HomeNDC LookupIngredientsMetoprolol Succinate › 61919-0334-30
METOPROLOL SUCCINATE 100 mg Tablet, Extended Release, 30-count — NDC 61919-0334-30 package photo

METOPROLOL SUCCINATE 100 mg Tablet, Extended Release, 30-count

by Direct_Rx · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-30)
NDC 61919-0334-30
🏷️ FDA NDC (as labeled) 61919-334-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0707/unit — full pricing hub ↓
Also comes in: 90 tablets 61919-0334-90
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 →
⚠️
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

FDA NDC (as labeled) 61919-334-30
Product NDC 61919-334
11-digit billing NDC 61919033430
RxCUI 866412, 866924
UNII TH25PD4CCB
Application # ANDA078889
SPL Set ID 90a69a79-5517-0ccf-e053-2995a90a441f
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 2021-01-19
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METOPROLOL SUCCINATE
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
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-334-30 — 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 → 61919-0334-30. 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

LabelerDirect_Rx
Application holderDOCTOR REDDYS LABORATORIES LTD
FDA applicationANDA078889 (ANDA)
Labeler code61919
First marketedJan 2021
Product typeHuman Prescription Drug
Portfolio352 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METOPROLOL SUCC ER 100 MG TAB Ingredient Metoprolol Succinate
📖 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 →
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.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeRound
Imprint1
Size5 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII 0ZBX0N59RZ
    A plasticizer derived from citric acid that is added to tablet coatings and film formulations. It increases flexibility and durability of the coating layer, helping the tablet withstand handling and moisture without cracking.
  • 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 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 3DYK7UYZ62
    Ethylcellulose is a plant-fiber derivative used as a binder and film-coating agent in tablets and capsules. It helps hold ingredients together and can create a protective coating that controls how quickly the medicine dissolves.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 588X2YUY0A
    Methylene chloride is a volatile organic solvent used in pharmaceutical manufacturing to dissolve and process active ingredients and other substances. It evaporates during production, helping create tablets, capsules, or coatings with uniform quality.
  • UNII 30IQX730WE
    Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
  • 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 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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 $0.0707 $2.12 / 30 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metoprolol Succinate 100 mg 68001-0358-00 BluePoint 100 tablets $0.082 AB FDA listed
Metoprolol succinate 100 mg 70436-0166-01 Slate 100 tablets $0.086 AB Availability likely
Metoprolol succinate 100 mg 00904-6324-61 Major 1 tablet $0.091 AB Availability likely
Metoprolol Succinate 100 mg 27808-0304-01 Cranbury 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 31722-0591-01 Camber 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 42806-0726-01 Epic 100 tablets $0.091 AB Availability likely
metoprolol succinate 100 mg 45963-0677-11 Actavis 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 50268-0542-15 AvPAK 1 tablet $0.091 AB Availability likely
Metoprolol Succinate 100 mg 50742-0617-01 Ingenus 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 55111-0468-01 Dr. 100 tablets $0.091 Availability likely
Metoprolol Succinate 100 mg 60687-0413-01 American 1 tablet $0.091 AB Availability likely
Metoprolol Succinate 100 mg 67877-0592-01 Ascend 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 68001-0470-00 BluePoint 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 68001-0502-00 BluePoint 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 68001-0686-00 BluePoint 100 tablets $0.091 AB Availability likely
metoprolol succinate 100 mg 68382-0566-01 Zydus 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 70010-0782-01 Granules 100 tablets $0.091 AB Availability likely
Metoprolol Succinate 100 mg 72516-0032-01 Oryza 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 72603-0144-01 Northstar 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 75907-0345-01 Dr. 100 tablets $0.091 AB Availability likely
Metoprolol succinate 100 mg 82009-0115-05 Quallent 500 tablets $0.091 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 mgthis 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 mg 71205-0336-30 Proficient 30 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0334-30 You're viewing this 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-30) 2021-01-19 Active
61919-0334-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-334-90) 2021-01-19 Active

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

Pack size FAQ

What quantity is in NDC 61919-0334-30?
NDC 61919-0334-30 is a 30-count package — 30 tablet, extended release in 1 bottle.
What is the difference between NDC 61919-0334-30 and NDC 61919-0334-90?
Both are METOPROLOL SUCCINATE 100 mg Tablet, Extended Release — the drug itself is identical. NDC 61919-0334-30 is the 30-count package, while NDC 61919-0334-90 is the 90 tablets package.
What NDC number is used to bill for this package of METOPROLOL SUCCINATE 100 mg Tablet, Extended Release?
Bill NDC 61919-0334-30 — the 11-digit billing format is 61919033430. 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 61919-334-30, 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: 61919-0334-30, written without dashes as 61919033430. 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 61919-0334-30, the first segment (61919) is the labeler code FDA assigned to Direct_Rx; the middle segment (0334) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Direct_Rx. 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 1 other package presentation of this same product, including 90 tablets (61919-0334-90). 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?
Direct_Rx 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 104 words

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 tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event(see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).

⏱️ Dosage and Administration ~3 min read

Hypertension 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 in single or divided doses, whether used alone or added to a diuretic.

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. The effective dosage range of Metoprolol tartrate tablets is 100 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 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. The dosage may be gradually increased 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 to 400 mg per day.

Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, the dosage should be reduced gradually 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, treatment with metoprolol tartrate can be initiated 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. Treatment in this early phase should begin with the intravenous administration of three bolus injections of 5 mg of metoprolol tartrate each; the injections should be given at approximately 2-minute intervals. During the intravenous administration of metoprolol, blood pressure, heart rate,and electrocardiogram should be carefully monitored.In patients who tolerate the full intravenous dose (15 mg), metoprolol tartrate tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last intravenous dose and continued for 48 hours.

Thereafter, patients should receive a maintenance dosage of 100 mg twice daily (see Late Treatment below). Patients who appear not to tolerate the full intravenous dose should be started 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, treatment with metoprolol should be discontinued (see WARNINGS).

Late Treatment: 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 should be started on metoprolol tartrate tablets, 100 mg twice daily, as soon as their clinical condition allows. Therapy should be continued 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 Tartrate in pedi…

Contraindications 93 words

Hypertension and Angina Metoprolol tartrate is 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 ³ 0.24 sec); systolic blood pressure < 100 mmHg; or moderate-to-severe cardiac failure (see WARNINGS).

⚠️ Warnings ~2 min read

Heart Failure Beta blockers, like Metoprolol tartrate, 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 tartrate tablets or to discontinue it.

Ischemic Heart Disease Do not abruptly discontinue Metoprolol tartrate 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 tartrate, 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 tartrate 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 tartrate 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 tartrate. 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 tartrate. If severe bradycardia develops, reduce or stop metoprolol tartrate. Exacerbation of Bronchospastic Disease Patients with bronchospastic disease should, in general, not receive beta blockers, including metoprolol tartrate.

Because of its relative beta1 selectivity, however, metoprolol tartrate may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of metoprolol tartrate and consider administering metoprolol tartrate in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION).Bronchodilators, including beta2 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 tartrate may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.

🤒 Adverse Reactions ~2 min read

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 pre-existing 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 non-specific 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 has 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 tartrate has not been definitely established).

The oculomucocutaneous syndrome associated with the beta blocker practolol has not been reported with metoprolol tartrate. 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: [Table] 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 tartrate. 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, thrombocytopenic purpura. Hypersensitive Reactions: Fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Postmarketing Experience The following adverse reactions have been reported during postapproval use of metoprolol tartrate: confusional state, an increase in blood triglycerides and a decre…

🆘 Overdosage 169 words

Acute Toxicity Several cases of overdosage have been reported, some leading to death. Oral LD50’s (mg/kg): mice, 1158 to 2460; rats, 3090 to 4670. 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 tartrate, 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: A vasopressor should be administered, e.g., levarterenol or dopamine. Bronchospasm: A beta -stimulating agent and/or a theophylline derivative should be 2 administered.

Cardiac Failure: A digitalis glycoside and diuretic should be administered. In shock resulting from inadequate cardiac contractility, administration of dobutamine, isoproterenol, or glucagon may be considered.

🧬 Clinical Pharmacology ~3 min read

Mechanism of Action: Metoprolol Tartrate is a beta1-selective (cardioselective) adrenergic receptor blocker. This preferential effect is not absolute, however, and at higher plasma concentrations, Metoprolol Tartrate also inhibits beta2-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 Tartrate 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 Tartrate in patients with suspected or definite myocardial infarction is not known. Pharmacodynamics Relative beta1 selectivity is demonstrated by the following: (1) In healthy subjects, Metoprolol Tartrate is unable to reverse the beta2-mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective (beta1 plus beta2) beta blockers, which completely reverse the vasodilating effects of epinephrine.

(2) In asthmatic patients, Metoprolol Tartrate reduces FEV1 and FVC significantly less than a nonselective beta blocker, propranolol, at equivalent beta1-receptor blocking doses. Metoprolol Tartrate 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 Tartrate slows the sinus rate and decreases AV nodal conduction.

Significant beta-blocking effect (as measured by reduction of exercise heart rate) occurs within 1 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, 50, and 100 mg occurred at 3.3, 5.0, 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 Tartrate 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 1 hour is linearly related to the oral dose within the range of 50-400 mg. Exercise heart rate and systolic blood pressure are reduced in relation to…

📦 How Supplied / Storage and Handling ~1 min read

Metoprolol Tartrate Tablets USP, 25 mg - White, circular, film coated tablets debossed with "1" on one side and plain on the other side Bottles of 30 .................. Bottles of 90 ................. Bottles of 100 ................

Bottles of 1000 .............. Metoprolol Tartrate Tablets USP, 50 mg - Round, white film coated tablets with "477" debossed on one side and scored on the other side Bottles of 100 ................ Bottles of 1000...............

Metoprolol Tartrate Tablets USP, 50 mg - Capsule-shaped, biconvex, white, scored (debossed 166) Bottles of 100 ................ Bottles of 1000 .............. Metoprolol Tartrate Tablets USP, 100 mg - Round-shaped, film coated, white colored tablets debossed with '162' on one side and 'scored' on the other side.

Bottles of 90 ................... Bottles of 100 ................. Bottles of 1000 ...............

Metoprolol Tartrate Tablets USP, 100 mg - Capsule-shaped, biconvex, white, scored (debossed 167) Bottles of 90.................... Bottles of 100 ................. Bottles of 1000 ...............

Samples, when available, are identified by the word SAMPLE appearing on each bottle.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Protect from Moisture.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No.

259/15, Dadra-396 191, (U.T. of D & NH), India. 5094T89 Iss: 07/15

📋 Description 101 words

Metoprolol tartrate, USP is a selective beta1 -adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration. Metoprolol tartrate is (±)-1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol (2:1) dextro-tartrate salt, and its structural formula is: [Structure] 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.

Inactive Ingredients. Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.