mg twice daily or three times a day. If satisfactory reduction of blood pressure has not been achieved after one week or two weeks, the dose may be increased to 50 mg twice daily or three times a day.

Concomitant sodium restriction may be beneficial when captopril is used alone. The dose of captopril tablets, USP in hypertension usually does not exceed 50 mg three times a day. Therefore, if the blood pressure has not been satisfactorily controlled after one week to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added.

The diuretic dose may be increased at one-week to two-week intervals until its highest usual antihypertensive dose is reached. If captopril is being started in a patient already receiving a diuretic, captopril therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril as noted above. If further blood pressure reduction is required, the dose of captopril tablets, USP may be increased to 100 mg twice daily or three times a day and then, if necessary, to 150 mg twice daily or three times a day (while continuing the diuretic).

The usual dose range is 25 mg to 150 mg twice daily or three times a day. A maximum daily dose of 450 mg captopril tablets, USP should not be exceeded. For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and captopril tablets, USP dosage promptly initiated at 25 mg twice daily or three times a day, under close medical supervision.

When necessitated by the patient’s clinical condition, the daily dose of captopril tablets, USP may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of captopril is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated. Beta-blockers may also be used in conjunction with captopril therapy (see PRECAUTIONS: Drug Interactions ), but the effects of the two drugs are less than additive.

Heart Failure: Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 mg or 12.5 mg three times a day may minimize the magnitude or duration of the hypotensive effect (see WARNINGS: Hypotension ); for these patients, titration to the usual daily dosage can then occur within the next several days.

For most patients the usual initial daily dosage is 25 mg three times a day. After a dose of 50 mg three times a day is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 mg or 100 mg three times a day.

A maximum daily dose of 450 mg of captopril tablets should not be exceeded. Captopril should generally be used in conjunction with a diuretic and digitalis…

Contraindications 81 words

CONTRAINDICATIONS Captopril is contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril in patients with diabetes (see PRECAUTIONS , Drug Interactions ). Captopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).

Do not administer captopril within 36 hours of switching to or from sacubitril/valsartan, a nepriltsin inhibitor (see PRECAUTIONS , Drug Interactions ).

⚠️ Warnings ~3 min read

WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including captopril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril.

If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1,000 solution of epinephrine should be promptly instituted. Swelling confined to the face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuation of captopril; some cases required medical therapy.

(See PRECAUTIONS : Information for Patients and ADVERSE REACTIONS . ) Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS , Drug Interactions ). Intestinal Angioedema: Intestinal angioedema has been reported 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.

The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Anaphylactoid reactions during desensitization: Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.

In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid reactions during membrane exposure: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

Neutropenia/Agranulocytosis Neutropenia (< 1,000/mm 3 ) with myeloid hypoplasia has resulted from use of captopril. About half of the neutropenic patients developed systemic or oral cavity infections or other features of the syndrome of agranulocytosis. The risk of neutropenia is dependent on the clinical status of the patient: In clinical trials in patients with hypertension who have normal renal function (serum creatinine less than 1.6 mg/dL and no collagen vascular disease), neutropenia has been seen in one patient out of over 8,600 exposed.

In patients with some degree of renal failure (serum creatinine at least 1.6 mg/dL) but no collagen vascular disease, the risk of neutropenia in clinical trials was about 1 per 500, a frequency over 15 times that for uncomplicated hypertension. Daily doses of captopril were relatively high in these patients, particularly in view of their diminished renal function. In foreign marketing experience in patients with renal failure, use of allopurinol concomitantly with captopril has been associated with neutropenia but this association has not appeared in U.S. reports.

In patients with collagen vascular diseases (e.g., systemic lupus erythematosus, scleroderma) and impaired renal function, neutropenia occurred in 3.7 percent of patients in clinical trials. While none of the over 750 patients in formal clinical trials of heart failure developed neutropenia, it has occurred during the subsequent clinica…

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS Reported incidences are based on clinical trials involving approximately 7,000 patients. Renal : About one of 100 patients developed proteinuria (see WARNINGS ). Each of the following has been reported in approximately 1 to 2 of 1,000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency.

Hematologic : Neutropenia/agranulocytosis has occurred (see WARNINGS ). Cases of anemia, thrombocytopenia, and pancytopenia have been reported. Dermatologic : Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy.

