Amlodipine Besylate

In shortageOrange BookUNIISPLATC C08CA01

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeC08CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904637061
100 BLISTER PACK in 1 CARTON (0904-6370-61) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A078226

ABABAB

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": "0904-6370_56f23c85-5abd-443b-afcc-fafd8a8c8dab",
  "productndc": "0904-6370",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078226",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 9, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Jul 9, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Jul 9, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine Besylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine Besylate",
  "start_marketing_date": "20130120",
  "active_numerator_strength": "5"
}

Related drugs

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