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Metoprolol Succinate 100 mg Tablet, Extended Release, 60-count — NDC 71205-0336-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Metoprolol Succinate 100 mg Tablet, Extended Release, 60-count — NDC 71205-336-60 (Billing 71205-0336-60)

by Proficient Rx LP · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 60 tablets of Metoprolol Succinate 100 mg Tablet, Extended Release from Proficient Rx LP, marketed since Feb 2018 and currently FDA-listed.

NDC 71205-0336-60
🏷️ FDA NDC (as labeled) 71205-336-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2385/unit — full pricing hub ↓
Product page 71205-0336-30 Also comes in: 30 tablets 71205-336-30 90 tablets 71205-336-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Metoprolol Succinate (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 29, 2026 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0355-2026
Class II · Jan 29, 2026 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0354-2026
Class II · Jan 29, 2026 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0357-2026
Class II · Jan 29, 2026 — Failed Dissolution Specifications (Teva Pharmaceuticals USA, Inc) · FDA recall D-0356-2026
Class II · Jun 24, 2025 — Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. (Granules Pharmaceuticals Inc.) · FDA recall D-0510-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-336-60
Product NDC 71205-336
11-digit billing NDC 71205033660
RxCUI 866412
UNII TH25PD4CCB
Application # ANDA204106
SPL Set ID 25d7926c-061f-4eb0-8d30-6397efeca16d
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-02-06
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METOPROLOL SUCCINATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 33200030057530
GPI class Metoprolol Succinate ER
GCN Seq No 016600
GCN 20742
HICL code 006323
Ingredient (HICL) Metoprolol Succinate
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 METOPROLOL SUCC ER 100 MG TAB
FDB brand name Metoprolol Succinate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016600
  • GCN: 20742
  • GPI-14 (Medi-Span): 33200030057530
  • HICL (First Databank): 006323
  • AHFS class code: 12:16.08.08
  • RxCUI (RxNorm): 866412
Why two NDCs? The FDA registers this code as 71205-336-60 — 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 → 71205-0336-60. 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 and calcium channel blockers, Beta blocking agents, selective
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 METOPROLOL SUCC ER 100 MG TAB Ingredient Metoprolol Succinate
📗 Our plain-language guide HelloPharmacist
  • It depends on which form you have. Metoprolol tartrate and Lopressor tablets treat high blood pressure and angina, and lower the risk of death after a heart attack. Metoprolol succ...
  • Take it exactly as prescribed. Tartrate tablets go with or right after a meal. Extended-release succinate tablets are taken once daily and should not be crushed or chewed. Ask your...
  • Please don't stop suddenly. Stopping abruptly can make angina worse and has led to heart attacks. Even if you only take it for blood pressure, your doctor will lower the dose gradu...
  • Tiredness, dizziness, a slow heartbeat, low blood pressure, diarrhea, itching or rash are the more common ones. Most were mild and temporary. Call your doctor if you faint, your he...
📖 Read our full Metoprolol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Metoprolol 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 $0.2385 $14.31 / 60 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
71205-0336-30 71205-336-30 Main listing 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2019-10-01 — Active
71205-0336-60 You're viewing this 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 2019-10-01 — Active
71205-0336-90 71205-336-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE 2019-10-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, extended release in 1 bottle.
How does this package differ from NDC 71205-0336-30?
Both are Metoprolol Succinate 100 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 60-count one, while NDC 71205-0336-30 is the 30 tablets package.
What NDC number is used to bill for this package of Metoprolol Succinate 100 mg Tablet, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metoprolol Succinate 100 mg 68001-0358-00 BluePoint 100 tablets $0.082 AB FDA listed —
Metoprolol succinate 100 mg 00904-6324-61 Major 1 tablet $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 27808-0304-01 Cranbury 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 31722-0591-01 Camber 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 42806-0726-01 Epic 100 tablets $0.085 AB Availability likely —
metoprolol succinate 100 mg 45963-0677-11 Actavis 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 50268-0542-15 AvPAK 1 tablet $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 50742-0617-01 Ingenus 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 55111-0468-01 Dr. 100 tablets $0.085 — Availability likely —
