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Amlodipine Besylate 10 mg Tablet, 30-count — NDC 70518-0297-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amlodipine Besylate 10 mg Tablet, 30-count — NDC 70518-0297-0 (Billing 70518-0297-00)

by REMEDYREPACK INC. · 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Amlodipine Besylate 10 mg Tablet from REMEDYREPACK INC., marketed since Mar 2017 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 70518-0297-00
🏷️ FDA NDC (as labeled) 70518-0297-0 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.0799/unit — full pricing hub ↓
Main listing for product 70518-0297 · Also comes in: 50 tablets 70518-0297-4 90 tablets 70518-0297-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-0297-0
Product NDC 70518-0297
11-digit billing NDC 70518029700
RxCUI 308135
UNII 864V2Q084H
Application # ANDA077073
SPL Set ID a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55
Established class (EPC) Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 3A Inhibitors
Chemical class Dihydropyridines
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-03-08
Route ORAL
Dosage form TABLET
Substance AMLODIPINE BESYLATE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 016927
GCN 02682
HICL code 006494
Ingredient (HICL) Amlodipine Besylate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A9
Therapeutic class — intermediate (HIC2) Calcium Antagonists
HIC3 code A9A
Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents
AHFS code 24:08.92.00
AHFS class Vasodilating Agents, Misc (24:08)
FDB label name AMLODIPINE BESYLATE 10 MG TAB
FDB brand name Amlodipine Besylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016927
  • GCN: 02682
  • HICL (First Databank): 006494
  • AHFS class code: 24:08.92.00
  • RxCUI (RxNorm): 308135
Why two NDCs? The FDA registers this code as 70518-0297-0 — a 5-4-1 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 package segment → 70518-0297-00. 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 Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker, Calcium Channel Blocker
Drug family (ATC) Renin-inhibitors, ACE inhibitors and calcium channel blockers, Dihydropyridine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AMLODIPINE BESYLATE 10 MG TAB Ingredient Amlodipine Besylate
📖 What it is MedlinePlus · NLM

Amlodipine is used to treat high blood pressure and certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have ches...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers high blood pressure, which reduces your risk of strokes and heart attacks. It also treats certain kinds of angina (chest pain) and coronary artery disease. Your doctor wi...
  • Take it by mouth, usually once a day, exactly as your prescriber directs. If you use Katerzia suspension, shake it first. It works gradually, so your dose may be adjusted over a we...
  • Ankle or foot swelling is the most common, especially at higher doses. Some people feel tired, dizzy, flushed, or sleepy, or notice a pounding heartbeat. Call your doctor if these...
  • Call if your chest pain worsens, you faint, you notice yellow skin or eyes, or you have swelling of the face or throat. Those need prompt attention.
📖 Read our full Amlodipine guide →
2
Nutrient depletion considerations

Amlodipine Besylate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0799 $2.40 / 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-0297-00 You're viewing this Main listing 30 TABLET in 1 BLISTER PACK 2017-03-08 — Active
70518-0297-01 70518-0297-1 90 TABLET in 1 BOTTLE, PLASTIC 2017-04-24 — Active
70518-0297-04 70518-0297-4 50 POUCH in 1 BOX / 1 TABLET in 1 POUCH 2026-04-22 — Active

