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Metoprolol succinate 50 mg Tablet, Extended Release, 1,000-count — NDC 72516-0026-10 package photo

Metoprolol succinate 50 mg Tablet, Extended Release, 1,000-count

by Oryza pharmaceuticals Inc. · 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-10)
NDC 72516-0026-10
🏷️ FDA NDC (as labeled) 72516-026-10 billing pads the product segment with a zero
This package
Contains1,000-count Cost per ea$0.0571 NADAC Per package$57.10 / 1000 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2452/unit · Part D plans $0.2385/unit — full pricing hub ↓
Also comes in: 100 tablets 72516-0026-01 500 tablets 72516-0026-50
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

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

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

🆔 Identity & classification

FDA NDC (as labeled) 72516-026-10
Product NDC 72516-026
11-digit billing NDC 72516002610
NCPDP billing unit EA — each (per item)
RxCUI 866412, 866419, 866436
UNII TH25PD4CCB
UPC 0372516027100, 0372516028015, 0372516027018, 0372516027506 +3 more
Application # ANDA214110
SPL Set ID 151079c5-6360-45ed-8118-885543d6a4ad
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 2025-07-21
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance METOPROLOL SUCCINATE
GPI-14 33200030057520
GCN Seq No 016599
GCN 20741
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 50 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 72516-026-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72516-0026-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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

LabelerOryza pharmaceuticals Inc.
Application holderZHEJIANG JUTAI PHARMACEUTICAL CO LTD
FDA applicationANDA214110 (ANDA)
Labeler code72516
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio15 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 50 MG TAB Ingredient Metoprolol Succinate
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

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

💊 What it looks like

Color white
ShapeRound
ImprintKY;007
Size18 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 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 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 11628IH70O
    Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

