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Metoprolol Tartrate 25 mg Tablet, Film Coated, 120-count

by Aphena Pharma Solutions - Tennessee, LLC · 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-70)

NDC 71610-0556-70

🏷️ FDA NDC (as labeled) 71610-556-70 billing pads the product segment with a zero

This package

Contains120-count Pack sizes8 compare ↓

Also priced by: Part D plans $0.0707/unit — full pricing hub ↓

Also comes in: 30 tablets 71610-0556-30 45 tablets 71610-0556-45 60 tablets 71610-0556-53 90 tablets 71610-0556-60 180 tablets 71610-0556-80 270 tablets 71610-0556-92 540 tablets 71610-0556-98

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

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

⚠️

Other active recalls for Metoprolol Tartrate (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · May 6, 2024 — Presence of Foreign Substance: metal in tablet (Rubicon Research Private Limited) · FDA recall D-0517-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71610-556-70

Product NDC 71610-556

11-digit billing NDC 71610055670

NCPDP billing unit EA — each (per item)

RxCUI 866511, 866514, 866924

UNII W5S57Y3A5L

Application # ANDA076704

SPL Set ID ea141b60-b08e-4f0f-9f29-cd765f4d7ca6

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 2004-01-16

Route ORAL

Dosage form TABLET, FILM COATED

Substance METOPROLOL TARTRATE

GPI-14 33200030100305

GPI class Metoprolol Tartrate

GCN Seq No 050631

GCN 17734

HICL code 002102

Ingredient (HICL) Metoprolol Tartrate

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 TARTRATE 25 MG TAB

FDB brand name Metoprolol Tartrate

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71610-556-70 — 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 → 71610-0556-70. 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.

🏭 Manufacturer & labeler

LabelerAphena Pharma Solutions - Tennessee, LLC

Application holderMYLAN PHARMACEUTICALS INC

FDA applicationANDA076704 (ANDA)

Labeler code71610

First marketedJan 2004

Product typeHuman Prescription Drug

Portfolio790 products on file

🔎 All NDCs from Aphena Pharma Solutions - Tennessee, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METOPROLOL TARTRATE 25 MG TAB Ingredient Metoprolol Tartrate

📖 What it is MedlinePlus · NLM

Metoprolol is used to treat high blood pressure, angina (chest pain) and heart failure. Metoprolol also is used to improve survival after a heart attack . Metoprolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

That depends on why you were prescribed it. Metoprolol is a beta-blocker, which means it slows your heart rate and reduces the workload on your heart. Depending on your formulation...
What exactly is metoprolol supposed to do for me?
Please don't stop suddenly — this is one of the most important things to know about this drug. Stopping metoprolol abruptly, especially if you have any heart disease, can cause you...
Can I stop taking metoprolol if I feel fine or if it makes me tired?

📖 Read our full Metoprolol guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

COENZYME Q10 Insufficient Evidence

🧪 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.

💊 What it looks like

Color white / pink / blue

ShapeRound

ImprintM;47

Size1 mm

ScoringScored — splits in 2

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

UNII 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII VH2XOU12IE
Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per each	Per 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	$0.0707	$8.48 / 120 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Metoprolol Tartrate 25 mg 00378-0018-01	Mylan	100 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 51079-0255-20	Mylan	1 tablet	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 52817-0250-00	TRUPHARMA	1000 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 52817-0360-00	TruPharma	1000 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 57237-0100-01	Rising	100 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 62584-0265-01	American	1 tablet	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 65862-0062-01	Aurobindo	100 tablets	$0.016	—	Availability likely	—
Metoprolol Tartrate 25 mg 72888-0004-00	Advagen	1000 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 72888-0208-00	Advagen	1000 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 76282-0794-01	Exelan	100 tablets	$0.016	AB	Availability likely	—
Metoprolol Tartrate 25 mg 00615-8421-05	NCS	15 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 42708-0110-60	QPharma	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 43063-0927-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 46708-0290-10	Alembic	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 48433-0073-20	Safecor	1 tablet	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-2207-00	A-S	180 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-5070-00	A-S	90 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7362-00	A-S	180 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7363-00	A-S	90 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7567-00	A-S	180 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7568-00	A-S	90 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7738-00	A-S	180 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 50090-7739-00	A-S	90 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 51407-0109-01	Golden	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 51655-0534-25	Northwind	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 53401-0011-53	Aphena	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 53401-0015-53	Aphena	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 55154-4752-00	Cardinal	1 tablet	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 55154-5356-00	Cardinal	1 tablet	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 55289-0382-14	PD-Rx	14 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 62332-0112-30	Alembic	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 63187-0600-30	Proficient	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 67046-1561-03	Coupler	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 67046-1592-03	Coupler	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 67296-1903-03	RedPharm	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 67296-2216-01	Redpharm	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 68071-3723-03	NuCare	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 68071-5236-01	NuCare	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 68788-8509-01	Preferred	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 68788-8840-01	Preferred	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-2615-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-3291-00	REMEDYREPACK	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-3506-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-3950-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-4308-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70882-0132-60	Cambridge	60 tablets	—	AB	Discontinued	—
Metoprolol Tartrate 25 mg 71205-0003-30	Proficient	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-0192-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-0743-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-1142-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-2789-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-9745-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71610-0137-60	Aphena	90 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71610-0184-53	Aphena	60 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mgthis 71610-0556-70	Aphena	120 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 72189-0640-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 76420-0054-20	Asclemed	20 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 82868-0037-20	Northwind	20 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 87063-0184-01	ASCLEMED	100 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 71335-1600-01	Bryant	30 tablets	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 55154-0279-00	Cardinal	1 tablet	—	AB	FDA listed	—
Metoprolol Tartrate 25 mg 70518-4714-00	REMEDYREPACK	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