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 blister pack.
How does this package differ from NDC 70518-0297-04?
Both are Amlodipine Besylate 10 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 70518-0297-04 is the 50 tablets package.
What NDC number is used to bill for this package of Amlodipine Besylate 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amlodipine Besylate 10 mg 00480-7168-98 Teva 90 tablets $0.015 AB Discontinued —
Amlodipine Besylate 10 mg 00904-6371-61 Major 100 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 29300-0398-05 Unichem 500 tablets $0.015 AB Availability likely —
amlodipine besylate 10 mg 59762-2135-01 Mylan 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 60687-0496-01 American 100 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 67877-0199-05 Ascend 500 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 67877-0902-10 Ascend 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68180-0721-03 Lupin 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68645-0516-54 Legacy 30 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 68645-0580-54 Legacy 30 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 69097-0128-05 Cipla 90 tablets $0.015 AB Availability likely —
AMLODIPINE BESYLATE 10 mg 69584-0023-09 Oxford 90 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 82009-0028-10 Quallent 1000 tablets $0.015 AB Availability likely —
Amlodipine Besylate 10 mg 42806-0057-05 Epic 500 tablets $0.017 AB FDA listed —
Amlodipine Besylate 10 mg 69097-0838-05 Cipla 90 tablets $0.019 AB FDA listed —
Norvasc 10 mg 00069-1540-41 PFIZER 100 tablets $11.190 AB Discontinued —
Norvasc 10 mg 58151-0355-77 Viatris 90 tablets $11.942 AB Availability likely —
Amlodipine Besylate 10 mg 00615-8431-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 42291-0027-10 AvKARE 1000 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 43063-0041-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 43353-0989-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 43489-0101-01 China 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 48433-0157-20 Safecor 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-2581-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5354-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5355-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-5550-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-6808-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 50090-6809-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51407-0951-10 GSMS, 1000 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51655-0586-52 Northwind 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 51655-0869-52 Northwind 30 tablets — AB FDA listed —
amlodipine besylate 10 mg 52605-0043-10 POLYGEN 1000 tablets — AB Discontinued —
Amlodipine Besylate 10 mg 55154-6875-00 Cardinal 10 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 60760-0445-30 ST. 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 63187-0914-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 65841-0622-01 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 65862-0103-05 Aurobindo 500 tablets — — FDA listed —
Amlodipine Besylate 10 mg 68071-2305-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-2520-09 NuCare 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 68071-3453-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-3698-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68382-0123-01 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-4085-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-7985-01 Preferred 100 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 68788-8451-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68788-8543-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mgthis 70518-0297-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 70518-2632-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 70518-4464-00 REMEDYREPACK 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71205-0488-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71205-0506-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-0218-01 Bryant 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 71335-0843-01 Bryant 30 tablets — AB Discontinued —
Amlodipine Besylate 10 mg 71335-0945-01 Bryant 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-1865-01 Bryant 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71335-1887-01 Bryant 30 tablets — — Discontinued —
Amlodipine Besylate 10 mg 71335-2507-00 Bryant 7 tablets — AB FDA listed —
amlodipine besylate 10 mg 71610-0469-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0620-30 Aphena 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 71610-0830-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0928-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0938-30 Aphena 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 71610-0978-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 71610-0988-30 Aphena 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 72189-0529-90 Direct_Rx 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 72789-0262-90 PD-Rx 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 72789-0516-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine besylate 10 mg 76282-0239-05 Exelan 500 tablets — AB FDA listed —
Amlodipine besylate 10 mg 76282-0509-05 Exelan 500 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 82804-0164-90 Proficient 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 10 mg 82804-0971-00 Proficient 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 82868-0031-90 Northwind 90 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 83209-0399-10 Boswell 10 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 87441-0016-01 Unit 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 68071-1980-02 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 67296-2297-03 Redpharm 30 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 00615-8652-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 60687-0961-01 American 100 tablets — AB FDA listed —
Amlodipine Besylate 10 mg 67046-1157-03 Coupler 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

🏛️
2017
On the market since
Mar 2017
📍
2026
Currently FDA-listed
9 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.

What it looks like

Color white
ShapeRound
Imprint128;C
Size8 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 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

5 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.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderCIPLA LTD
FDA applicationANDA077073 (ANDA)
Labeler code70518
First marketedMar 2017
Product typeHuman Prescription Drug
Portfolio1,527 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 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 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Amlodipine besylate tablet, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension (1.1) o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease (1.2) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal's or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%

1.1Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 amlodipine besylate tablet.

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 one 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. Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents.

1.2Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina.

Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION • Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) o Small, fragile, or elderly patients or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) • Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 )

2.1Adults The usual initial antihypertensive oral dose of amlodipine besylate tablet is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablet to other antihypertensive therapy. Adjust dosage according to blood pressure goals.

In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.

Most patients will require 10 mg for adequate effect. Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)].

2.2Children The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology ( 12.4 ), Clinical Studies ( 14.1 )].

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS • Tablets: 2.5 mg, 5 mg, and 10 mg ( 3 ) Tablets: 10 mg, white to off white round tablets with "128" debossed on one side and "C" on other side.

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS • Known sensitivity to amlodipine ( 4 ) Amlodipine besylate is contraindicated in patients with known sensitivity to amlodipine.

⚠️ Warnings and Cautions 165 words ▾

5 WARNINGS AND PRECAUTIONS • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Amlodipine besylate, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) • Titrate slowly in patients with severe hepatic impairment. ( 5.3 )

5.1Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

5.2Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate, particularly in patients with severe obstructive coronary artery disease.

5.3Patients with Hepatic Failure Because amlodipine besylate is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine besylate to patients with severe hepatic impairment.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited, India at 1-866-604-3268 or FDA at 1-800-FDA-1088 or 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. Amlodipine besylate has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily.

Most adverse reactions reported during therapy with amlodipine besylate were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine besylate because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below.

