Amlodipine besylate and Atorvastatin calcium

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerDr. Reddy's Laboratories Inc

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4359831405
500 TABLET, FILM COATED in 1 BOTTLE (43598-314-05)
ndc11
4359831430
30 TABLET, FILM COATED in 1 BOTTLE (43598-314-30)
ndc11
4359831460
60 TABLET, FILM COATED in 1 BOTTLE (43598-314-60)
ndc11
4359831490
90 TABLET, FILM COATED in 1 BOTTLE (43598-314-90)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A203874

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": "43598-314_54058ac6-94e2-d2d3-5c46-886b3478fc76",
  "productndc": "43598-314",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203874",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 10MG BASE",
        "product_no": "004",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 20MG BASE",
        "product_no": "005",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 40MG BASE",
        "product_no": "006",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;EQ 80MG BASE",
        "product_no": "007",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 10MG BASE",
        "product_no": "008",
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      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 20MG BASE",
        "product_no": "009",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 40MG BASE",
        "product_no": "010",
        "approval_date": "Mar 7, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;EQ 80MG BASE",
        "product_no": "011",
        "approval_date": "Mar 7, 2014"
      }
    ],
    "appl_type": "A"
  },
  "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 besylate and Atorvastatin calcium",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203874",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine besylate and Atorvastatin calcium",
  "start_marketing_date": "20140317",
  "active_numerator_strength": "5; 80"
}

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