Amlodipine and Atorvastatin

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4670875830
30 TABLET, FILM COATED in 1 BOTTLE (46708-758-30)
ndc11
4670875890
90 TABLET, FILM COATED in 1 BOTTLE (46708-758-90)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A217279

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amlodipine Besylate; Benazepril Hydrochloride Capsule

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": "46708-758_ecab983e-6ed8-4440-b7b4-7ac4bf39b26c",
  "productndc": "46708-758",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217279",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 20MG BASE",
        "product_no": "005",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 40MG BASE",
        "product_no": "006",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 80MG BASE",
        "product_no": "007",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 10MG BASE",
        "product_no": "008",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 20MG BASE",
        "product_no": "009",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 40MG BASE",
        "product_no": "010",
        "approval_date": "May 22, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 80MG BASE",
        "product_no": "011",
        "approval_date": "May 22, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine and Atorvastatin",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA217279",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine and Atorvastatin",
  "start_marketing_date": "20250523",
  "active_numerator_strength": "5; 10"
}

Related drugs

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