The incidence (%) of side effects that occurred in a dose related manner are as follows: Amlodipine besylate Placebo 2.5mg N=275 5mg N=296 10mg N=268 N=520 Edema 1.8 3.0 10.8

0.6Dizziness 1.1 3.4 3.4

1.5Flushing 0.7 1.4 2.6

0.0Palpitation 0.7 1.4 4.5

0.6Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following: Amlodipine besylate (%) Placebo (%) N=1730 N=1250 Fatigue 4.5

2.8Nausea 2.9

1.9Abdominal pain 1.6

0.3Somnolence 1.4

0.6For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table: Amlodipine besylate Placebo Male=% (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336) Edema 5.6 14.6 1.4

5.1Flushing 1.5 4.5 0.3

0.9Palpitations 1.4 3.3 0.9

0.9Somnolence 1.3 1.6 0.8

0.3The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis. Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: allergic reaction, asthenia, 1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal System: arthralgia, arthrosis, muscle cramps, 1 myalgia.

Psychiatric: sexual dysfunction (male 1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System: dyspnea, 1 epistaxis. Skin and Appendages: angioedema, erythema multiforme, pruritus 1 rash, 1 rash erythematous, rash maculopapular.

Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary System: micturition frequency, micturition disorder, nocturia. Autonomic Nervous System: dry mouth, sweating increased.

Metabolic and Nutritional: hyperglycemia, thirst. Hemopoietic: leukopenia, purpura, thrombocytopenia. 1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.

Amlodipine besylate therapy has not been associated with clini… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 194 words ▾

7 DRUG INTERACTIONS • Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 )

7.1Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology ( 12.3 )] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine.

Blood pressure should be closely monitored when amlodipine is co‑administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co‑administered with amlodipine [see Clinical Pharmacology ( 12.2 )] .

7.2Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology ( 12.3 )]. Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co‑administered.

Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pediatric: Effect on patients less than 6 years old is not known. ( 8.4 ) • Geriatric: Start dosing at the low end of the dose range. ( 8.5 )

8.1Pregnancy Risk Summary The limited available data based on post-marketing reports with NORVASC use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively.

However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data]. 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%-4% and 15%-20%, respectively. Clinical Considerations 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. Data Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis.

However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose.

8.2Lactation Risk Summary Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breastfed infant have been observed. There is no available information on the effects of amlodipine on milk production.

8.4Pediatric Use Amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies (14.1) ] . Effect of amlodipine besylate on blood pressure in patients less than 6 years of age is not known.

8.5Geriatric Use Clinical studies of amlodipine besylate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The limited available data based on post-marketing reports with NORVASC use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively.

However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data]. 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%-4% and 15%-20%, respectively. Clinical Considerations 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. Data Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis.

However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose.

🧒 Pediatric Use 46 words ▾

8.4Pediatric Use Amlodipine besylate (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies (14.1) ] . Effect of amlodipine besylate on blood pressure in patients less than 6 years of age is not known.

🧓 Geriatric Use 115 words ▾

8.5Geriatric Use Clinical studies of amlodipine besylate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required [see Dosage and Administration (2.1) ] .

🆘 Overdosage 161 words ▾

10 OVERDOSAGE Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine besylate is limited. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths.

Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential.

Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine besylate is highly protein bound, hemodialysis is not likely to be of benefit.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine.

Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina: In patients with exertional angina, amlodipine besylate reduces the total peripheral resistance (after load) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise.

Vasospastic Angina: Amlodipine besylate has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro . This inhibition of coronary spasm is responsible for the effectiveness of amlodipine besylate in vasospastic (Prinzmetal's or variant) angina.

12.2Pharmacodynamics Hemodynamics: Following administration of therapeutic doses to patients with hypertension, amlodipine besylate produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina.

With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine besylate is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (Diastolic pressure 105–114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90–104 mmHg).

Normotensive subjects experienced no clinically significant change in blood pressures (+1/–2 mmHg). In hypertensive patients with normal renal function, therapeutic doses of amlodipine besylate resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria. As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine besylate… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine.

Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following: Exertional Angina: In patients with exertional angina, amlodipine besylate reduces the total peripheral resistance (after load) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise.

Vasospastic Angina: Amlodipine besylate has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro . This inhibition of coronary spasm is responsible for the effectiveness of amlodipine besylate in vasospastic (Prinzmetal's or variant) angina.