🏛️

2004

On the market since

Jan 2004

📍

2026

Currently FDA-listed

22 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Metoprolol Tartrate — the program that covers self-administered drugs. 13 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Metoprolol Tartrate. 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

$27.2M

Claims incl. refills

3.6M

Beneficiaries

2.6M

Spend / beneficiary

$10.52

Spend / claim

$7.50

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for METOPROLOL TARTRATE — the ingredient across all brands.

Top reported reactions

Fatigue17,503

Dyspnoea15,655

Nausea15,032

Diarrhoea15,029

Dizziness12,868

Death10,767

Asthenia10,471

Reporter sex

Serious outcomes

Hospitalization108,722

Death30,933

Life-threatening12,202

Disabling6,077

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71610-0556-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-30)	2021-05-20	Active
71610-0556-45	45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-45)	2022-03-08	Active
71610-0556-53	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-53)	2021-05-20	Active
71610-0556-60	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-60)	2021-05-19	Active
71610-0556-70 You're viewing this	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-70)	2021-05-19	Active
71610-0556-80	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-80)	2021-05-19	Active
71610-0556-92	270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-92)	2021-05-19	Active
71610-0556-98	540 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-98)	2021-05-19	Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0556-70?

NDC 71610-0556-70 is a 120-count package — 120 tablet, film coated in 1 bottle, plastic.

What is the difference between NDC 71610-0556-70 and NDC 71610-0556-30?

Both are Metoprolol Tartrate 25 mg Tablet, Film Coated — the drug itself is identical. NDC 71610-0556-70 is the 120-count package, while NDC 71610-0556-30 is the 30 tablets package.

What NDC number is used to bill for this package of Metoprolol Tartrate 25 mg Tablet, Film Coated?

Bill NDC 71610-0556-70 — the 11-digit billing format is 71610055670. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ 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 FDA registers it as 71610-556-70, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71610-0556-70, written without dashes as 71610055670. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71610-0556-70, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0556) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (70) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Aphena Pharma Solutions - Tennessee, LLC. 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 7 other package presentations of this same product, including 30 tablets (71610-0556-30), 45 tablets (71610-0556-45), 60 tablets (71610-0556-53). 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?

Aphena Pharma Solutions - Tennessee, 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 110 words ▾

INDICATIONS AND USAGE Hypertension Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. Angina Pectoris Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.

Myocardial Infarction Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS and WARNINGS ).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Hypertension Individualize the dosage of metoprolol tartrate tablets. Metoprolol tartrate tablets should be taken with or immediately following meals. The usual initial dosage of metoprolol tartrate tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic.

Increase the dosage 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 one week of therapy. The effective dosage range of metoprolol tartrate tablets is 100 mg to 450 mg per day.

Dosages above 450 mg per day have not been studied. While once daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day.

Beta 1 selectivity diminishes as the dose of metoprolol is increased. Angina Pectoris The dosage of metoprolol tartrate tablets should be individualized. Metoprolol tartrate tablets should be taken with or immediately following meals.

The usual initial dosage of metoprolol tartrate tablets is 100 mg daily, given in two divided doses. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of metoprolol tartrate tablets is 100 mg to 400 mg per day.

Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1 to 2 weeks (see WARNINGS ). Myocardial Infarction Early Treatment During the early phase of definite or suspected acute myocardial infarction, initiate treatment with metoprolol tartrate tablets as soon as possible after the patient’s arrival in the hospital.

Such treatment should be initiated in a coronary care or similar unit immediately after the patient’s hemodynamic condition has stabilized. Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; give the injections at approximately 2 minute intervals. During the intravenous administration of metoprolol, monitor blood pressure, heart rate, and electrocardiogram.

In patients who tolerate the full intravenous dose (15 mg), initiate metoprolol tartrate tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily (see Late Treatment below). Start patients who appear not to tolerate the full intravenous dose on metoprolol tartrate tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows.

In patients with severe intolerance, discontinue metoprolol tartrate tablets (see WARNINGS ). Late Treatment Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months.

Although the efficacy of metoprolol beyond 3 months has not been conclusively established, data from studies with other beta-blockers suggest that treatment should be continued for 1 to 3 years. Special Populations Pediatric Patients No pediatric studies have been performed. The safety and efficacy of metoprolol in pediatric patients have not been established.

Renal Impairment No dose adjustment of metoprolol tartrate tablets is required in pa…

⛔ Contraindications 98 words ▾

CONTRAINDICATIONS Hypertension and Angina Metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur). Sick-sinus syndrome.

Severe peripheral arterial circulatory disorders. Myocardial Infarction Metoprolol is contraindicated in patients with a heart rate < 45 beats/min; second- and third-degree heart block; significant first-degree heart block (P-R interval ≥ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate to severe cardiac failure (see WARNINGS ).

⚠️ Warnings ~2 min read ▾

WARNINGS Heart Failure Beta-blockers, like metoprolol, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of metoprolol or to discontinue it.

Ischemic Heart Disease Do not abruptly discontinue metoprolol therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered metoprolol, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1 to 2 weeks and the patient should be carefully monitored.

If angina markedly worsens or acute coronary insufficiency develops, metoprolol administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned 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 therapy abruptly even in patients treated only for hypertension.

Use During 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. Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of metoprolol. Patients with first-degree atrioventricular block sinus node dysfunction or conduction disorders may be at increased risk.

Monitor heart rate and rhythm in patients receiving metoprolol. If severe bradycardia develops, reduce or stop metoprolol. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease, should, in general, not receive beta-blockers, including metoprolol.

Because of its relative beta 1 selectivity, however, metoprolol 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 and consider administering metoprolol in smaller doses 3 times daily, instead of larger doses 2 times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION ). Bronchodilators, including beta 2 agonists, should be readily available or administered concomitantly.

Diabetes and Hypoglycemia Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Pheochromocytoma If metoprolol is 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.

Thyrotoxicosis Metoprolol may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Hypertension and Angina Most adverse effects have been mild and transient. Central Nervous System Tiredness and dizziness have occurred in about 10 of 100 patients. Depression has been reported in about 5 of 100 patients.

Mental confusion and short-term memory loss have been reported. Headache, nightmares, and insomnia have also been reported. Cardiovascular Shortness of breath and bradycardia have occurred in approximately 3 of 100 patients.

Cold extremities; arterial insufficiency, usually of the Raynaud type; palpitations; congestive heart failure; peripheral edema; and hypotension have been reported in about 1 of 100 patients. Gangrene in patients with preexisting severe peripheral circulatory disorders has also been reported very rarely (see CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS ). Respiratory Wheezing (bronchospasm) and dyspnea have been reported in about 1 of 100 patients (see WARNINGS ).

Rhinitis has also been reported. Gastrointestinal Diarrhea has occurred in about 5 of 100 patients. Nausea, dry mouth, gastric pain, constipation, flatulence, and heartburn have been reported in about 1 of 100 patients.

Vomiting was a common occurrence. Post-marketing experience reveals very rare reports of hepatitis, jaundice and nonspecific hepatic dysfunction. Isolated cases of transaminase, alkaline phosphatase, and lactic dehydrogenase elevations have also been reported.

Hypersensitive Reactions Pruritus or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of psoriasis have been reported. Miscellaneous Peyronie’s disease has been reported in fewer than 1 of 100,000 patients.

Musculoskeletal pain, blurred vision, and tinnitus have also been reported. There have been rare reports of reversible alopecia, agranulocytosis, and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable.

There have been very rare reports of weight gain, arthritis, and retroperitoneal fibrosis (relationship to metoprolol has not been definitely established). The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with metoprolol. Myocardial Infarction Central Nervous System Tiredness has been reported in about 1 of 100 patients.