Metoprolol Succinate 100 mg 60687-0413-01 American 1 tablet $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 67877-0592-01 Ascend 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 68001-0470-00 BluePoint 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 68001-0502-00 BluePoint 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 68001-0686-00 BluePoint 100 tablets $0.085 AB Availability likely —
metoprolol succinate 100 mg 68382-0566-01 Zydus 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 70010-0782-01 Granules 100 tablets $0.085 AB Availability likely —
Metoprolol Succinate 100 mg 72516-0032-01 Oryza 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 72603-0144-01 Northstar 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 75907-0345-01 Dr. 100 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 82009-0115-05 Quallent 500 tablets $0.085 AB Availability likely —
Metoprolol succinate 100 mg 70436-0166-01 Slate 100 tablets $0.086 AB Availability likely —
Metoprolol Succinate 100 mg 75834-0292-00 Nivagen 1000 tablets $0.097 — Discontinued —
Toprol Xl 100 mg 70842-0112-02 Melinta 100 tablets $2.079 AB Availability likely —
Metoprolol succinate 100 mg 00615-7825-05 NCS 15 tablets — AB FDA listed —
Metoprolol succinate 100 mg 43063-0841-30 PD-Rx 30 tablets — AB FDA listed —
metoprolol succinate 100 mg 50090-5411-00 A-S 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 50090-5720-00 A-S 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 50090-5721-00 A-S 90 tablets — AB FDA listed —
Metoprolol succinate 100 mg 50090-6260-00 A-S 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 50090-7069-00 A-S 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 50090-7070-00 A-S 90 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 51407-0405-01 Golden 100 tablets — AB FDA listed —
metoprolol succinate 100 mg 51655-0193-26 Northwind 90 tablets — AB FDA listed —
Metoprolol succinate 100 mg 51655-0888-26 Northwind 90 tablets — AB FDA listed —
Metoprolol succinate 100 mg 53401-0014-30 Aphena 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 55154-4347-00 Cardinal 1 tablet — AB FDA listed —
Metoprolol succinate 100 mg 55154-7279-00 Cardinal 1 tablet — AB FDA listed —
metoprolol succinate 100 mg 60760-0663-90 St. 90 tablets — AB FDA listed —
Metoprolol succinate 100 mg 60760-0994-90 ST. 90 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 61919-0334-30 Direct_Rx 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 62207-0131-49 Granules 1000 tablets — — FDA listed —
Metoprolol succinate 100 mg 63187-0768-30 Proficient 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 63629-8865-01 Bryant 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 63629-9171-01 Bryant 500 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 63629-9172-01 Bryant 1000 tablets — AB FDA listed —
Metoprolol succinate 100 mg 68001-0119-00 BluePoint 100 tablets — AB FDA listed —
metoprolol succinate 100 mg 68071-2651-01 NuCare 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 68071-5282-01 NuCare 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 68788-8448-01 Preferred 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 69097-0408-02 Cipla 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 70518-2080-01 REMEDYREPACK 90 tablets — AB FDA listed —
metoprolol succinate 100 mg 70518-3122-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 70518-4190-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 70518-4407-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 70518-4456-00 REMEDYREPACK 90 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 70518-4533-00 REMEDYREPACK 30 tablets — AB FDA listed —
metoprolol succinate 100 mg 70771-1340-00 Zydus 1000 tablets — AB FDA listed —
Metoprolol Succinate 100 mgthis 71205-0336-60 Proficient 60 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 71205-0683-30 Proficient 30 tablets — AB FDA listed —
metoprolol succinate 100 mg 71205-0801-30 Proficient 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 71335-0167-01 Bryant 30 tablets — AB FDA listed —
metoprolol succinate 100 mg 71335-1951-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 71335-2945-01 Bryant 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 71335-9706-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 71610-0484-45 Aphena 45 tablets — AB Discontinued —
Metoprolol Succinate 100 mg 71610-0558-45 Aphena 45 tablets — AB FDA listed —
Metoprolol succinate 100 mg 71765-0007-01 Zhejiang 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 72162-1858-00 Bryant 1000 tablets — AB FDA listed —
Metoprolol succinate 100 mg 72516-0027-01 Oryza 100 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 82804-0279-90 Proficient 90 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 82868-0079-30 Northwind 30 tablets — AB FDA listed —
Metoprolol Succinate 100 mg 67046-1686-03 Coupler 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 71335-3167-01 Bryant 30 tablets — AB FDA listed —
Metoprolol succinate 100 mg 67296-2321-03 Redpharm 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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.