It is usually maculopapular, and rarely urticarial. The rash is usually mild and disappears within a few days of dosage reduction, short-term treatment with an antihistaminic agent, and/or discontinuing therapy; remission may occur even if captopril is continued. Pruritus, without rash, occurs in about 2 of 100 patients.

Between 7 percent and 10 percent of patients with skin rash have shown an eosinophilia and/or positive ANA titers. A reversible associated pemphigoid-like lesion, and photosensitivity, have also been reported. Flushing or pallor has been reported in 2 to 5 of 1,000 patients.

Cardiovascular : Hypotension may occur; see WARNINGS and PRECAUTIONS [Drug Interactions] for discussion of hypotension with captopril therapy. Tachycardia, chest pain, and palpitations have each been observed in approximately 1 of 100 patients. Angina pectoris, myocardial infarction, Raynaud’s syndrome, and congestive heart failure have each occurred in 2 to 3 of 1,000 patients.

Dysgeusia : Approximately 2 to 4 (depending on renal status and dose) of 100 patients developed a diminution or loss of taste perception. Taste impairment is reversible and usually self-limited (2 months to 3 months) even with continued drug administration. Weight loss may be associated with the loss of taste.

Angioedema : Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been reported in approximately one in 1,000 patients. Angioedema involving the upper airways has caused fatal airway obstruction. (See WARNINGS: Head and Neck Angioedema , Intestinal Angioedema and PRECAUTIONS: Information for Patients . ) Cough: Cough has been reported in 0.5% to 2% of patients treated with captopril in clinical trials (see PRECAUTIONS: General , Cough).

The following have been reported in about 0.5 percent to 2 percent of patients but did not appear at increased frequency compared to placebo or other treatments used in controlled trials: gastric irritation, abdominal pain, nausea, vomiting, diarrhea, anorexia, constipation, aphthous ulcers, peptic ulcer, dizziness, headache, malaise, fatigue, insomnia, dry mouth, dyspnea, alopecia, paresthesias. Other clinical adverse effects reported since the drug was marketed are listed below by body system. In this setting, an incidence or causal relationship cannot be accurately determined.

Body as a whole : Anaphylactoid reactions (see WARNINGS: Anaphylactoid and possible related reactions and PRECAUTIONS: Hemodialysis ). General: Asthenia, gynecomastia . Cardiovascular: Cardiac arrest, cerebrovascular accident/insufficiency, rhythm disturbances, orthostatic hypotension, syncope .

Dermatologic : Bullous pemphigus, erythema multiforme (including Stevens-Johnson syndrome), exfoliative dermatitis. Gastrointestinal : Pancreatitis, glossitis, dyspepsia. Hematologic : Anemia, including aplastic and hemolytic.

Hepatobiliary : Jaundice, hepatitis, including rare cases of necrosis, cholestasis. Metabolic : Symptomatic hyponatremia. Musculoskeletal : Myalgia, myasthenia.

Nervous/Psychiatric : Ataxia, confusion, depression, nervousness, somnolence. Respiratory : Bronchospasm, eosinophilic pneumonitis, rhinitis. Special Senses : Blurred visio…

🆘 Overdosage 80 words

OVERDOSAGE Correction of hypotension would be of primary concern. Volume expansion with an intravenous infusion of normal saline is the treatment of choice for restoration of blood pressure. While captopril may be removed from the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the circulation of neonates or children.

Peritoneal dialysis is not effective for removing captopril; there is no information concerning exchange transfusion for removing captopril from the general circulation.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of captopril has not yet been fully elucidated. Its beneficial effects in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. However, there is no consistent correlation between renin levels and response to the drug.

Renin, an enzyme synthesized by the kidneys, is released into the circulation where it acts on a plasma globulin substrate to produce angiotensin I, a relatively inactive decapeptide. Angiotensin I is then converted by angiotensin converting enzyme (ACE) to angiotensin II, a potent endogenous vasoconstrictor substance. Angiotensin II also stimulates aldosterone secretion from the adrenal cortex, thereby contributing to sodium and fluid retention.

Captopril prevents the conversion of angiotensin I to angiotensin II by inhibition of ACE, a peptidyldipeptide carboxy hydrolase. This inhibition has been demonstrated in both healthy human subjects and in animals by showing that the elevation of blood pressure caused by exogenously administered angiotensin I was attenuated or abolished by captopril. In animal studies, captopril did not alter the pressor responses to a number of other agents, including angiotensin II and norepinephrine, indicating specificity of action.

