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Amlodipine Besylate 5 mg Tablet, 90-count — NDC 65862-0102-90 package photo

Amlodipine Besylate 5 mg Tablet, 90-count

by Aurobindo Pharma Limited · 90 TABLET in 1 BOTTLE (65862-102-90)
NDC 65862-0102-90
🏷️ FDA NDC (as labeled) 65862-102-90 billing pads the product segment with a zero
This package
Contains90-count Medicaid pays$0.1777 / unit · 12 mo Per package$15.99 / 90 tablets · Medicaid Pack sizes5 compare ↓
Also priced by: Part D plans $0.0799/unit — full pricing hub ↓
Also comes in: 30 tablets 65862-0102-30 500 tablets 65862-0102-05 1000 tablets 65862-0102-99 6000 tablets 65862-0102-61
On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 65862-102-90
Product NDC 65862-102
11-digit billing NDC 65862010290
NCPDP billing unit EA — each (per item)
SPL Set ID b6f298ba-2d7e-4a3c-9edb-8b60aba716d6
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-07-17
Dosage form TABLET
Substance AMLODIPINE BESYLATE
GPI-14 34000003100330
GPI class amLODIPine Besylate
GCN Seq No 016926
GCN 02683
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 5 MG TAB
FDB brand name Amlodipine Besylate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65862-102-90 — 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 → 65862-0102-90. 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.

🏭 Manufacturer & labeler

LabelerAurobindo Pharma Limited
Labeler code65862
First marketedJul 2007
Product typeDrug For Further Processing
Portfolio1,452 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 AMLODIPINE BESYLATE 5 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
  • Amlodipine is used mainly to treat two things: high blood pressure and certain types of chest pain (angina). For high blood pressure, it's approved for adults and children as young...
  • The most common one is swelling in your ankles or legs — this is dose-related, so it's more noticeable at higher doses, and women tend to notice it more than men. Dizziness, flushi...
  • What side effects should I expect, and which ones should I call about?
  • You can take amlodipine with or without food — it doesn't make a meaningful difference in how well it's absorbed. Because it stays in your system for a long time (a half-life of 30...
📖 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.

💊 What it looks like

Color White
ShapeRound
ImprintC;59
Size1 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 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.