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

LabelerProficient Rx LP
Application holderNOVAST LABORATORIES LTD
FDA applicationANDA204106 (ANDA)
Labeler code71205
First marketedFeb 2018
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 184 words ▾

WARNING: ISCHEMIC HEART DISEASE: WARNING: ISCHEMIC HEART DISEASE See full prescribing information for complete boxed warning. Following abrupt cessation of therapy with beta-blocking agents, exacerbations of angina pectoris and myocardial infarction have occurred. Warn patients against interruption or discontinuation of therapy without the physician's advice.

( 5.1 ) Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate extended-release tablets, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, metoprolol succinate extended-release tablet administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken.

Warn patients against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue metoprolol succinate extended-release tablet therapy abruptly even in patients treated only for hypertension ( 5.1 ).

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets, USP are indicated for the treatment of: • Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

( 1.1 ) • Angina Pectoris. ( 1.2 ) • Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. ( 1.3 )

1.1Hypertension Metoprolol succinate extended-release tablets are 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 metoprolol.

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. Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents.

1.2Angina Pectoris Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.

1.3Heart Failure Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Administer once daily. Dosing of metoprolol succinate extended-release tablets, USP should be individualized. ( 2 ) • Heart Failure: Recommended starting dose is 12.5 mg or 25 mg doubled every two weeks to the highest dose tolerated or up to 200 mg.

( 2.3 ) • Hypertension: Usual initial dosage is 25 to 100 mg once daily. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. Dosages above 400 mg per day have not been studied.

( 2.1 ) • Angina Pectoris: Usual initial dosage is 100 mg once daily. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is an unacceptable bradycardia. Dosages above 400 mg per day have not been studied.

( 2.2 ) • Switching from immediate-release metoprolol to metoprolol succinate extended-release tablets: use the same total daily dose of metoprolol succinate extended-release tablets. ( 2 ) Metoprolol succinate extended-release tablets are an extended-release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release metoprolol to metoprolol succinate extended-release tablets, use the same total daily dose of metoprolol succinate extended-release tablets.

Individualize the dosage of metoprolol succinate extended- release tablets. Titration may be needed in some patients. Metoprolol succinate extended-release tablets are scored on both sides and can be divided; however, do not crush or chew the whole or half tablet.

2.1Hypertension Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy.

Dosages above 400 mg per day have not been studied. Pediatric Hypertensive Patients 6 Years of age: A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP); however, some other endpoints demonstrated effectiveness [see Use in Specific Populations (8.4) ] . If selected for treatment, the recommended starting dose of metoprolol succinate extended-release tablets is 1.0 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily.

Dosage should be adjusted according to blood pressure response. Doses above 2.0 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients [see Clinical Pharmacology (12.3) ]. Metoprolol succinate extended-release tablets are not recommended in pediatric patients < 6 years of age [see Use in Specific Populations (8.4) ] .

2.2Angina Pectoris Individualize the dosage of metoprolol succinate extended-release tablets. The usual initial dosage is 100 mg daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate.

Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 - 2 weeks [see Warnings and Precautions (5) ].

2.3Heart Failure Dosage must be individualized and closely monitored during up-titration. Prior to initiation of metoprolol succinate extended-release tablets, stabilize the dose of other heart failure drug therapy. The recommended starting dose of metoprolol succinate extended-release tablets is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure.

Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of metoprolol succinate extended-release tablets. Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate extended-release tablets. If patients exper… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 91 words ▾

3 DOSAGE FORMS AND STRENGTHS • Metoprolol succinate extended-release tablets, USP: 25 mg, 50 mg, 100 mg and 200 mg. ( 3 ) 25 mg tablets white, oval, biconvex, scored on both sides, film-coated tablet engraved with "N / 25". 50 mg tablets white, round, biconvex, scored on both sides, film-coated tablet engraved with "N / 50".

100 mg tablets white, round, biconvex, scored on both sides, film-coated tablet engraved with "N / 100". 200 mg tablets white, oval, biconvex, scored on both sides, film-coated tablet engraved with "N / 200".

⛔ Contraindications 92 words ▾

4 CONTRAINDICATIONS • Known hypersensitivity to product components. ( 4 ) • Severe bradycardia. ( 4 ) • Heart block greater than first degree.

( 4 ) • Cardiogenic shock. ( 4 ) • Decompensated cardiac failure. ( 4 ) • Sick sinus syndrome without a pacemaker.

( 4 ) Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) • Bronchospastic Disease: Avoid beta blockers. ( 5.3 ) • Pheochromocytoma: If required, first initiate therapy with an alpha blocker.

( 5.4 ) • Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery because it has been associated with bradycardia, hypotension, stroke and death. Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5.5 , 6.1 ) • Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia.

( 5.6 ) • Patients with Hepatic Impairment: ( 5.7 ) • Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. ( 5.8 ) • Anaphylactic Reactions: Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. ( 5.9 ) • Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency.

( 5.10 ) • Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly. ( 5.11 )

5.1Ischemic Heart Disease Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered metoprolol succinate extended-release tablets, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 - 2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly reinstate metoprolol succinate extended-release tablets, and take measures appropriate for the management of unstable angina.

Warn patients not to interrupt therapy without their physician's advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing metoprolol succinate extended-release tablets in patients treated only for hypertension.

