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TENORMIN Atenolol 50 mg Tablet, 90-count — NDC 52427-0430-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TENORMIN Atenolol 50 mg Tablet, 90-count — NDC 52427-430-90 (Billing 52427-0430-90)

by Almatica Pharma LLC · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of TENORMIN Atenolol 50 mg Tablet from Almatica Pharma LLC, no longer marketed (first marketed Apr 2015), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026. It is this product's only package size.

NDC 52427-0430-90
🏷️ FDA NDC (as labeled) 52427-430-90 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

NDC database record

One package, one record: these facts belong to NDC 52427-430-90 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
52427 labeler · 430 product · 90 package
Package marketed since
Apr 15, 2015
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Billing quantity
90 EA per package
Barcode (UPC)
0352427431906, 0352427430909, 0352427429903
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52427-430-90
Product NDC 52427-430
11-digit billing NDC 52427043090
NCPDP billing unit EA — each (per item)
RxCUI 150750, 152414, 197379, 197380, 197381, 201322
UNII 50VV3VW0TI
UPC 0352427431906, 0352427430909, 0352427429903
Application # NDA018240
SPL Set ID 746db603-a6e1-4dc3-c2d8-92314419098c
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2015-04-15
Marketing end 2026-09-30
Route ORAL
Dosage form TABLET
Substance ATENOLOL
TE code (Orange Book) AB · RLD · RS

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

GPI-14 33200020000305
GPI class Tenormin
GCN Seq No 005139
GCN 20661
HICL code 002104
Ingredient (HICL) Atenolol
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7C
Therapeutic class — specific (HIC3) Beta-Adrenergic Blocking Agents
AHFS code 12:16.08.08
AHFS class Selective Beta-Adrenergic Blocking Agent
FDB label name TENORMIN 50 MG TABLET
FDB brand name Tenormin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005139
  • GCN: 20661
  • GPI-14 (Medi-Span): 33200020000305
  • HICL (First Databank): 002104
  • AHFS class code: 12:16.08.08
  • RxCUI (RxNorm): 150750
Why two NDCs? The FDA registers this code as 52427-430-90 — 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 → 52427-0430-90. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, selective, Beta blocking agents and calcium channel blockers
How it works Adrenergic beta-Antagonists
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 TENORMIN 50 MG TABLET Ingredient Atenolol
📗 Our plain-language guide HelloPharmacist
  • It treats high blood pressure and helps manage long-term angina. It is also used in people who are stable after a definite or suspected heart attack to lower the risk of death from...
  • Atenolol tablets are swallowed by mouth, usually once a day. Take it as your prescriber and the label direct. Your doctor may adjust the dose based on how you respond.
  • Please don't stop it suddenly. Stopping abruptly can make angina worse and has led to heart attacks and dangerous heart rhythms. Talk to your doctor first so they can guide you.
  • Tiredness, dizziness, cold hands and feet, and a slower heartbeat are the more common ones. Most are mild and pass. Call your doctor for fainting, wheezing, swelling, worsening bre...
📖 Read our full Atenolol guide →
1
Nutrient depletion considerations