11 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.057 $57.10 / 1000 tablets
Medicaid paysCMS SDUD · 12 mo $0.2452 $245.20 / 1000 tablets
Medicare drug plans payPart D · Q2 2026 $0.2385 $238.50 / 1000 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2026 Mar 2026 May 2026 Aug 2026 $0.061 $0.053
▼ Down 6% over the last 8 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metoprolol succinate 50 mg 70436-0183-01 Slate 100 tablets $0.054 AB Availability likely save 5%
Metoprolol succinate 50 mg 00904-6323-61 Major 1 tablet $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 27808-0303-01 Cranbury 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 31722-0590-01 Camber 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 42806-0725-01 Epic 100 tablets $0.057 AB Availability likely —
metoprolol succinate 50 mg 45963-0676-11 Actavis 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 50268-0541-15 AvPAK 1 tablet $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 50742-0616-01 Ingenus 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 55111-0467-01 Dr. 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 60687-0402-01 American 1 tablet $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 67877-0591-01 Ascend 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 68001-0469-00 BluePoint 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 68001-0501-00 BluePoint 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 68001-0685-00 BluePoint 100 tablets $0.057 AB Availability likely —
metoprolol succinate 50 mg 68382-0565-01 Zydus 100 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 70010-0781-01 Granules 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mgthis 72516-0026-10 Oryza 1000 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 72516-0031-01 Oryza 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 72603-0143-01 Northstar 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 75907-0347-01 Dr. 100 tablets $0.057 AB Availability likely —
Metoprolol succinate 50 mg 82009-0114-05 Quallent 500 tablets $0.057 AB Availability likely —
Metoprolol Succinate 50 mg 75834-0291-00 Nivagen 1000 tablets $0.059 — Discontinued +3%
Toprol Xl 50 mg 70842-0111-02 Melinta 100 tablets $1.385 AB Availability likely +2328%
Metoprolol succinate 50 mg 00615-7824-05 NCS 15 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 50090-5722-00 A-S 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 50090-5723-00 A-S 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 50090-6448-00 A-S 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 50090-6662-00 A-S 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 50090-6663-00 A-S 90 tablets — AB FDA listed —
Metoprolol succinate 50 mg 50090-7238-00 A-S 30 tablets — AB FDA listed —
Metoprolol succinate 50 mg 50090-7239-00 A-S 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 51407-0404-01 Golden 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 51655-0203-52 Northwind 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 51655-0519-26 Northwind 90 tablets — AB FDA listed —
Metoprolol succinate 50 mg 51655-0919-26 Northwind 90 tablets — AB FDA listed —
Metoprolol succinate 50 mg 53401-0009-30 Aphena 30 tablets — AB FDA listed —
Metoprolol succinate 50 mg 55154-6886-00 Cardinal 1 tablet — AB FDA listed —
metoprolol succinate 50 mg 60760-0634-90 St 90 tablets — AB FDA listed —
Metoprolol succinate 50 mg 60760-0993-90 ST. 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 62207-0133-49 Granules 1000 tablets — — FDA listed —
Metoprolol Succinate 50 mg 63629-8864-01 Bryant 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 63629-9169-01 Bryant 1000 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 63629-9170-01 Bryant 500 tablets — AB FDA listed —
Metoprolol succinate 50 mg 67046-1650-03 Coupler 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 67296-1902-03 Redpharm 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 68071-2522-01 NuCare 100 tablets — AB FDA listed —
Metoprolol succinate 50 mg 68071-3828-01 NuCare 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 68071-3943-01 NuCare 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 68071-3965-09 NuCare 90 tablets — AB FDA listed —
metoprolol succinate 50 mg 68788-7997-01 Preferred 100 tablets — AB Discontinued —
Metoprolol Succinate 50 mg 68788-8312-01 Preferred 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 68788-8869-03 Preferred 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 69097-0407-02 Cipla 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 70518-3164-00 REMEDYREPACK 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 70518-3680-00 REMEDYREPACK 90 tablets — AB Discontinued —
metoprolol succinate 50 mg 70771-1339-00 Zydus 1000 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71205-0162-30 Proficient 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71205-0179-30 Proficient 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71205-0724-30 Proficient 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 71205-0800-30 Proficient 30 tablets — AB FDA listed —
Metoprolol succinate 50 mg 71335-0149-01 Bryant 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 71335-1878-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71335-2835-01 Bryant 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71335-3052-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71335-9749-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71335-9753-01 Bryant 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 71610-0642-45 Aphena 45 tablets — AB FDA listed —
Metoprolol succinate 50 mg 71765-0006-01 Zhejiang 100 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 72162-1857-00 Bryant 1000 tablets — AB FDA listed —
Metoprolol Succinate ER 50 mg 72189-0547-90 Direct_Rx 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 72789-0010-30 PD-Rx 30 tablets — AB FDA listed —
Metoprolol succinate 50 mg 72789-0284-30 PD-Rx 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 72789-0497-90 PD-Rx 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 82804-0014-30 Proficient 30 tablets — AB FDA listed —
metoprolol succinate 50 mg 82804-0198-90 Proficient 90 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 82868-0084-30 Northwind 30 tablets — AB FDA listed —
Metoprolol succinate 50 mg 67046-1685-03 Coupler 30 tablets — AB FDA listed —
Metoprolol Succinate 50 mg 82804-0301-90 Proficient 90 tablets — AB FDA listed —
Metoprolol succinate 50 mg 67296-2301-03 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72516-0026-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q4 2025 · 1 quarter of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
45
Units reimbursed last 4 qtrs
1.5K
Gross reimbursed last 4 qtrs
$357.04
Avg / prescription
$7.93
Avg / unit
$0.2452
Latest quarter Q4 2025
45Rx
Medicaid pays / ea
$0.2452
gross reimbursed
vs
NADAC / ea
$0.0571
acquisition cost
=
Spread
+$0.1881
+329% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 45 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 540 units · 5.4 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 570 units · 12.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.412.5
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 12.5 /100k
2 Michigan 5.4 /100k
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 tablets this page72516-0026-10 45 Rx · $357
100 tablets72516-0026-01 No Medicaid data
500 tablets72516-0026-50 No Medicaid data
Drug total (last 4 qtrs): 45 Rx · 1,456 units · $357 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for 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 Per unit Per pack Marketing startStatus
72516-0026-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-01) — — 2025-07-21 Active
72516-0026-10 You're viewing this 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-10) $0.0571 / ea $57.05 2025-07-21 Active
72516-0026-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-026-50) — — 2025-07-21 Active