5.2Heart Failure Worsening cardiac failure may occur during up-titration of metoprolol succinate extended-release tablets. If such symptoms occur, increase diuretics and restore clinical stability before advancing the dose of metoprolol succinate extended-release tablets [see Dosage and Administration (2) ]. It may be necessary to lower the dose of metoprolol succinate extended-release tablets or temporarily discontinue it.

Such episodes do not preclude subsequent successful titration of metoprolol succinate extended-release tablets.

5.3Bronchospastic Disease PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta 1 cardio-selectivity, however, metoprolol succinate extended-release tablets may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta 1 -selectivity is not absolute, use the lowest possible dose of metoprolol succinate extended-release tablets.

Bronchodilators, including beta 2 -agonists, should be readily available or administered concomitantly [see Dosage and Administration (2) ].

5.4Pheochromocytoma If metoprolol succinate extended-release tablets are used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

5.5Major Surgery Avoid initiation of a high-dose regimen of extended-release metoprolol in patients undergoing non-cardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke and death. Chronically a… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS • Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals LLC Toll-Free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following adverse reactions are described elsewhere in labeling: • Worsening angina or myocardial infarction [see Warnings and Precautions (5) ]. • Worsening heart failure [see Warnings and Precautions (5) ]. • Worsening AV block [see Contraindications (4) ].

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension and Angina: Most adverse reactions have been mild and transient.

The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea, shortness of breath, bradycardia, and rash. Heart Failure: In the MERIT-HF study comparing metoprolol succinate extended-release tablets in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of metoprolol succinate extended-release tablets patients discontinued for adverse reactions vs. 12.2% of placebo patients.

The table below lists adverse reactions in the MERIT-HF study that occurred at an incidence of 1% in the metoprolol succinate extended-release tablets group and greater than placebo by more than 0.5%, regardless of the assessment of causality. Adverse Reactions Occurring in the MERIT-HF Study at an Incidence ≥1% in the metoprolol succinate extended-release tablets Group and Greater Than Placebo by More Than 0.5% Metoprolol succinate extended-release tablet group; n=1990 % of patients Placebo; n=2001 % of patients Dizziness/vertigo 1.8

1.0Bradycardia 1.5

0.4Accident and/or injury 1.4

0.8Post-operative Adverse Events: In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, metoprolol succinate extended-release tablets 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol succinate extended-release tablets use was associated with a higher incidence of bradycardia (6.6% vs. 2.4%; HR, 2.74; 95% CI 2.19, 3.43), hypotension (15% vs.

9.7%; HR 1.55; 95% CI 1.37, 1.74), stroke (1.0% vs. 0.5%; HR 2.17; 95% CI 1.26, 3.74) and death (3.1% vs. 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.

6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of metoprolol succinate extended-release tablets or immediate-release metoprolol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain and hypotension.

Respiratory: Wheezing (bronchospasm), dyspnea. Central Nervous System: Confusion, short-term memory loss, headache, somnolence, nightmares, insomnia, anxiety/nervousness, hallucinations, paresthesia. Gastrointestinal: Nausea, dry mouth, constipation, flatulence, heartburn, hepatitis, vomiting.

Hypersensitive Reactions: Pruritus. Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie's disease, sweating, photosensitivity, taste di… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS • Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. ( 7.1 ) • CYP2D6 Inhibitors are likely to increase metoprolol concentration. ( 7.2 ) • Concomitant use of glycosides, clonidine, and diltiazem and verapamil with beta-blockers can increase the risk of bradycardia.

( 7.3 ) • Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. ( 7.3 )

7.1Catecholamine Depleting Drugs Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with metoprolol succinate extended-release tablets plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

7.2CYP2D6 Inhibitors Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone are likely to increase metoprolol concentration. In healthy subjects with CYP2D6 extensive metabolizer phenotype, coadministration of quinidine 100 mg and immediate-release metoprolol 200 mg tripled the concentration of S-metoprolol and doubled the metoprolol elimination half-life. In four patients with cardiovascular disease, coadministration of propafenone 150 mg t.i.d. with immediate-release metoprolol 50 mg t.i.d. resulted in two- to five-fold increases in the steady-state concentration of metoprolol.

These increases in plasma concentration would decrease the cardioselectivity of metoprolol.

7.3Digitalis, Clonidine, and Calcium Channel Blockers Digitalis glycosides, clonidine, diltiazem and verapamil slow atrioventricular conduction and decrease heart rate. Concomitant use with beta blockers can increase the risk of bradycardia. If clonidine and a beta blocker, such as metoprolol are coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because beta-blockers may exacerbate the rebound hypertension that can follow the withdrawal of clonidine.