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

🧪 Full Atenolol 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $13.07 $1,176.40 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52427-0430-90 You're viewing this Main listing 90 TABLET in 1 BOTTLE 2015-04-15 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atenolol 50 mg 00093-0752-01 Teva 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 00378-0231-01 Mylan 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 29300-0411-01 Unichem 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 51079-0684-20 Mylan 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 64980-0438-01 Rising 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 65862-0169-01 Aurobindo 100 tablets $0.024 — Availability likely —
Atenolol 50 mg 68382-0023-01 Zydus 100 tablets $0.024 AB Availability likely —
Atenolol 50 mg 83980-0023-01 Ipca 100 tablets $0.024 AB Availability likely —
Tenormin 50 mg 24979-0245-07 Upsher-Smith 90 tablets $12.782 AB Availability likely —
Atenolol 50 mg 00615-8373-05 NCS 15 tablets — AB FDA listed —
Atenolol 50 mg 42708-0012-30 QPharma, 30 tablets — AB FDA listed —
Atenolol 50 mg 42708-0143-30 QPharma, 30 tablets — AB FDA listed —
Atenolol 50 mg 42708-0162-30 QPharma 30 tablets — AB FDA listed —
Atenolol 50 mg 43063-0765-30 PD-Rx 30 tablets — AB FDA listed —
Atenolol 50 mg 43353-0834-30 Aphena 30 tablets — AB FDA listed —
Atenolol 50 mg 48433-0005-20 Safecor 100 tablets — AB FDA listed —
Atenolol 50 mg 50090-0442-00 A-S 100 tablets — AB FDA listed —
Atenolol 50 mg 50090-5363-00 A-S 100 tablets — AB FDA listed —
Atenolol 50 mg 50090-5367-00 A-S 100 tablets — AB FDA listed —
Atenolol 50 mg 50090-5741-00 A-S 100 tablets — AB FDA listed —
Atenolol 50 mg 50090-6779-00 A-S 90 tablets — AB FDA listed —
Atenolol 50 mg 50090-7561-00 A-S 90 tablets — AB FDA listed —
Atenolol 50 mg 50090-7847-00 A-S 90 tablets — AB FDA listed —
Atenolol 50 mg 51655-0928-26 Northwind 90 tablets — AB FDA listed —
Tenormin 50 mgthis 52427-0430-90 Almatica 90 tablets — AB Discontinued —
Atenolol 50 mg 55154-5455-00 Cardinal 10 tablets — AB FDA listed —
Atenolol 50 mg 60429-0025-10 Golden 1000 tablets — AB FDA listed —
Atenolol 50 mg 60760-0643-30 St. 30 tablets — AB FDA listed —
Atenolol 50 mg 63187-0710-30 Proficient 30 tablets — AB FDA listed —
Atenolol 50 mg 65841-0023-01 Zydus 100 tablets — AB FDA listed —
Atenolol 50 mg 67046-0843-03 Coupler 30 tablets — AB FDA listed —
Atenolol 29300-411 50 mg 68071-3694-01 NuCare 100 tablets — AB FDA listed —
Atenolol 50 mg 68071-3830-01 NuCare 120 tablets — AB FDA listed —
Atenolol 50 mg 68071-4527-01 NuCare 120 tablets — AB FDA listed —
Atenolol 50 mg 68071-4553-01 NuCare 100 tablets — AB FDA listed —
Atenolol 50 mg 68788-7616-01 Preferred 100 tablets — AB FDA listed —
Atenolol 50 mg 68788-8834-01 Preferred 100 tablets — AB FDA listed —
Atenolol 50 mg 70518-3036-00 REMEDYREPACK 30 tablets — AB FDA listed —
Atenolol 50 mg 71205-0229-30 Proficient 30 tablets — AB FDA listed —
Atenolol 50 mg 71205-0496-30 Proficient 30 tablets — AB FDA listed —
Atenolol 50 mg 71335-0912-01 Bryant 30 tablets — AB FDA listed —
Atenolol 50 mg 71335-0954-01 Bryant 30 tablets — AB FDA listed —
Atenolol 50 mg 71610-0861-30 Aphena 30 tablets — AB FDA listed —
Atenolol 50 mg 72162-2325-00 Bryant 1000 tablets — AB FDA listed —
Atenolol 50 mg 72189-0135-30 direct 30 tablets — AB FDA listed —
Atenolol 50 mg 72789-0144-30 PD-Rx 30 tablets — AB FDA listed —
Atenolol 50 mg 83008-0052-30 Quality 30 tablets — AB FDA listed —
Atenolol 50 mg 87063-0178-01 ASCLEMED 100 tablets — AB FDA listed —
Atenolol 50 mg 55154-0283-00 Cardinal 10 tablets — AB FDA listed —
Atenolol 50 mg 60760-0925-30 St. 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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

LabelerAlmatica Pharma LLC
Application holderTWI PHARMACEUTICALS INC
FDA applicationNDA018240 (NDA)
Labeler code52427
First marketedApr 2015
Product typeHuman Prescription Drug
Portfolio26 products on file

More NDCs from Almatica Pharma LLC labeler code 52427

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Hypertension TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol.

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

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

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

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

Angina Pectoris Due to Coronary Atherosclerosis TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows.

(See DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and WARNINGS . ) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Hypertension The initial dose of TENORMIN is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to TENORMIN 100 mg given as one tablet a day.

Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit. TENORMIN may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa. Angina Pectoris The initial dose of TENORMIN is 50 mg given as one tablet a day.

If an optimal response is not achieved within one week, the dosage should be increased to TENORMIN 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect.

