Amlodipine and Atorvastatin

In shortageOrange BookUNIISPLATC C08CA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPrasco Laboratories

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6699326630
30 TABLET, COATED in 1 BOTTLE (66993-266-30)

Annotations

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

Raw payload (JSON)

{
  "unii": {
    "unii": "864V2Q084H",
    "rxcui": "104416",
    "inchikey": "ZPBWCRDSRKPIDG-UHFFFAOYSA-N",
    "display_name": "AMLODIPINE BESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6efc0ef6-0424-44fc-a9ea-eb30c3b83239": {
      "match": "brand_token",
      "title": "AMLODIPINE BESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66993-266_c09c6dd4-0101-4551-878c-f28080948160",
  "productndc": "66993-266",
  "dosage_form": "TABLET, 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": "Amlodipine and Atorvastatin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021540",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Amlodipine and Atorvastatin",
  "start_marketing_date": "20220314",
  "active_numerator_strength": "5; 10"
}

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