If replacing clonidine by beta-blocker therapy, delay the introduction of beta-blockers for several days after clonidine administration has stopped [see Warnings and Precautions (5.11) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use this drug during pregnancy only if clearly needed. ( 8.1 ) • Nursing Mothers: Consider possible infant exposure.

( 8.3 ) • Pediatrics: Safety and effectiveness have not been established in patients < 6 years of age. ( 8.4 ) • Geriatrics: No notable difference in efficacy or safety vs. younger patients. ( 8.5 ) • Hepatic Impairment: Consider initiating metoprolol succinate extended-release tablet therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events.

( 8.6 )

8.1Pregnancy Pregnancy Category C Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratogenicity.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.

8.3Nursing Mothers Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Consider possible infant exposure when metoprolol succinate extended-release tablets are administered to a nursing woman.

8.4Pediatric Use One hundred forty-four hypertensive pediatric patients aged 6 to 16 years were randomized to placebo or to one of three dose levels of metoprolol succinate extended-release tablets. (0.2, 1.0 or 2.0 mg/kg once daily) and followed for 4 weeks. The study did not meet its primary endpoint (dose response for reduction in SBP).

Some pre-specified secondary endpoints demonstrated effectiveness including: • Dose-response for reduction in DBP, • 1 mg/kg vs. placebo for change in SBP, and • 2 mg/kg vs. placebo for change in SBP and DBP. The mean placebo corrected reductions in SBP ranged from 3 to 6 mmHg, and DBP from 1 to 5 mmHg. Mean reduction in heart rate ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals [see Dosage and Administration (2.1) ] .

No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of metoprolol succinate extended-release tablets have not been established in patients < 6 years of age.

8.5Geriatric Use Clinical studies of metoprolol succinate extended-release tablets in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. Of the 1,990 patients with heart failure randomized to metoprolol succinate extended-release tablets in the MERIT-HF trial, 50% (990) were 65 years of age and older and 12% (238) were 75 years of age and older.

There were no notable differences in efficacy or the rate of adverse reactions between older and younger patients. In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6Hepatic Impairment No studies have been performed with metoprolol succinate extended-release tablets in patients with hepatic impairment. Because metoprolol succinate extended-release tablets is metabolized by the liver, metoprolol blood levels are likely to increase substantially with poor hepatic function. Therefore, initiate therapy at doses lower than those recommended for a given indication; and increase doses gr… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 100 words ▾

8.1Pregnancy Pregnancy Category C Metoprolol tartrate has been shown to increase post-implantation loss and decrease neonatal survival in rats at doses up to 22 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratogenicity.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.

🧒 Pediatric Use 180 words ▾

8.4Pediatric Use One hundred forty-four hypertensive pediatric patients aged 6 to 16 years were randomized to placebo or to one of three dose levels of metoprolol succinate extended-release tablets. (0.2, 1.0 or 2.0 mg/kg once daily) and followed for 4 weeks. The study did not meet its primary endpoint (dose response for reduction in SBP).

Some pre-specified secondary endpoints demonstrated effectiveness including: • Dose-response for reduction in DBP, • 1 mg/kg vs. placebo for change in SBP, and • 2 mg/kg vs. placebo for change in SBP and DBP. The mean placebo corrected reductions in SBP ranged from 3 to 6 mmHg, and DBP from 1 to 5 mmHg. Mean reduction in heart rate ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals [see Dosage and Administration (2.1) ] .

No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. Safety and effectiveness of metoprolol succinate extended-release tablets have not been established in patients < 6 years of age.

🧓 Geriatric Use 134 words ▾

8.5Geriatric Use Clinical studies of metoprolol succinate extended-release tablets in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. Of the 1,990 patients with heart failure randomized to metoprolol succinate extended-release tablets in the MERIT-HF trial, 50% (990) were 65 years of age and older and 12% (238) were 75 years of age and older.

There were no notable differences in efficacy or the rate of adverse reactions between older and younger patients. In general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 201 words ▾

10 OVERDOSAGE Signs and Symptoms - Overdosage of metoprolol succinate extended-release tablets may lead to severe bradycardia, hypotension, and cardiogenic shock. Clinical presentation can also include: atrioventricular block, heart failure, bronchospasm, hypoxia, impairment of consciousness/coma, nausea and vomiting. Treatment – Consider treating the patient with intensive care.

Patients with myocardial infarction or heart failure may be prone to significant hemodynamic instability. Seek consultation with a regional poison control center and a medical toxicologist as needed. Beta-blocker overdose may result in significant resistance to resuscitation with adrenergic agents, including beta-agonists.

On the basis of the pharmacologic actions of metoprolol, employ the following measures. There is very limited experience with the use of hemodialysis to remove metoprolol, however metoprolol is not highly protein bound. Bradycardia: Evaluate the need for atropine, adrenergic-stimulating drugs or pacemaker to treat bradycardia and conduction disorders.