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

Pack size FAQ

What quantity is in NDC 72516-0026-10?
NDC 72516-0026-10 is a 1,000-count package — 1000 tablet, extended release in 1 bottle.
What is the difference between NDC 72516-0026-10 and NDC 72516-0026-01?
Both are Metoprolol succinate 50 mg Tablet, Extended Release — the drug itself is identical. NDC 72516-0026-10 is the 1,000-count package, while NDC 72516-0026-01 is the 100 tablets package.
What NDC number is used to bill for this package of Metoprolol succinate 50 mg Tablet, Extended Release?
Bill NDC 72516-0026-10 — the 11-digit billing format is 72516002610. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Metoprolol succinate, is a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Angina Pectoris. ( 1.2 ) Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3 )

1.1Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol.

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

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

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

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

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

1.3Heart Failure Metoprolol succinate extended-release tablets are indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer once daily. Titrate at weekly or longer intervals as needed and tolerated. ( 2 ) Hypertension: Starting dose is 25 to 100 mg. ( 2.1 ) Angina Pectoris: Starting dose is 100 mg. ( 2.2 ) Heart Failure: Starting dose is 12.5 or 25 mg. ( 2.3 ) Switching from immediate-release metoprolol to extended-release metoprolol succinate: use the same total daily dose of metoprolol succinate extended-release tablets. ( 2 )

2.1Hypertension Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. Adjust 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 1 week of therapy.

Dosages above 400 mg per day have not been studied. Pediatric Hypertensive Patients ≥ 6 Years of age: The recommended starting dose of metoprolol succinate extended-release tablets are 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Adjust dosage according to blood pressure response.

Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3) ]. Metoprolol succinate extended-release tablets have not been studied in pediatric patients < 6 years of age [see Use in Specific Populations (8.4) ].

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

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

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

Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of metoprolol succinate extended-release tablets. Initial difficulty with titration should not preclude later attempts to introduce metoprolol succinate extended-release tablets. If patients experience symptomatic bradycardia, reduce the dose of metoprolol succinate extended-release tablets.

If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of metoprolol succinate extended-release tablets, or temporarily discontinuing it. The dose of metoprolol succinate extended-release tablets should not be increased until symptoms of worsening heart failure have been stabilized.

2.4Administration Metoprolol succinate extended-release tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS 50 mg tablets: White to off-white round film coated tablets, scored on one side and debossed “KY004” on other side. 100 mg tablets: White to off-white round film coated tablets, scored on one side and debossed “KY005” on other side. 200 mg tablets: White to off-white oval film coated tablets, scored on both sides and debossed “KY007” on one side. Metoprolol Succinate Extended-Release Tablets: 50 mg, 100 mg, and 200 mg. ( 3 )

⛔ Contraindications 78 words ▾

4 CONTRAINDICATIONS Metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. Known hypersensitivity to product components. ( 4 ) Severe bradycardia: Greater than first degree heart block, or sick sinus syndrome without a pacemaker.

( 4 ) Cardiogenic shock or decompensated heart failure. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Abrupt cessation may exacerbate myocardial ischemia. ( 5.1 ) Heart Failure: Worsening cardiac failure may occur. ( 5.2 ) Bronchospastic Disease: Avoid beta-blockers.

( 5.3 ) Concomitant use of glycosides, clonidine, diltiazem and verapamil with beta-blockers can increase the risk of bradycardia. ( 5.4 ) Pheochromocytoma: Initiate therapy with an alpha-blocker. ( 5.5 ) Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery.