4 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.1777 $15.99 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.0799 $7.19 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amlodipine Besylate 5 mg 00480-7167-98 Teva 90 tablets $0.010 AB Discontinued —
Amlodipine Besylate 5 mg 00904-6370-61 Major 100 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 29300-0397-05 Unichem 500 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 42806-0056-05 Epic 500 tablets $0.010 AB Availability likely —
amlodipine besylate 5 mg 59762-2010-01 Mylan 1000 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 60687-0488-01 American 100 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 67877-0198-05 Ascend 500 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 67877-0901-05 Ascend 500 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 68180-0455-01 Lupin 90 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 68645-0515-54 Legacy 30 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 69097-0127-05 Cipla 90 tablets $0.010 AB Availability likely —
AMLODIPINE BESYLATE 5 mg 69584-0022-09 Oxford 90 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 82009-0027-10 Quallent 1000 tablets $0.010 AB Availability likely —
Amlodipine Besylate 5 mg 69097-0837-05 Cipla 90 tablets $0.014 AB FDA listed —
Norvasc 5 mg 00069-1530-41 PFIZER 100 tablets $8.138 AB Discontinued —
Norvasc 5 mg 58151-0354-30 Viatris 300 tablets $8.698 AB Availability likely —
Amlodipine Besylate 5 mg 00615-8430-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 42291-0026-10 AvKARE 1000 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 42708-0066-30 QPharma 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 43063-0564-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 43489-0100-01 China 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 48433-0156-20 Safecor 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 50090-2524-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 50090-5059-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 50090-6876-00 A-S 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 50090-6877-00 A-S 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 51407-0950-10 GSMS, 1000 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 51655-0044-52 Northwind 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 51655-0291-26 Northwind 90 tablets — AB FDA listed —
amlodipine besylate 5 mg 52605-0042-10 POLYGEN 1000 tablets — AB Discontinued —
Amlodipine Besylate 5 mg 55154-6892-00 Cardinal 10 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 55700-0543-30 Quality 30 tablets — AB Discontinued —
Amlodipine besylate 5 mg 63629-1024-02 Bryant 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 65841-0621-01 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mgthis 65862-0102-90 Aurobindo 90 tablets — — FDA listed —
Amlodipine Besylate 5 mg 67296-1876-09 Redpharm 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 68071-4251-01 NuCare 120 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 68071-5151-09 NuCare 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 68382-0122-01 Zydus 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 68788-8627-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 68788-9345-01 Preferred 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 70518-0835-00 REMEDYREPACK 30 tablets — AB Discontinued —
Amlodipine Besylate 5 mg 70518-2981-00 REMEDYREPACK 30 tablets — AB Discontinued —
Amlodipine Besylate 5 mg 70518-3592-00 REMEDYREPACK 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71205-0596-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71205-0599-30 Proficient 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71335-0473-00 Bryant 5 tablets — AB Discontinued —
Amlodipine Besylate 5 mg 71335-1278-00 Bryant 5 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71335-2359-00 Bryant 5 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71610-0539-60 Aphena 90 tablets — AB FDA listed —
AMLODIPINE BESYLATE 5 mg 71610-0687-15 Aphena 15 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71610-0691-15 Aphena 15 tablets — AB FDA listed —
Amlodipine besylate 5 mg 71610-0722-15 Aphena 15 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71610-0888-15 Aphena 15 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 71610-0956-30 Aphena 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 5 mg 71610-0985-60 Aphena 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 72189-0520-30 Direct_Rx 30 tablets — AB FDA listed —
AMLODIPINE BESYLATE 5 mg 72789-0261-90 PD-Rx 90 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 72789-0515-30 PD-Rx 30 tablets — AB FDA listed —
Amlodipine besylate 5 mg 76282-0238-05 Exelan 500 tablets — AB FDA listed —
Amlodipine besylate 5 mg 76282-0508-05 Exelan 500 tablets — AB FDA listed —
AMLODIPINE BESYLATE 5 mg 82804-0970-00 Proficient 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 83008-0035-30 Quality 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 87441-0017-01 Unit 30 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 00615-8654-05 NCS 15 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 60687-0972-01 American 100 tablets — AB FDA listed —
Amlodipine Besylate 5 mg 42708-0204-30 QPharma, 30 tablets — AB FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 65862-0102-90, 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.
📅 Q1 2025 – Q4 2025 · 4 quarters 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
90
Units reimbursed last 4 qtrs
5.3K
Gross reimbursed last 4 qtrs
$938.15
Avg / prescription
$10.42
Avg / unit
$0.1777
Latest quarter Q4 2025
42Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 90 Rx Managed care · 0 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: no data reported MI New York: 5,280 units · 27.0 per 100k residents 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: no data reported 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
27.027.0
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 New York 27.0 /100k
National units — by quarter
💵 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.
90 tablets this page65862-0102-90 126 Rx · $1,308
500 tablets65862-0102-05 No Medicaid data
30 tablets65862-0102-30 No Medicaid data
1000 tablets65862-0102-99 No Medicaid data
6000 tablets65862-0102-61 No Medicaid data
Drug total (last 4 qtrs): 126 Rx · 7,078 units · $1,308 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 Amlodipine Besylate (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Fatigue10,835
Nausea9,443
Diarrhoea8,945
Dyspnoea8,684
Dizziness7,742
Pain7,537
Headache7,386

Age at onset

Neonate35
Infant16
Child36
Adolescent76
Adult9,166
Elderly14,089

Reporter sex

168,900 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization61,348
Death15,098
Life-threatening7,111
Disabling4,816
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,506 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65862-0102-05 500 TABLET in 1 BOTTLE (65862-102-05) 2007-07-17 Active
65862-0102-30 30 TABLET in 1 BOTTLE (65862-102-30) 2007-07-17 Active
65862-0102-90 You're viewing this 90 TABLET in 1 BOTTLE (65862-102-90) 2007-07-17 Active
65862-0102-99 1000 TABLET in 1 BOTTLE (65862-102-99) 2007-07-17 Active
65862-0102-61 6000 TABLET in 1 BAG (65862-102-61) — Active