ACE is identical to ''bradykininase'', and captopril may also interfere with the degradation of the vasodepressor peptide, bradykinin. Increased concentrations of bradykinin or prostaglandin E 2 may also have a role in the therapeutic effect of captopril. Inhibition of ACE results in decreased plasma angiotensin II and increased plasma renin activity (PRA), the latter resulting from loss of negative feedback on renin release caused by reduction in angiotensin II.

The reduction of angiotensin II leads to decreased aldosterone secretion, and, as a result, small increases in serum potassium may occur along with sodium and fluid loss. The antihypertensive effects persist for a longer period of time than does demonstrable inhibition of circulating ACE. It is not known whether the ACE present in vascular endothelium is inhibited longer than the ACE in circulating blood.

Pharmacokinetics After oral administration of therapeutic doses of captopril, rapid absorption occurs with peak blood levels at about one hour. The presence of food in the gastrointestinal tract reduces absorption by about 30 percent to 40 percent; captopril therefore should be given one hour before meals. Based on carbon-14 labeling, average minimal absorption is approximately 75 percent.

In a 24-hour period, over 95 percent of the absorbed dose is eliminated in the urine; 40 percent to 50 percent is unchanged drug; most of the remainder is the disulfide dimer of captopril and captopril-cysteine disulfide. Approximately 25 percent to 30 percent of the circulating drug is bound to plasma proteins. The apparent elimination half-life for total radioactivity in blood is probably less than 3 hours.

An accurate determination of half-life of unchanged captopril is not, at present, possible, but it is probably less than 2 hours. In patients with renal impairment, however, retention of captopril occurs (see DOSAGE AND ADMINISTRATION ). Pharmacodynamics Administration of captopril results in a reduction of peripheral arterial resistance in hypertensive patients with either no change, or an increase, in cardiac output.

There is an increase in renal blood flow following administration of captopril and glomerular filtration rate is usually unchanged. Reductions of blood pressure are usually maximal 60 minutes to 90 minutes after oral administration of an individual dose of captopril. The duration of effect is dose related.

The reduction in blood pressure may be progressive, so to achieve maximal therapeutic effects, several weeks of therapy may be required. The blood pressure lowering effects of captopril and thiazide-type diuretics are additive. In contrast, captopril and bet…

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Captopril tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of captopril, USP. The 12.5 mg tablets are white to off-white, oval shaped, flat beveled edged uncoated tablets having break line on both sides and one side debossed with “C” on one side of the break line and “1” on other side of the break line (bisect). They are available as follows: NDC 27241-160-01 bottles of 100 tablets with child-resistant closure NDC 27241-160-10 bottles of 1000 tablets The 25 mg tablets are white to off-white, round, flat beveled edged, uncoated tablets debossed with “2” over “C” one side and quadrisect score on the other side.

They are available as follows: NDC 27241-161-01 bottles of 100 tablets with child-resistant closure NDC 27241-161-10 bottles of 1000 tablets The 50 mg tablets are white to off-white, round, flat beveled edged, uncoated tablets debossed with “3” above the break line and “C” below the break line one side (bisect) and plain on the other side. They are available as follows: NDC 27241-162-01 bottles of 100 tablets with child-resistant closure NDC 27241-162-10 bottles of 1000 tablets The 100 mg tablets are white to off-white, round, flat beveled edged, uncoated tablets debossed with “4” above the break line and “C” below the break line on one side (bisect) and plain on the other side.

They are available as follows: NDC 27241-163-01 bottles of 100 tablets with child-resistant closure Bottles contain a desiccant-charcoal canister. All captopril tablets, USP are white to off-white and may exhibit a slight sulfurous odor. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep bottles tightly closed (protect from moisture). All trademarks are the properties of their respective owners. Product of Spain Manufactured by: Ajanta Pharma Limited, India Marketed by: Ajanta Pharma USA Inc.

Bridgewater, NJ 08807. Revised: 11/2025

📋 Description 111 words

DESCRIPTION Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl] -L-proline [MW 217.28] and has the following structure: Captopril USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 126 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate.

Captopril tablets, USP are available in potencies of 12.5 mg, 25 mg, 50 mg, and 100 mg as scored tablets for oral administration. Inactive ingredients: microcrystalline cellulose, lactose, crospovidone, colloidal silicon dioxide and stearic acid. captopril-structure

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