Vertigo, sleep disturbances, hallucinations, headache, dizziness, visual disturbances, confusion, and reduced libido have also been reported, but a drug relationship is not clear. Cardiovascular In the randomized comparison of metoprolol and placebo described in the CLINICAL PHARMACOLOGY section, the following adverse reactions were reported: Metoprolol Tartrate Tablets Placebo Hypotension (systolic BP < 90 mmHg) 27.4% 23.2% Bradycardia (heart rate < 40 beats/min) 15.9% 6.7% Second- or third-degree heart block 4.7% 4.7% First-degree heart block (P-R ≥ 0.26 sec) 5.3% 1.9% Heart failure 27.5% 29.6% Respiratory Dyspnea of pulmonary origin has been reported in fewer than 1 of 100 patients.

Gastrointestinal Nausea and abdominal pain have been reported in fewer than 1 of 100 patients. Dermatologic Rash and worsened psoriasis have been reported, but a drug relationship is not clear. Miscellaneous Unstable diabetes and claudication have been reported, but a drug relationship is not clear.

Potential Adverse Reactions A variety of adverse reactions not listed above have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to metoprolol. Central Nervous System Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. Cardiovascular Intensification of AV block (see CONTRAINDICATIONS ).

Hematologic Agranulocytosis, nonthrombocytopenic purpura and thrombocytopenic purpura. Hypersensitive Reactions Fever combined with aching and sore throa…

🔄 Drug Interactions 129 words ▾

Drug Interactions Catecholamine-Depleting Drugs Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Observe patients treated with metoprolol plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension. In addition, possibly significant hypertension may theoretically occur up to 14 days following discontinuation of the concomitant administration with an irreversible MAO inhibitor.

Digitalis Glycosides and Beta-Blockers Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Monitor heart rate and PR interval.

Calcium Channel Blockers Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reduction in myocardial contractility because of negative chronotropic and inotropic effects.

🤰 Pregnancy 144 words ▾

Pregnancy Pregnancy Category C Upon confirming the diagnosis of pregnancy, women should immediately inform their doctor. Metoprolol has been shown to increase postimplantation loss and decrease neonatal survival in rats at doses up to 11 times the maximum daily human dose of 450 mg, when based on surface area. Distribution studies in mice confirm exposure of the fetus when metoprolol is administered to the pregnant animal.

These limited animal studies do not indicate direct or indirect harmful effects with respect to teratogenicity (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility ). There are no adequate and well controlled studies in pregnant women. The amount of data on the use of metoprolol in pregnant women is limited.

The risk to the fetus/mother is unknown. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words ▾

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

🧓 Geriatric Use 134 words ▾

Geriatric Use Clinical trials of metoprolol in hypertension did not include sufficient numbers of elderly patients to determine whether patients over 65 years of age differ from younger subjects in their response to metoprolol. Other reported clinical experience in elderly hypertensive patients has not identified any difference in response from younger patients. In worldwide clinical trials of metoprolol in myocardial infarction, where approximately 478 patients were over 65 years of age (0 over 75 years of age), no age related differences in safety and effectiveness were found.

Other reported clinical experience in myocardial infarction has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some elderly individuals taking metoprolol cannot be categorically ruled out. Therefore, in general, it is recommended that dosing proceed with caution in this population.

🆘 Overdosage 163 words ▾

OVERDOSAGE Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD 50 ’s (mg/kg): mice, 1,158 to 2,460; rats, 3,090 to 4,670. Signs and Symptoms Potential signs and symptoms associated with overdosage with metoprolol are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure and death.

Management There is no specific antidote. In general, patients with acute or recent myocardial infarction may be more hemodynamically unstable than other patients and should be treated accordingly (see WARNINGS: Myocardial Infarction ). On the basis of the pharmacologic actions of metoprolol, the following general measures should be employed: Elimination of the Drug Gastric lavage should be performed.

Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. Hypotension Administer a vasopressor, e.g., norepinephrine or dopamine. Bronchospasm Administer a beta 2 -stimulating agent and/or a theophylline derivative.

Cardiac Failure Administer digitalis glycoside and diuretic. In shock resulting from inadequate cardiac contractility, consider administration of dobutamine, isoproterenol or glucagon.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocker. 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. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, 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.