The maximum early effect on exercise tolerance occurs with doses of 50 mg to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg. Acute Myocardial Infarction In patients with definite or suspected acute myocardial infarction, treatment with TENORMIN I.V. Injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established.

Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg TENORMIN over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. TENORMIN I.V.

Injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of TENORMIN I.V. Injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used.

These admixtures are stable for 48 hours if they are not used immediately. In patients who tolerate the full intravenous dose (10 mg), TENORMIN Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, TENORMIN can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital.

If bradycardia or hypotension requiring treatment or any other untoward effects occur, TENORMIN should be discontinued. (See full prescribing information prior to initiating therapy with TENORMIN Tablets.) Data from other beta-blocker trials suggest that if there is any question concerning the use of I.V. beta-blocker or clinical estimate that there is a contraindication, the I.V. beta-blocker may be eliminated and patients fulfilling the safety criteria may be given TENORMIN Tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the I.V. dosing is excluded).

Although the demonstration of efficacy of TENORMIN is based entirely on data from the first seven postinfarction days, data from other beta-blocker trials suggest that treatment with beta-blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications. TENORMIN is an additional treatment to standard coronary care unit therapy. Elderly Patients or Patients with Renal Impairment TENORMIN is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction s… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 44 words ▾

CONTRAINDICATIONS TENORMIN is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. (See WARNINGS . ) TENORMIN is contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients with acute myocardial infarction, cardiac failure which is not promptly and effectively controlled by 80 mg of intravenous furosemide or equivalent therapy is a contraindication to beta-blocker treatment. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure.

At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, TENORMIN should be withdrawn. (See DOSAGE AND ADMINISTRATION .) Cessation of Therapy with TENORMIN Patients with coronary artery disease, who are being treated with TENORMIN, should be advised against abrupt discontinuation of therapy.

Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of TENORMIN is planned, the patients should be carefully observed and advised to limit physical activity to a minimum.

If the angina worsens or acute coronary insufficiency develops, it is recommended that TENORMIN be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TENORMIN therapy abruptly even in patients treated only for hypertension. (See DOSAGE AND ADMINISTRATION . ) Concomitant Use of Calcium Channel Blockers Bradycardia and heart block can occur and the left ventricular end diastolic pressure can rise when beta-blockers are administered with verapamil or diltiazem.

Patients with pre-existing conduction abnormalities or left ventricular dysfunction are particularly susceptible. (See PRECAUTIONS . ) Bronchospastic Diseases PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 selectivity, however, TENORMIN may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment.

Since beta 1 selectivity is not absolute, the lowest possible dose of TENORMIN should be used with therapy initiated at 50 mg and a beta 2 -stimulating agent (bronchodilator) should be made available. If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism.

Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom TENORMIN therapy is to be withdrawn should be monitored closely. (See DOSAGE AND ADMINISTRATION .) Untreated Pheochromocytoma TEN… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Most adverse effects have been mild and transient. The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (US studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both TENORMIN and placebo-treated patients than when these reactions were volunteered.

Where frequency of adverse effects of TENORMIN and placebo is similar, causal relationship to TENORMIN is uncertain. Volunteered (US Studies) Total − Volunteered and Elicited (Foreign + US Studies) Atenolol (n=164) % Placebo (n=206) % Atenolol (n=399) % Placebo (n=407) % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM/ NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2

0.2 Light-headedness 1 0 3

0.7Tiredness 0.6 0.5 26 13 Fatigue 3 1 6 5 Lethargy 1 0 3

0.7Drowsiness 0.6 0 2

0.5Depression 0.6 0.5 12 9 Dreaming 0 0 3 1 GASTROINTESTINAL Diarrhea 2 0 3 2 Nausea 4 1 3 1 RESPIRATORY (See WARNINGS ) Wheeziness 0 0 3 3 Dyspnea 0.6 1 6 4 Acute Myocardial Infarction In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta-blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol.

Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table. In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration: Conventional Therapy Plus Atenolol (n=244) Conventional Therapy Alone (n=233) Bradycardia 43 (18%) 24 (10%) Hypotension 60 (25%) 34 (15%) Bronchospasm 3 (1.2%) 2 (0.9%) Heart Failure 46 (19%) 56 (24%) Heart Block 11 (4.5%) 10 (4.3%) BBB + Major Axis Deviation 16 (6.6%) 28 (12%) Supraventricular Tachycardia 28 (11.5%) 45 (19%) Atrial Fibrillation 12 (5%) 29 (11%) Atrial Flutter 4 (1.6%) 7 (3%) Ventricular Tachycardia 39 (16%) 52 (22%) Cardiac Reinfarction 0 (0%) 6 (2.6%) Total Cardiac Arrests 4 (1.6%) 16 (6.9%) Nonfatal Cardiac Arrests 4 (1.6%) 12 (5.1%) Deaths 7 (2.9%) 16 (6.9%) Cardiogenic Shock 1 (0.4%) 4 (1.7%) Development of Ventricular Septal Defect 0 (0%) 2 (0.9%) Development of Mitral Regurgitation 0 (0%) 2 (0.9%) Renal Failure 1 (0.4%) 0 (0%) Pulmonary Emboli 3 (1.2%) 0 (0%) In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive TENORMIN treatment, the dosage of intravenous and subsequent oral TENORMIN was either discontinued or reduced for the following reasons: Reasons for Reduced Dosage I.V.

Atenolol Reduced Dose (<5 mg) Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg. Oral Partial Dose Hypotension/Bradycardia 105 (1.3%) 1168 (14.5%) Cardiogenic Shock 4 (.04%) 35 (.44%) Reinfarction 0 (0%) 5 (.06%) Cardiac Arrest 5 (.06%) 28 (.34%) Heart Block (> first degree) 5 (.06%) 143 (1.7%) Cardiac Failure 1 (.01%) 233 (2.9%) Arrhythmias 3 (.04%) 22 (.27%) Bronchospasm 1 (.01%) 50 (.62%) During postmarketing experience with TENORMIN, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie's disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth.

TENORMIN, like other beta-blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Rayna… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

Drug Interactions Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with TENORMIN plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension. Calcium channel blockers may also have an additive effect when given with TENORMIN (see WARNINGS ).

Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers.

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta-blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped.

Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta-blockers. Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta-blockers in the acute myocardial infarction setting.

While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.

Concomitant use can increase the risk of bradycardia.

🤰 Pregnancy 22 words ▾

Pregnancy See WARNINGS - Pregnancy and Fetal Injury . *Based on the maximum dose of 100 mg/day in a 50 kg patient.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 213 words ▾

Geriatric Use Hypertension and Angina Pectoris Due to Coronary Atherosclerosis: Clinical studies of TENORMIN did not include sufficient number of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Acute Myocardial Infarction: Of the 8,037 patients with suspected acute myocardial infarction randomized to TENORMIN in the ISIS-1 trial (See CLINICAL PHARMACOLOGY ), 33% (2,644) were 65 years of age and older. It was not possible to identify significant differences in efficacy and safety between older and younger patients; however, elderly patients with systolic blood pressure < 120 mmHg seemed less likely to benefit (See INDICATIONS AND USAGE ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Overdosage with TENORMIN has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following TENORMIN overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia.

Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in TENORMIN overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. TENORMIN can be removed from the general circulation by hemodialysis.

Other treatment modalities should be employed at the physician's discretion and may include: BRADYCARDIA: Atropine intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated.

HEART BLOCK (SECOND OR THIRD DEGREE): Isoproterenol or transvenous cardiac pacemaker. CARDIAC FAILURE: Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful.

HYPOTENSION: Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously. BRONCHOSPASM: A beta 2 stimulant such as isoproterenol or terbutaline and/or aminophylline.

HYPOGLYCEMIA: Intravenous glucose. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY TENORMIN is a beta 1 -selective (cardioselective) beta-adrenergic receptor blocking agent without membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. This preferential effect is not absolute, however, and at higher doses, TENORMIN inhibits beta 2 -adrenoreceptors, chiefly located in the bronchial and vascular musculature. Pharmacokinetics and Metabolism In man, absorption of an oral dose is rapid and consistent but incomplete.

Approximately 50% of an oral dose is absorbed from the gastrointestinal tract, the remainder being excreted unchanged in the feces. Peak blood levels are reached between two (2) and four (4) hours after ingestion. Unlike propranolol or metoprolol, but like nadolol, TENORMIN undergoes little or no metabolism by the liver, and the absorbed portion is eliminated primarily by renal excretion.