Hypotension: Treat underlying bradycardia. Consider intravenous vasopressor infusion, such as dopamine or norepinephrine. Heart failure and shock: May be treated when appropriate with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenergic drugs such as dobutamine, with 1 receptor agonistic drugs added in presence of vasodilation.

Bronchospasm: Can usually be reversed by bronchodilators.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity. Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

12.2Pharmacodynamics Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -adrenoreceptors, chiefly located in the bronchial and vascular musculature.

Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade. Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction. The relative beta 1 -selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta 2 -mediated vasodilating effects of epinephrine.

This contrasts with the effect of nonselective beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, metoprolol reduces FEV 1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta 1 -receptor blocking doses. The relationship between plasma metoprolol levels and reduction in exercise heart rate is independent of the pharmaceutical formulation.

Using an E max model, the maximum effect is a 30% reduction in exercise heart rate, which is attributed to beta 1 -blockade. Beta 1 -blocking effects in the range of 30-80% of the maximal effect (approximately 8-23% reduction in exercise heart rate) correspond to metoprolol plasma concentrations from 30-540 nmol/L. The relative beta 1 -selectivity of metoprolol diminishes and blockade of beta 2 -adrenoceptors increases at plasma concentration above 300 nmol/L.

Although beta-adrenergic receptor blockade is useful in the treatment of angina, hypertension, and heart failure there are situations in which sympathetic stimulation is vital. In patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. In the presence of AV block, beta-blockade may prevent the necessary facilitating effect of sympathetic activity on conduction.

Beta 2 -adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients. In other studies, treatment with metoprolol succinate extended-release tablets produced an improvement in left ventricular ejection fraction. Metoprolol succinate extended-release tablets was also shown to delay the increase in left ventricular end-systolic and end-diastolic volumes after 6 months of treatment.

12.3Pharmacokinetics Adults: In man, absorption of metoprolol is rapid and complete. Plasma levels following oral administration of conventional metoprolol tablets, however, approximate 50% of levels following intravenous administration, indicating about 50% first-pass metabolism. Metoprolol crosses the blood-brain barrier and has been reported in the CSF in a concentration 78% of the simultan… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 78 words ▾

12.1Mechanism of Action Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity. Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

📦 How Supplied / Storage and Handling 74 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets containing metoprolol succinat, USP equivalent to the indicated weight of metoprolol tartrate, USP, are white, biconvex, film-coated, and scored on both sides. Shape Engraving Bottle of 30 NDC 71205 Bottle of 60 NDC 71205 Bottle of 90 NDC 71205 100 mg Round N/100 336-30 336-60 336-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

📋 Description 181 words ▾

11 DESCRIPTION Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets.

Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt).

Its structural formula is: Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: sugar spheres, povidone, ethyl cellulose, polyethylene glycol, hydroxypropyl cellulose, triethyl citrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, polydextrose, hypromellose, and triacetin. image-01

💬 Information for Patients 147 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients to take metoprolol succinate extended-release tablets regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue metoprolol succinate extended-release tablets without consulting the physician.

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with metoprolol succinate extended-release tablets has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking metoprolol succinate extended-release tablets. Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. image-03

🍼 Nursing Mothers 49 words ▾

8.3Nursing Mothers Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Consider possible infant exposure when metoprolol succinate extended-release tablets are administered to a nursing woman.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Adults: In man, absorption of metoprolol is rapid and complete. Plasma levels following oral administration of conventional metoprolol tablets, however, approximate 50% of levels following intravenous administration, indicating about 50% first-pass metabolism. Metoprolol crosses the blood-brain barrier and has been reported in the CSF in a concentration 78% of the simultaneous plasma concentration.

Plasma levels achieved are highly variable after oral administration. Only a small fraction of the drug (about 12%) is bound to human serum albumin. Metoprolol is a racemic mixture of R- and S- enantiomers, and is primarily metabolized by CYP2D6.

When administered orally, it exhibits stereoselective metabolism that is dependent on oxidation phenotype. Elimination is mainly by biotransformation in the liver, and the plasma half-life ranges from approximately 3 to 7 hours. Less than 5% of an oral dose of metoprolol is recovered unchanged in the urine; the rest is excreted by the kidneys as metabolites that appear to have no beta-blocking activity.

Following intravenous administration of metoprolol, the urinary recovery of unchanged drug is approximately 10%. The systemic availability and half-life of metoprolol in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. Consequently, no reduction in metoprolol succinate dosage is usually needed in patients with chronic renal failure.