📦 How Supplied / Storage and Handling 131 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 10 mg Tablets Amlodipine Besylate Tablets, USP - 10 mg (Amlodipine besylate USP equivalent to 10 mg of Amlodipine per tablet) are supplied as white to off white round tablets with "128" debossed on one side and "C" on other side and supplied as follows: NDC: 70518-0297-0 NDC: 70518-0297-1 NDC: 70518-0297-2 NDC: 70518-0297-3 NDC: 70518-0297-4 NDC: 70518-0297-5 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC OUTER PACKAGING: 50 in 1 BOX PACKAGING: 1 in 1 POUCH Storage Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Protect from light and moisture.

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 129 words ▾

11 DESCRIPTION Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: structure Amlodipine besylate is a white or almost white powder with a molecular weight of 567.1.

It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white to off white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Hemodynamics: Following administration of therapeutic doses to patients with hypertension, amlodipine besylate produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing. Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina.

With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with amlodipine besylate is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (Diastolic pressure 105–114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90–104 mmHg).

Normotensive subjects experienced no clinically significant change in blood pressures (+1/–2 mmHg). In hypertensive patients with normal renal function, therapeutic doses of amlodipine besylate resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria. As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine besylate have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume.

In hemodynamic studies, amlodipine besylate has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and man, even when co-administered with beta-blockers to man. Similar findings, however, have been observed in normal or well-compensated patients with heart failure with agents possessing significant negative inotropic effects. Electrophysiologic Effects: Amlodipine besylate does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man.

In patients with chronic stable angina, intravenous administration of 10 mg did not significantly alter A-H and H-V conduction and sinus node recovery time after pacing. Similar results were obtained in patients receiving amlodipine besylate and concomitant beta-blockers. In clinical studies in which amlodipine besylate was administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.

In clinical trials with angina patients alone, amlodipine besylate therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks. Drug interactions Sildenafil : When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect [see Drug Interactions ( 7.1 )].

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Effects in Hypertension Adult Patients The antihypertensive efficacy of amlodipine besylate has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine besylate and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension.

Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect. Tolerance was not demonstrated in patients studied for up to 1 year. The 3 parallel, fixed dose, dose response studies showed that the reduction in supine and standing blood pressures was dose-related within the recommended dosing range.

Effects on diastolic pressure were similar in young and older patients. The effect on systolic pressure was greater in older patients, perhaps because of greater baseline systolic pressure. Effects were similar in black patients and in white patients.

Pediatric Patients Two hundred sixty-eight hypertensive patients aged 6 to 17 years were randomized first to amlodipine besylate 2.5 or 5 mg once daily for 4 weeks and then randomized again to the same dose or to placebo for another 4 weeks. Patients receiving 2.5 mg or 5 mg at the end of 8 weeks had significantly lower systolic blood pressure than those secondarily randomized to placebo. The magnitude of the treatment effect is difficult to interpret, but it is probably less than 5 mmHg systolic on the 5 mg dose and 3.3 mmHg systolic on the 2.5 mg dose.

Adverse events were similar to those seen in adults.

14.2Effects in Chronic Stable Angina The effectiveness of 5 to 10 mg/day of amlodipine besylate in exercise-induced angina has been evaluated in 8 placebo-controlled, double-blind clinical trials of up to 6 weeks duration involving 1038 patients (684 amlodipine besylate, 354 placebo) with chronic stable angina. In 5 of the 8 studies, significant increases in exercise time (bicycle or treadmill) were seen with the 10 mg dose. Increases in symptom-limited exercise time averaged 12.8% (63 sec) for amlodipine besylate 10 mg, and averaged 7.9% (38 sec) for amlodipine besylate 5 mg.

Amlodipine besylate 10 mg also increased time to 1 mm ST segment deviation in several studies and decreased angina attack rate. The sustained efficacy of amlodipine besylate in angina patients has been demonstrated over long-term dosing. In patients with angina, there were no clinically significant reductions in blood pressures (4/1 mmHg) or changes in heart rate (+0.3 bpm).

14.3Effects in Vasospastic Angina In a double-blind, placebo-controlled clinical trial of 4 weeks duration in 50 patients, amlodipine besylate therapy decreased attacks by approximately 4/week compared with a placebo decrease of approximately 1/week (p<0.01). Two of 23 amlodipine besylate and 7 of 27 placebo patients discontinued from the study due to lack of clinical improvement.

14.4Effects in Documented Coronary Artery Disease In PREVENT, 825 patients with angiographically documented coronary artery disease were randomized to amlodipine besylate (5 to 10 mg once daily) or placebo and followed for 3 years. Although the study did not show significance on the primary objective of change in coronary luminal diameter as assessed by quantitative coronary angiography, the data suggested a favorable outcome with respect to fewer hospitalizations for angina and revascularization procedures in patients with CAD.

