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United States· US:43598-319_54058ac6-94e2-d2d3-5c46-886b3478fc76

Amlodipine besylate and Atorvastatin calcium

A atorvastatin and amlodipine product containing amlodipine besylate; atorvastatin calcium trihydrate, registered in United States by Dr. Reddy's Laboratories Inc. The same ATC class is registered in 7 of our 19 countries.

ATC C10BX03US 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 besylate and Atorvastatin …ATCC10BX03REGISTER NO.US:43598-319_54058ac6…PACKS LISTED8CHECKEDSeptember 27, 2026

Where it is registered

Atorvastatin and amlodipine is registered in 7 of 19 countries.

Countries holding a registration under ATC C10BX03 (atorvastatin and amlodipine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Atorvastatin and amlodipine · ATC C10BX03

7 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Finlandprice
  • Polandprice
  • Switzerlandprice
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Manufacturer
Dr. Reddy's Laboratories Inc
Country
United States (US)
ATC code
C10BX03
ATC class
Atorvastatin and amlodipine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 8

  • ndc11
    43598-319-05
  • ndc11
    43598-319-30
  • ndc11
    43598-319-60
  • ndc11
    43598-319-90
  • ndc11
    4359831905
    500 TABLET, FILM COATED in 1 BOTTLE (43598-319-05)
  • ndc11
    4359831930
    30 TABLET, FILM COATED in 1 BOTTLE (43598-319-30)
  • ndc11
    4359831960
    60 TABLET, FILM COATED in 1 BOTTLE (43598-319-60)
  • ndc11
    4359831990
    90 TABLET, FILM COATED in 1 BOTTLE (43598-319-90)

Regulatory notes

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

Interactions

4 interactions on record for atorvastatin and amlodipine.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Atorvastatin and amlodipine · interactions on record

4 records

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

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Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Atorvastatin and amlodipine in 8 other countries

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

All atorvastatin and amlodipine products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

  • Austria · Atorvalan Comp., Caduet
  • Bulgaria · Амлатор, Атордапин
  • Czechia · Amlator, Caduet
  • Germany · Amloator
  • Spain · Amlodipino/Atorvastatina Krka, Amlodipino/Atorvastatina Normon
  • France · Amlodipine/Atorvastatine Viatris, Caduet
  • Croatia · Atordapin, Caduet
  • Hungary · Amlator, Caduet
  • Lithuania · Atordapin
  • Latvia · Atordapin, Caduet
  • Poland · Amlator
  • Portugal · Caduet, Trinalion
  • Romania · Caduet, Lirtonen
  • Slovenia · Amaloris, Lirtonen
  • Slovakia · Amlator, Dicartil

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/b053b356-7c8b-4281-a256-78f17aa1b55a
GET /v1/drugs/b053b356-7c8b-4281-a256-78f17aa1b55a?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": "5; 20",
  "substance": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
  "productndc": "43598-319",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA203874",
  "marketing_category": "ANDA"
}

See everything about atorvastatin and 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.