Metoprolol is metabolized predominantly by CYP2D6, an enzyme that is absent in about 8% of Caucasians (poor metabolizers) and about 2% of most other populations. CYP2D6 can be inhibited by a number of drugs. Poor metabolizers and extensive metabolizers who concomitantly use CYP2D6 inhibiting drugs will have increased (several-fold) metoprolol blood levels, decreasing metoprolol's cardioselectivity [see Drug Interactions (7.2) ] .

In comparison to conventional metoprolol, the plasma metoprolol levels following administration of metoprolol succinate extended-release tablets are characterized by lower peaks, longer time to peak and significantly lower peak to trough variation. The peak plasma levels following once-daily administration of metoprolol succinate extended-release tablets average one-fourth to one-half the peak plasma levels obtained following a corresponding dose of conventional metoprolol, administered once daily or in divided doses.

At steady state the average bioavailability of metoprolol following administration of metoprolol succinate extended-release tablets, across the dosage range of 50 to 400 mg once daily, was 77% relative to the corresponding single or divided doses of conventional metoprolol. Nevertheless, over the 24-hour dosing interval, 1 -blockade is comparable and dose-related [see Clinical Pharmacology (12) ] . The bioavailability of metoprolol shows a dose-related, although not directly proportional, increase with dose and is not significantly affected by food following metoprolol succinate extended-release tablets administration.

Pediatrics: The pharmacokinetic profile of metoprolol succinate extended-release tablets was studied in 120 pediatric hypertensive patients (6-17 years of age) receiving doses ranging from 12.5 to 200 mg once daily. The pharmacokinetics of metoprolol were similar to those described previously in adults. Age, gender, race, and ideal body weight had no significant effects on metoprolol pharmacokinetics.

Metoprolol apparent oral clearance (CL/F) increased linearly with body weight. Metoprolol pharmacokinetics have not been investigated in patients < 6 years of age.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -adrenoreceptors, chiefly located in the bronchial and vascular musculature.

Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade. Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction. The relative beta 1 -selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta 2 -mediated vasodilating effects of epinephrine.

This contrasts with the effect of nonselective beta-blockers, which completely reverse the vasodilating effects of epinephrine. (2) In asthmatic patients, metoprolol reduces FEV 1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta 1 -receptor blocking doses. The relationship between plasma metoprolol levels and reduction in exercise heart rate is independent of the pharmaceutical formulation.

Using an E max model, the maximum effect is a 30% reduction in exercise heart rate, which is attributed to beta 1 -blockade. Beta 1 -blocking effects in the range of 30-80% of the maximal effect (approximately 8-23% reduction in exercise heart rate) correspond to metoprolol plasma concentrations from 30-540 nmol/L. The relative beta 1 -selectivity of metoprolol diminishes and blockade of beta 2 -adrenoceptors increases at plasma concentration above 300 nmol/L.

Although beta-adrenergic receptor blockade is useful in the treatment of angina, hypertension, and heart failure there are situations in which sympathetic stimulation is vital. In patients with severely damaged hearts, adequate ventricular function may depend on sympathetic drive. In the presence of AV block, beta-blockade may prevent the necessary facilitating effect of sympathetic activity on conduction.

Beta 2 -adrenergic blockade results in passive bronchial constriction by interfering with endogenous adrenergic bronchodilator activity in patients subject to bronchospasm and may also interfere with exogenous bronchodilators in such patients. In other studies, treatment with metoprolol succinate extended-release tablets produced an improvement in left ventricular ejection fraction. Metoprolol succinate extended-release tablets was also shown to delay the increase in left ventricular end-systolic and end-diastolic volumes after 6 months of treatment.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES In five controlled studies in normal healthy subjects, the same daily doses of metoprolol succinate extended-release tablets and immediate-release metoprolol were compared in terms of the extent and duration of beta 1 - blockade produced. Both formulations were given in a dose range equivalent to 100-400 mg of immediate-release metoprolol per day. In these studies, metoprolol succinate extended-release tablets was administered once a day and immediate-release metoprolol was administered once to four times a day.

A sixth controlled study compared the beta 1 -blocking effects of a 50 mg daily dose of the two formulations. In each study, beta 1 -blockade was expressed as the percent change from baseline in exercise heart rate following standardized submaximal exercise tolerance tests at steady state. Metoprolol succinate extended-release tablets administered once a day, and immediate-release metoprolol administered once to four times a day, provided comparable total beta 1 -blockade over 24 hours (area under the beta 1 -blockade versus time curve) in the dose range 100-400 mg.

