Drug Database
Back to search

United States· US:43353-989_0e9a9053-4baf-4549-864b-4a35c92a7e06

Amlodipine besylate

A amlodipine product containing amlodipine besylate, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 18 of our 19 countries.

ATC C08CA01US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAmlodipine besylateATCC08CA01REGISTER NO.US:43353-989_0e9a9053…PACKS LISTED6CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about amlodipine besylateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Amlodipine is registered in 18 of 19 countries.

Countries holding a registration under ATC C08CA01 (amlodipine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 11 of them publish a price we can compare per daily dose
Search amlodipine products by name

Amlodipine · ATC C08CA01

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of amlodipine costs, country by country.

Normalised to the WHO defined daily dose (5 mg), the median price runs from $0.011 in United States to $0.49 in Switzerland — a ×47 gap.

  • United States: $0.011 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail
Open the full comparison — free accountDrug prices for market access

Amlodipine · price per daily dose (5 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$0.49
  • IT Italy$0.13
  • FR France$0.086
  • ES Spain$0.047
  • US United States$0.011 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMLODIPINE BESYLATE
Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Country
United States (US)
ATC code
C08CA01
ATC class
Amlodipine
Defined daily dose
5 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 6

  • ndc11
    43353-989-30
  • ndc11
    43353-989-45
  • ndc11
    43353-989-60
  • ndc11
    4335398930
    30 TABLET in 1 BOTTLE (43353-989-30)
  • ndc11
    4335398945
    45 TABLET in 1 BOTTLE (43353-989-45)
  • ndc11
    4335398960
    90 TABLET in 1 BOTTLE (43353-989-60)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

402 interactions on record for amlodipine.

Graded by severity as the source publishes them — 9 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan
Check amlodipine against other medicinesHow interaction checks work

Amlodipine · interactions on record

402 records

  • 9 severe
  • 195 moderate
  • 2 minor
  • 191 info

Most severe, free to view

  • DolasetronA04AA04severe
  • SimvastatinC10AA01severe
  • CeritinibL01ED02severe
  • CeritinibL01XE28severe

5 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Amlodipine in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All amlodipine products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Amlodibene Teva, Amlodilan
  • Belgium · Amlodipin Ab, Amlodipin Besilaat Sandoz
  • Bulgaria · Nordipin 10 Mg, Nordipin 5 Mg
  • Cyprus · Afiten, Amlobe
  • Czechia · Agen, Amlodipin Teva
  • Germany · Amlo Besilat Tad, Amlodipin (Besilat) Dexcel
  • Denmark · Adipine, Amlodipin 1a Farma
  • Estonia · Agen, Amlocard
  • Spain · Amlodipino Almus, Amlodipino Alter
  • Finland · Amlodipin Accord, Amlodipin Krka
  • France · Amlodipine Almus, Amlodipine Arrow
  • United Kingdom (Northern Ireland) · Amlodipine, Amlodipine Accord Healthcare
  • Greece · Abesyl, Amilopid
  • Croatia · Amlodipin Genericon, Amlodipin Pharmas
  • Hungary · Amlobesyl, Amlodipin Sandoz
  • Ireland · Amlode, Amlodipine 10 Mg
  • Iceland · Amló, Amlodipin Bluefish
  • Italy · Abis, Almidis
  • Lithuania · Agen, Alneta
  • Luxembourg · Amlodipin Besilaat Sandoz, Amlodipine Amlodipine Taw Pharma 1 mg/Ml Suspension Buvable
  • Latvia · Agen, Amlodipine Vitabalans
  • Malta · Amlodipina Ipca, Amlodipine Accord Healthcare
  • Netherlands · Amlober, Amlodipine (Als Besilaat) Accord
  • Norway · Amlodipin Accord, Amlodipin Sandoz
  • Poland · Adipine, Agen
  • Portugal · Amlocor, Amlodipina Accord
  • Romania · Almacor, Amlodipină Arena
  • Sweden · Amlodipin, Amlodipin Accord
  • Slovenia · Amlodipin Alkaloid-Int, Amlodipin Krka D.D.
  • Slovakia · Agen, Amlodipin Ratiopharm

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/db4850a2-1190-4a45-8a69-b427c10a86ec
GET /v1/drugs/db4850a2-1190-4a45-8a69-b427c10a86ec?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "ORAL",
  "source": "ndc",
  "strength": "10",
  "substance": "AMLODIPINE BESYLATE",
  "productndc": "43353-989",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA077955",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about amlodipine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

Try it freeOpen in the console