United States· US:58151-065_164394b3-d7ba-4bbf-b64b-e2dd15735ea8

Caduet

A dihydropyridine derivatives product containing amlodipine and atorvastatin, registered in United States by Viatris Specialty LLC.

In shortageATC C08CAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: amlodipine and atorvastatin
Manufacturer: Viatris Specialty LLC
Country: United States (US)
ATC code: C08CA
ATC class: Dihydropyridine derivatives
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
5815106593
30 TABLET, FILM COATED in 1 BOTTLE (58151-065-93)

Regulatory notes

UNII (FDA substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

N021540

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet

Same class

Other records under C08CA

Dihydropyridine derivatives, as other registers publish it.

All amlodipine and atorvastatin products

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/65d0237d-bbcc-4a71-8baa-1e78be4cf735
GET /v1/drugs/65d0237d-bbcc-4a71-8baa-1e78be4cf735?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.

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6f1a9bd8-ee30-4c7d-932f-3fa8c4e087b6": {
      "match": "brand_token",
      "title": "CADUET (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM) TABLET, FILM COATED CADUET (AMLODIPINE AND ATORVASTATIN) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "51",
      "published_date": "2026-05-25"
    }
  },
  "productid": "58151-065_164394b3-d7ba-4bbf-b64b-e2dd15735ea8",
  "productndc": "58151-065",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021540",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 10MG BASE",
        "product_no": "005",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 20MG BASE",
        "product_no": "006",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 40MG BASE",
        "product_no": "007",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 80MG BASE",
        "product_no": "008",
        "approval_date": "Jan 30, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 10MG BASE",
        "product_no": "009",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 20MG BASE",
        "product_no": "010",
        "approval_date": "Jul 29, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 40MG BASE",
        "product_no": "011",
        "approval_date": "Jul 29, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Caduet",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021540",
  "marketing_category": "NDA",
  "nonproprietary_name": "amlodipine and atorvastatin",
  "start_marketing_date": "20260225",
  "active_numerator_strength": "5; 20"
}

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