Do not routinely withdraw chronic beta-blocker therapy prior to surgery. ( 5.6 , 6.1 ) Hypoglycemia: May increase risk for hypoglycemia and mask early warning signs. ( 5.7 ) Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm.

( 5.8 ) Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. ( 5.9 ) Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. ( 5.10 )

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

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

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

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

5.3Bronchospastic Disease Patients with bronchospastic diseases should, in general, not receive beta-blockers. Because of its relative beta 1 - cardio-selectivity, however, metoprolol succinate extended-release tablets may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta 1 -selectivity is not absolute, use the lowest possible dose of metoprolol succinate extended-release tablets.

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

5.4Bradycardia Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of metoprolol succinate extended-release tablets. Patients with first-degree atrioventricular block, sinus node dysfunction, conduction disorders (including Wolff-Parkinson-White) or on concomitant drugs that cause bradycardia [see Drug Interactions (7.3) ] , may be at increased risk. Monitor heart rate in patients receiving metoprolol succinate extended-release tablets.

If severe bradycardia develops, reduce or stop metoprolol succinate extended-release tablets.

5.5Pheochromocytoma If metoprolol succinate extended-release tablets are used in the setting of pheochromocytoma, they 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 bet…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: Worsening angina or myocardial infarction [see Warnings and Precautions (5) ]. Worsening heart failure [see Warnings and Precautions (5) ]. Worsening AV block [see Contraindications (4) ].

Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oryza Pharmaceuticals, Inc. at 1-866-637-4281 or FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch .

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

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

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

1.0Bradycardia 1.5

0.4Post-operative Adverse Events: In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, metoprolol succinate extended-release tablets 100 mg were started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metoprolol succinate extended-release tablets use was associated with a higher incidence of bradycardia (6.6% vs. 2.4%; HR 2.74; 95% CI 2.19, 3.43), hypotension (15% vs.

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

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

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

Hypersensitive Reactions: Pruritus. Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, sweating, photosensitivity, taste disturbance. Potential Adverse Reactions: In additio…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Catecholamine-depleting drugs may have an additive effect when given with beta-blocking agents. ( 7.1 ) CYP2D6 Inhibitors are likely to increase metoprolol concentration. ( 7.2 ) Beta-blockers including metoprolol, may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. ( 7.3 )

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

7.2CYP2D6 Inhibitors Drugs that are strong inhibitors of CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone were shown to double metoprolol concentrations. While there is no information about moderate or weak inhibitors, these too are likely to increase metoprolol concentration. Increases in plasma concentration decrease the cardioselectivity of metoprolol [see Clinical Pharmacology (12.3) ] .

Monitor patients closely when the combination cannot be avoided.

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

If replacing clonidine by beta-blocker therapy, delay the introduction of beta-blockers for several days after clonidine administration has stopped.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Consider initiating metoprolol succinate extended-release therapy at low doses and gradually increase dosage to optimize therapy, while monitoring closely for adverse events. ( 8.6 )

8.1Pregnancy Risk Summary Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations ) . Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. However, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta-blockers, including metoprolol, during pregnancy (see Data ) .

In animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 24 times the daily dose of 200 mg in a 60-kg patient on a mg/m 2 basis. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical consideration Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. There is a risk for preterm birth with pregnant women with chronic heart failure in 3rd trimester of pregnancy.

Fetal/Neonatal adverse reactions Metoprolol crosses the placenta. Neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. Observe neonates and manage accordingly.

Data Human Data Data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol in pregnancy. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth, and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. Methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother.

These observational studies cannot definitively establish or exclude any drug-associated risk during pregnancy. Animal Data Metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e., 24 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. No fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e., 10 times, the daily dose of 200 mg in a 60-kg patient.