At a dosage of 50 mg once daily, metoprolol succinate extended-release tablets produced significantly higher total beta 1 -blockade over 24 hours than immediate-release metoprolol. For metoprolol succinate extended-release tablets, the percent reduction in exercise heart rate was relatively stable throughout the entire dosage interval and the level of beta 1 -blockade increased with increasing doses from 50 to 300 mg daily. The effects at peak/trough (i.e., at 24-hours post-dosing) were: 14/9, 16/10, 24/14, 27/22 and 27/20% reduction in exercise heart rate for doses of 50, 100, 200, 300 and 400 mg metoprolol succinate extended-release tablets once a day, respectively.

In contrast to metoprolol succinate extended-release tablets, immediate-release metoprolol given at a dose of 50-100 mg once a day produced a significantly larger peak effect on exercise tachycardia, but the effect was not evident at 24 hours. To match the peak to trough ratio obtained with metoprolol succinate extended-release tablets over the dosing range of 200 to 400 mg, a t.i.d. to q.i.d. divided dosing regimen was required for immediate-release metoprolol. A controlled cross-over study in heart failure patients compared the plasma concentrations and beta 1 -blocking effects of 50 mg immediate-release metoprolol administered t.i.d., 100 mg and 200 mg metoprolol succinate extended-release tablets once daily.

A 50 mg dose of immediate-release metoprolol t.i.d. produced a peak plasma level of metoprolol similar to the peak level observed with 200 mg of metoprolol succinate extended-release tablets. A 200 mg dose of metoprolol succinate extended-release tablets produced a larger effect on suppression of exercise-induced and Holter-monitored heart rate over 24 hours compared to 50 mg t.i.d. of immediate-release metoprolol. In a double-blind study, 1092 patients with mild-to-moderate hypertension were randomized to once daily metoprolol succinate extended-release tablets (25, 100, or 400 mg), felodipine extended-release tablets, the combination, or placebo.

After 9 weeks, metoprolol succinate extended-release tablets alone decreased sitting blood pressure by 6-8/4-7 mmHg (placebo-corrected change from baseline) at 24 hours post-dose. The combination of metoprolol succinate extended-release tablets with felodipine extended-release tablets has greater effects on blood pressure. In controlled clinical studies, an immediate-release dosage form of metoprolol was an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics at dosages of 100-450 mg daily.

Metoprolol succinate extended-release tablets, in dosages of 100 to 400 mg once daily, produces similar 1 -blockade as conventional metoprolol tablets administered two to four times daily. In addition, metoprolol succinate extended-release tablets administered at a dose of 50 mg once d… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term studies in animals have been conducted to evaluate the carcinogenic potential of metoprolol tartrate. In 2-year studies in rats at three oral dosage levels of up to 800 mg/kg/day (41 times, on a mg/m 2 basis, the daily dose of 200 mg for a 60-kg patient), there was no increase in the development of spontaneously occurring benign or malignant neoplasms of any type. The only histologic changes that appeared to be drug related were an increased incidence of generally mild focal accumulation of foamy macrophages in pulmonary alveoli and a slight increase in biliary hyperplasia.

In a 21-month study in Swiss albino mice at three oral dosage levels of up to 750 mg/kg/day (18 times, on a mg/m 2 basis, the daily dose of 200 mg for a 60-kg patient), benign lung tumors (small adenomas) occurred more frequently in female mice receiving the highest dose than in untreated control animals. There was no increase in malignant or total (benign plus malignant) lung tumors, nor in the overall incidence of tumors or malignant tumors. This 21-month study was repeated in CD-1 mice, and no statistically or biologically significant differences were observed between treated and control mice of either sex for any type of tumor.

All genotoxicity tests performed on metoprolol tartrate (a dominant lethal study in mice, chromosome studies in somatic cells, a Salmonella /mammalian-microsome mutagenicity test, and a nucleus anomaly test in somatic interphase nuclei) and metoprolol succinate (a Salmonella /mammalian-microsome mutagenicity test) were negative. No evidence of impaired fertility due to metoprolol tartrate was observed in a study performed in rats at doses up to 22 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient.

📚 References 37 words ▾

15 REFERENCES 1. Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet . 2008; 371:1839-47.

📄 Package Label / Principal Display Panel 18 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-100mg NDC 71205-336-90 90 tablets Metoprolol succinate extended-release tablets, USP 100 mg* Rx only 71205-336-90

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 Metoprolol Succinate — the program that covers self-administered drugs. 23 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 Metoprolol Succinate. 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
$119.69M
Claims incl. refills
8.6M
Beneficiaries
6.5M
Spend / beneficiary
$18.38
Spend / claim
$13.98
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
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.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (71205-0336-30), 90 tablets (71205-0336-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP 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.
← 71205-0335-20 · Proficient 71205-0338-30 · Proficient →
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.