CAMELOT enrolled 1318 patients with CAD recently documented by angiography, without left main coronary disease and without heart failure or an ejection fraction <40%. Patients (76% males, 89% Caucasian, 93% enrolled at US sites, 89% with a history of angina, 52% without PCI, 4% with PCI and no stent, and 44% wi… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 168 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on a mg/m 2 basis, similar to the maximum recommended human dose of 10 mg amlodipine/day. 3 For the rat, the highest dose was, on a mg/m 2 basis, about twice the maximum recommended human dose.

3 Mutagenicity studies conducted with amlodipine maleate revealed no drug related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose 3 of 10 mg/day on a mg/m 2 basis). 3 Based on patient weight of 50 kg

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Amlodipine besylate tablets, USP (am loe' di peen bes' i late) Read this information carefully before you start taking Amlodipine besylate tablets and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor.

If you have any questions about Amlodipine besylate tablets, ask your doctor. Your doctor will know if Amlodipine besylate tablets is right for you. What is amlodipine besylate tablets?

Amlodipine besylate tablets is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

High Blood Pressure (hypertension) High blood pressure comes from blood pushing too hard against your blood vessels. Amlodipine besylate tablets relaxes your blood vessels, which lets your blood flow more easily and helps lower your blood pressure. Drugs that lower blood pressure lower your risk of having a stroke or heart attack.

Angina Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back.

Amlodipine besylate tablets can relieve this pain. Who should not use amlodipine besylate tablets? Do not use amlodipine besylate tablets if you are allergic to amlodipine (the active ingredient in amlodipine besylate tablets), or to the inactive ingredients.

Your doctor or pharmacist can give you a list of these ingredients. What should I tell my doctor before taking amlodipine besylate tablets? Tell your doctor about any prescription and non-prescription medicines you are taking, including natural or herbal remedies.

Tell your doctor if you: • ever had heart disease • ever had liver problems • are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets is the best treatment for you. • are breast-feeding. Amlodipine besylate passes into your milk.

How should I take amlodipine besylate tablets? • Take amlodipine besylate tablets once a day, with or without food. • It may be easier to take your dose if you do it at the same time every day, such as with breakfast or dinner, or at bedtime. Do not take more than one dose of amlodipine besylate tablets at a time. • If you miss a dose, take it as soon as you remember. Do not take amlodipine besylate tablets if it has been more than 12 hours since you missed your last dose.

Wait and take the next dose at your regular time. • Other medicines: You can use nitroglycerin and amlodipine besylate tablets together. If you take nitroglycerin for angina, don't stop taking it while you are taking amlodipine besylate tablets. • While you are taking amlodipine besylate tablets, do not stop taking your other prescription medicines, including any other blood pressure medicines, without talking to your doctor. • If you took too much amlodipine besylate tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

What should I avoid while taking amlodipine besylate tablets? • Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first. What are the possible side effects of amlodipine besylate tablets? Amlodipine besylate tablets may cause the following side effects.

Most side effects are mild or moderate: • swelling of your legs or ankles • tiredness, extreme sleepiness • stomach pain, nausea • dizziness • flushing (hot or warm feeling in your face) • arrhythmia (irregular heartbeat) • heart palpitations (very fast heartbeat) • muscle rigidity, tremor and/or abnormal muscle movement It is rare, but when you first start taking amlodipine besylate tablets or increase your dose, you may have a heart attack or your angina may ge… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 99 words ▾

DRUG: AMLODIPINE BESYLATE GENERIC: AMLODIPINE BESYLATE DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-0297-0 NDC: 70518-0297-1 NDC: 70518-0297-2 NDC: 70518-0297-3 NDC: 70518-0297-4 NDC: 70518-0297-5 COLOR: white SHAPE: ROUND SCORE: No score SIZE: 8 mm IMPRINT: 128;C PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 50 in 1 BOX PACKAGING: 1 in 1 POUCH ACTIVE INGREDIENT(S): AMLODIPINE BESYLATE 10mg in 1 INACTIVE INGREDIENT(S): CELLULOSE, MICROCRYSTALLINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE SILICON DIOXIDE MM1 MM2 MM3 MM4 MM5 MM6

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

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

Medicare Part D (outpatient prescription) spending for Amlodipine Besylate — the program that covers self-administered drugs. 21 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 Amlodipine Besylate. 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
$85.77M
Claims incl. refills
12.9M
Beneficiaries
9.9M
Spend / beneficiary
$8.67
Spend / claim
$6.65
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 50 tablets (70518-0297-04), 90 tablets (70518-0297-01). 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?
REMEDYREPACK INC. 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.
← 70518-0293-00 · REMEDYREPACK 70518-0305-00 · REMEDYREPACK →
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.