Over 85% of an intravenous dose is excreted in urine within 24 hours compared with approximately 50% for an oral dose. TENORMIN also differs from propranolol in that only a small amount (6% to 16%) is bound to proteins in the plasma. This kinetic profile results in relatively consistent plasma drug levels with about a 4-fold interpatient variation.

The elimination half-life of oral TENORMIN is approximately 6 to 7 hours, and there is no alteration of the kinetic profile of the drug by chronic administration. Following intravenous administration, peak plasma levels are reached within 5 minutes. Declines from peak levels are rapid (5- to 10-fold) during the first 7 hours; thereafter, plasma levels decay with a half-life similar to that of orally administered drug.

Following oral doses of 50 mg or 100 mg, both beta-blocking and antihypertensive effects persist for at least 24 hours. When renal function is impaired, elimination of TENORMIN is closely related to the glomerular filtration rate; significant accumulation occurs when the creatinine clearance falls below 35 mL/min/1.73m 2 . (See DOSAGE AND ADMINISTRATION . ) Pharmacodynamics In standard animal or human pharmacological tests, beta-adrenoreceptor blocking activity of TENORMIN has been demonstrated by: (1) reduction in resting and exercise heart rate and cardiac output, (2) reduction of systolic and diastolic blood pressure at rest and on exercise, (3) inhibition of isoproterenol induced tachycardia, and (4) reduction in reflex orthostatic tachycardia.

A significant beta-blocking effect of TENORMIN, as measured by reduction of exercise tachycardia, is apparent within one hour following oral administration of a single dose. This effect is maximal at about 2 to 4 hours, and persists for at least 24 hours. Maximum reduction in exercise tachycardia occurs within 5 minutes of an intravenous dose.

For both orally and intravenously administered drug, the duration of action is dose related and also bears a linear relationship to the logarithm of plasma TENORMIN concentration. The effect on exercise tachycardia of a single 10 mg intravenous dose is largely dissipated by 12 hours, whereas beta-blocking activity of single oral doses of 50 mg and 100 mg is still evident beyond 24 hours following administration. However, as has been shown for all beta-blocking agents, the antihypertensive effect does not appear to be related to plasma level.

In normal subjects, the beta 1 selectivity of TENORMIN has been shown by its reduced ability to reverse the beta 2 -mediated vasodilating effect of isoproterenol as compared to equivalent beta-blocking doses of propranolol. In asthmatic patients, a dose of TENORMIN producing a greater effect on resting heart rate than propranolol resulted in much less increase in airway resistance. In a placebo controlled comparison of approximately equipotent oral doses of several beta-blockers, TENORMIN produced a significantly smaller decrease of FEV 1 than nonselective beta-blockers such as propranolol and, unlike those agents, did not inhibit bronchodilation in response to isoproterenol.

Consistent with… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 122 words ▾

HOW SUPPLIED TENORMIN Tablets Tablets of 25 mg atenolol are round, flat, uncoated white tablets identified with "T" debossed on one side and 107 debossed on the other side, supplied in bottles of 90 tablets (NDC 52427-429-90). Tablets of 50 mg atenolol are round, flat, uncoated white tablets identified with "TENORMIN" debossed on one side and 105 debossed on the other side, bisected, supplied in bottles of 90 tablets (NDC 52427-430-90). Tablets of 100 mg atenolol are round, flat, uncoated white tablets identified with "TENORMIN" debossed on one side and 101 debossed on the other side, supplied in bottles of 90 tablets (NDC 52427-431-90).

Store at controlled room temperature, 20°C to 25°C (68°F to 77°F) [see USP]. Dispense in well-closed, light-resistant containers.

📋 Description 108 words ▾

DESCRIPTION TENORMIN ® (atenolol), a synthetic, beta 1 -selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are: Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23.

It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

💬 Information for Patients 32 words ▾

Information for Patients Inform patients or caregivers that there is a risk of hypoglycemia when TENORMIN is given to patients who are fasting or who are vomiting. Monitor for symptoms of hypoglycemia.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Patients already on a beta-blocker must be evaluated carefully before TENORMIN is administered. Initial and subsequent TENORMIN dosages can be adjusted downward depending on clinical observations including pulse and blood pressure. TENORMIN may aggravate peripheral arterial circulatory disorders.