You're viewing one of 5 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65862-0102-90?
NDC 65862-0102-90 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 65862-0102-90 and NDC 65862-0102-30?
Both are Amlodipine Besylate 5 mg Tablet — the drug itself is identical. NDC 65862-0102-90 is the 90-count package, while NDC 65862-0102-30 is the 30 tablets package.
What NDC number is used to bill for this package of Amlodipine Besylate 5 mg Tablet?
Bill NDC 65862-0102-90 — the 11-digit billing format is 65862010290. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Aurobindo Pharma Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) ✓ Available
“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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65862-102-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65862-0102-90, written without dashes as 65862010290. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65862-0102-90, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0102) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. 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 4 other package presentations of this same product, including 30 tablets (65862-0102-30), 500 tablets (65862-0102-05), 1000 tablets (65862-0102-99). 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?
Aurobindo Pharma Limited 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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full FDA label FDA SPL

The complete FDA label for this product, 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
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Amlodipine besylate tablets are 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 ) 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 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal’s or Variant Angina) 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 tablets.

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 for angina…

⏱️ 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) 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 tablets 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 tablets 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 to 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 119 words ▾

3 DOSAGE FORMS AND STRENGTHS 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘57’ on the other side. 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged barrel shaped uncoated tablets, debossed with ‘C’ on one side and ‘58’ on the other side. 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘59’ on the other side.

Tablets: 2.5 mg, 5 mg, and 10 mg ( 3 )

⛔ Contraindications 19 words ▾

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

⚠️ Warnings and Cautions 162 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% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 Placebo N=520 2.5 mg N=275 5 mg N=296 10 mg N=268 Edema 1.8 3 10.8

0.6Dizziness 1.1 3.4 3.4

1.5Flushing 0.7 1.4 2.6 0 Palpitation 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% in placebo-controlled clinical trials include the following: Amlodipine Besylate (%) (N=1730) Placebo (%) (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 clinical…

🔄 Drug Interactions 191 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 amlodipine besylate 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% to 4% and 15% to 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 to 60%, and a lower in…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine besylate 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% to 4% and 15% to 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 117 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 to 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 (afterload) 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 to 114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90 to 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 bes…

🧬 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 (afterload) 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 ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets Amlodipine Besylate Tablets USP, 2.5 mg (amlodipine besylate equivalent to 2.5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘57’ on the other side, and is supplied as follows: Bottles of 30 NDC 65862-101-30 Bottles of 90 NDC 65862-101-90 Bottles of 500 NDC 65862-101-05 Bottles of 1,000 NDC 65862-101-99 5 mg Tablets Amlodipine Besylate Tablets USP, 5 mg (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white to off-white, flat, bevel edged barrel shaped uncoated tablets, debossed with ‘C’ on one side and ‘58’ on the other side, and is supplied as follows: Bottles of 30 NDC 65862-102-30 Bottles of 90 NDC 65862-102-90 Bottles of 500 NDC 65862-102-05 Bottles of 1,000 NDC 65862-102-99 10 mg Tablets Amlodipine Besylate Tablets USP, 10 mg (amlodipine besylate equivalent to 10 mg of amlodipine per tablet) are white to off-white, flat, bevel edged round uncoated tablets, debossed with ‘C’ on one side and ‘59’ on the other side, and is supplied as follows: Bottles of 30 NDC 65862-103-30 Bottles of 90 NDC 65862-103-90 Bottles of 500 NDC 65862-103-05 Bottles of 1,000 NDC 65862-103-99 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant containers as defined in the USP . Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 12/2021

📋 Description 127 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 molecular formula is C 20 H 25 CIN 2 O 5 •C 6 H 6 O 3 S, and its structural formula is: Amlodipine besylate USP 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: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Chemical Structure

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