Hypertension The mechanism of the antihypertensive effects of beta-blocking agents has not been fully 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. Angina Pectoris By blocking catecholamine-induced increases in heart rate, in velocity and extent of myocardial contraction and in blood pressure, metoprolol reduces the oxygen requirements of the heart at any given level of effort, thus making it useful in the long-term management of angina pectoris.

Myocardial Infarction The precise mechanism of action of metoprolol in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta 1 selectivity is demonstrated by the following: (1) In healthy subjects, metoprolol is unable to reverse the beta 2 -mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta 1 plus beta 2 ) 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. Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at doses much greater than required for beta-blockade. Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction.

Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within one hour after oral administration, and its duration is dose related. For example, a 50% reduction of the maximum effect after single oral doses of 20 mg, 50 mg and 100 mg occurred at 3.3 hours, 5 hours and 6.4 hours, respectively, in normal subjects. After repeated oral dosages of 100 mg twice daily, a significant reduction in exercise systolic blood pressure was evident at 12 hours.

When the drug was infused over a 10 minute period, in normal volunteers, maximum beta-blockade was achieved at approximately 20 minutes. Equivalent maximal beta-blocking effect is achieved with oral and intravenous doses in the ratio of approximately 2.5:1. There is a linear relationship between the log of plasma levels and reduction of exercise heart rate.

However, antihypertensive activity does not appear to be related to plasma levels. Because of variable plasma levels attained with a given dose and lack of a consistent relationship of antihypertensive activity to dose, selection of proper dosage requires individual titration . In several studies of patients with acute myocardial infarction, intravenous followed by oral administration of metoprolol caused a reduction in heart rate, systolic blood pressure and cardiac output.

Stroke volume, diastolic blood pressure and pulmonary artery end diastolic pressure remained unchanged. In patients with angina pectoris, plasma concentration measured at one hour is linearly related to the oral dose within the range of 50 mg to 400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to the logarithm of the ora…

🧬 Mechanism of Action 207 words ▾

Mechanism of Action Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocker. 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. Clinical pharmacology studies have demonstrated the beta-blocking activity of metoprolol, 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.

Myocardial Infarction The precise mechanism of action of metoprolol in patients with suspected or definite myocardial infarction is not known.

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Metoprolol Tartrate Tablets, USP are available containing 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate, USP. The 25 mg tablets are white, film-coated, round, scored tablets debossed with M over 18 on one side of the tablet and scored on the other side. They are available as follows: NDC 51407-109-01 bottles of 100 tablets NDC 51407-109-10 bottles of 1000 tablets The 50 mg tablets are pink, film-coated, round, scored tablets debossed with M over 32 on one side of the tablet and scored on the other side.

They are available as follows: NDC 51407-110-01 bottles of 100 tablets NDC 51407-110-10 bottles of 1000 tablets The 100 mg tablets are light blue, film-coated, round, scored tablets debossed with M over 47 on one side of the tablet and scored on the other side. They are available as follows: NDC 51407-111-01 bottles of 100 tablets NDC 51407-111-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Revised: 9/2018 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

📋 Description 183 words ▾

DESCRIPTION Metoprolol tartrate is a selective beta 1 -adrenoreceptor blocking agent, available as 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[ p- 2-methoxyethyl)phenoxy]-2-propanol (2:1) dextro -tartrate salt. Its structural formula is: Metoprolol tartrate, USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82.

It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Each tablet for oral administration contains 25 mg, 37.5 mg, 50 mg, 75 mg or 100 mg of metoprolol tartrate and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

The 37.5 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. The 50 mg tablets also contain FD&C Blue No.

2 Aluminum Lake, D&C Red No. 27 Aluminum Lake and FD&C Red No. 40 Aluminum Lake.

The 100 mg tablets also contain FD&C Blue No. 2 Aluminum Lake. Metoprolol Tartrate Structural Formula

💬 Information for Patients 102 words ▾

Information for Patients Advise patients to take metoprolol regularly and continuously, as directed, with or immediately following meals. If a dose should be missed, the patient should take only the next scheduled dose (without doubling it). Patients should not discontinue metoprolol 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 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.

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

alopecia: Loss of hair from the scalp or body.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

AV block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

bolus: A single dose given all at once, often as a quick push into a vein.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cross-sensitivity: The chance that someone allergic to one substance will also react to another, closely related substance.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

fertility: The natural ability to become pregnant or to father a child.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

wheezing: A high-pitched whistling sound made while breathing, usually when the airways are narrowed.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 71610-0555-45 · Aphena 71610-0557-70 · Aphena →

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.

Metoprolol Tartrate 25 mg Tablet, Film Coated, 120-count

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