Impaired Renal Function The drug should be used with caution in patients with impaired renal function. (See DOSAGE AND ADMINISTRATION .) *Based on the maximum dose of 100 mg/day in a 50 kg patient. Information for Patients Inform patients or caregivers that there is a risk of hypoglycemia when TENORMIN is given to patients who are fasting or who are vomiting.

Monitor for symptoms of hypoglycemia. Drug Interactions Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with TENORMIN plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

Calcium channel blockers may also have an additive effect when given with TENORMIN (see WARNINGS ). Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers.

Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers. Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta-blocker should be withdrawn several days before the gradual withdrawal of clonidine.

If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped. Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta-blockers. Information on concurrent usage of atenolol and aspirin is limited.

Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta-blockers in the acute myocardial infarction setting. While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction.

Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Carcinogenesis, Mutagenesis, Impairment of Fertility Two long-term (maximum dosing duration of 18 or 24 months) rat studies and one long-term (maximum dosing duration of 18 months) mouse study, each employing dose levels as high as 300 mg/kg/day or 150 times the maximum recommended human antihypertensive dose, * did not indicate a carcinogenic potential of atenolol.

A third (24 month) rat study, employing doses of 500 mg/kg/day and 1,500 mg/kg/day (250 and 750 times the maximum recommended human antihypertensive dose * ) resulted in increased incidences of benign adrenal medullary tumors in males and females, mammary fibroadenomas in females, and anterior pituitary adenomas and thyroid parafollicular cell carcinomas in males. No evidence of a mutagenic potential of atenolol was uncovered in the dominant lethal test (mouse), in vivo cytogenetics test (Chinese hamster) or Ames test ( S typhimurium ).

Fertility of male or female rats (evaluated at dose levels as high as 200 mg/kg/day or 100 times the maximum recommended human dose * ) was unaffected by atenolol administration. Animal Toxicology Chronic studies employing oral atenolol performed in animals have revealed the occurrence of vacuolation of epithelial cells of Brunne… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 104 words ▾

Nursing Mothers Atenolol is excreted in human breast milk at a ratio of 1.5 to 6.8 when compared to the concentration in plasma. Caution should be exercised when TENORMIN is administered to a nursing woman. Clinically significant bradycardia has been reported in breastfed infants.

Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects. Neonates born to mothers who are receiving TENORMIN at parturition or breastfeeding may be at risk for hypoglycemia and bradycardia. Caution should be exercised when TENORMIN is administered during pregnancy or to a woman who is breastfeeding (See WARNINGS, Pregnancy and Fetal Injury ).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 168 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Two long-term (maximum dosing duration of 18 or 24 months) rat studies and one long-term (maximum dosing duration of 18 months) mouse study, each employing dose levels as high as 300 mg/kg/day or 150 times the maximum recommended human antihypertensive dose, * did not indicate a carcinogenic potential of atenolol. A third (24 month) rat study, employing doses of 500 mg/kg/day and 1,500 mg/kg/day (250 and 750 times the maximum recommended human antihypertensive dose * ) resulted in increased incidences of benign adrenal medullary tumors in males and females, mammary fibroadenomas in females, and anterior pituitary adenomas and thyroid parafollicular cell carcinomas in males.

No evidence of a mutagenic potential of atenolol was uncovered in the dominant lethal test (mouse), in vivo cytogenetics test (Chinese hamster) or Ames test ( S typhimurium ). Fertility of male or female rats (evaluated at dose levels as high as 200 mg/kg/day or 100 times the maximum recommended human dose * ) was unaffected by atenolol administration.

📄 Package Label / Principal Display Panel 56 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 25 mg NDC 52427-429-90 Rx Only TENORMIN ® (atenolol) 25 mg tablets 90 Tablets

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 50 mg NDC 52427-430-90 Rx Only TENORMIN ® (atenolol) 50 mg tablets 90 Tablets

PACKAGE/LABEL PRINCIPAL DISPLAY - 100 mg NDC 52427-431-90 Rx Only TENORMIN ® (atenolol) 100 mg tablets 90 Tablets

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 Tenormin — the program that covers self-administered drugs. 2 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 Tenormin. 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
$495.1K
Claims incl. refills
487
Beneficiaries
333
Spend / beneficiary
$1,486.69
Spend / claim
$1,016.57
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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Almatica Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 52427-0288-01 · Almatica 52427-0431-90 · Almatica →
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.