8.2Lactation Risk Summary Limited available data from published literature report that metoprolol is present in human milk. The estimated daily infant dose of metoprolol received from breastmilk ranges from 0.05 mg to less than 1 mg. The estimated relative infant dosage was 0.5% to 2% of the mother's weight-adjusted dosage (see Data ) . No adverse reactions of metoprolol on the breastfed infant have been identified. Th…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus (see Clinical Considerations ) . Available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. However, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta-blockers, including metoprolol, during pregnancy (see Data ) .

In animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 24 times the daily dose of 200 mg in a 60-kg patient on a mg/m 2 basis. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical consideration Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. There is a risk for preterm birth with pregnant women with chronic heart failure in 3rd trimester of pregnancy.

Fetal/Neonatal adverse reactions Metoprolol crosses the placenta. Neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. Observe neonates and manage accordingly.

Data Human Data Data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol in pregnancy. The published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth, and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. Methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother.

These observational studies cannot definitively establish or exclude any drug-associated risk during pregnancy. Animal Data Metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e., 24 times, on a mg/m 2 basis, the daily dose of 200 mg in a 60-kg patient. No fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e., 10 times, the daily dose of 200 mg in a 60-kg patient.

🧒 Pediatric Use 179 words ▾

8.4Pediatric Use One hundred forty-four hypertensive pediatric patients aged 6 to 16 years were randomized to placebo or to one of three dose levels of metoprolol succinate extended-release tablets (0.2 mg/kg, 1 mg/kg or 2 mg/kg once daily) and followed for 4 weeks. The study did not meet its primary endpoint (dose response for reduction in SBP). Some pre-specified secondary endpoints demonstrated effectiveness including: Dose-response for reduction in DBP, 1 mg/kg vs. placebo for change in SBP, and 2 mg/kg vs. placebo for change in SBP and DBP.

The mean placebo corrected reductions in SBP ranged from 3 to 6 mmHg, and DBP from 1 to 5 mmHg. Mean reduction in heart rate ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals [see Dosage and Administration (2.1) ] . No clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients.

Safety and effectiveness of metoprolol succinate extended-release tablets have not been established in patients < 6 years of age.

🧓 Geriatric Use 134 words ▾

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

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

🆘 Overdosage 185 words ▾

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

Patients with myocardial infarction or heart failure may be prone to significant hemodynamic instability. Beta-blocker overdose may result in significant resistance to resuscitation with adrenergic agents, including beta-agonists. On the basis of the pharmacologic actions of metoprolol, employ the following measures: Hemodialysis is unlikely to make a useful contribution to metoprolol elimination [see Clinical Pharmacology (12.3) ] .

Bradycardia: Evaluate the need for atropine, adrenergic-stimulating drugs, or pacemaker to treat bradycardia and conduction disorders. Hypotension: Treat underlying bradycardia. Consider intravenous vasopressor infusion, such as dopamine or norepinephrine.

Heart failure and shock: May be treated when appropriate with suitable volume expansion, injection of glucagon (if necessary, followed by an intravenous infusion of glucagon), intravenous administration of adrenergic drugs such as dobutamine, with α 1 receptor agonistic drugs added in presence of vasodilation. Bronchospasm: Can usually be reversed by bronchodilators.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -adrenoreceptors, chiefly located in the bronchial and vascular musculature. Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade.

Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction. The relative beta 1 -selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta 2 -mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective beta-blockers, which completely reverse the vasodilating effects of epinephrine.

(2) In asthmatic patients, metoprolol reduces FEV 1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta 1 -receptor blocking doses. Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity.

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. Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

12.2Pharmacodynamics Clinical pharmacology studies have confirmed the beta-blocking activity of metoprolol in man, as shown by (1) reduction in heart rate and cardiac output at rest and upon exercise, (2) reduction of systolic blood pressure upon exercise, (3) inhibition of isoproterenol-induced tachycardia, and (4) reduction of reflex orthostatic tachycardia. The relationship between plasma metoprolol levels and reduction in exercise heart rate is independent of the pharmaceutical formulation. Beta 1 -blocking effects in the range of 30-80% of the maximal effect (approximately 8 to 23% reduction in exercise heart rate) correspond to metoprolol plasma concentrations from 30 to 540 nmol/L.

The relative beta 1 -selectivity of metoprolol diminishes and blockade of beta 2 -adrenoceptors increases at plasma concentration above 300 nmol/L. In five controlled studies in normal healthy subjects, extended-release metoprolol succinate administered once a day, and immediate-release metoprolol administered once to four times a day, provided comparable total beta 1 -blockade over 24 hours (area under the beta 1 -blockade versus time curve) in the dose range 100 to 400 mg. In another controlled study, 50 mg once daily for each product, extended-release metoprolol succinate produced significantly higher total beta 1 -blockade over 24 hours than immediate-release metoprolol.

For extended-release metoprolol succinate, the percent reduction in exercise heart rate was relatively stable throughout the entire dosage interval and the level of beta 1 -blockade increased with increasing doses from 50 to 300 mg daily. A controlled cross-over study in heart failure patients compared the plasma concentrations and beta 1 -blocking effects of 50 mg immediate-release metoprolol administered t.i.d., and 100 mg and 200 mg extended-release metoprolol succinate once daily. Extended-release metoprolol succinate 200 mg once daily produced a larger effect on suppression of exercise-induced and Holter-monitored heart rate ove…

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Metoprolol is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent. This preferential effect is not absolute, however, and at higher plasma concentrations, metoprolol also inhibits beta 2 -adrenoreceptors, chiefly located in the bronchial and vascular musculature. Metoprolol has no intrinsic sympathomimetic activity, and membrane-stabilizing activity is detectable only at plasma concentrations much greater than required for beta-blockade.

Animal and human experiments indicate that metoprolol slows the sinus rate and decreases AV nodal conduction. The relative beta 1 -selectivity of metoprolol has been confirmed by the following: (1) In normal subjects, metoprolol is unable to reverse the beta 2 -mediated vasodilating effects of epinephrine. This contrasts with the effect of nonselective beta-blockers, which completely reverse the vasodilating effects of epinephrine.

(2) In asthmatic patients, metoprolol reduces FEV 1 and FVC significantly less than a nonselective beta-blocker, propranolol, at equivalent beta 1 -receptor blocking doses. Hypertension: The mechanism of the antihypertensive effects of beta-blocking agents has not been elucidated. However, several possible mechanisms have been proposed: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output; (2) a central effect leading to reduced sympathetic outflow to the periphery; and (3) suppression of renin activity.

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. Heart Failure: The precise mechanism for the beneficial effects of beta-blockers in heart failure has not been elucidated.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets containing metoprolol succinate equivalent to the indicated weight of metoprolol tartrate, USP, are white to off-white, film-coated, and scored. Tablet Shape Engraving Bottle of 100 NDC 72516- Bottle of 500 NDC 72516- Bottle of 1000 NDC 72516- 50 mg Round KY004 026-01 026-50 026-10 100 mg Round KY005 027-01 027-50 027-10 200 mg Oval KY007 028-01 N/A N/A Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F).

(See USP Controlled Room Temperature.)

📋 Description 182 words ▾

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

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

Its structural formula is: Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, ethylcellulose, polyethylene oxide, croscarmellose sodium, stearic acid, polyvinyl alcohol, titanium dioxide, talc, lecithin.

FDA approved dissolution test specifications differ from USP. structure

💬 Information for Patients ~1 min read ▾

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

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

Risk of hypoglycemia Inform patients or caregivers that there is a risk of hypoglycemia when metoprolol succinate extended-release tablets are given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia. [see Warnings and Precautions (5.7) ]. Manufactured for: Oryza Pharmaceuticals, Inc.

Coral Springs, FL 33065 Manufactured By: Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd 333 Jiangnan Road, Hengdian, Dongyang, Zhejiang, 322118, China. Rev. 03/2026 SOP-YMQA-3331ZB/B02-02

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72516-0024-10 · Oryza 72516-0027-01 · Oryza →
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.