Amlodipine Besylate

In shortageOrange BookUNIISPLATC C08CA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC08CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133523590
5 TABLET in 1 BOTTLE, PLASTIC (71335-2359-0)
ndc11
7133523591
30 TABLET in 1 BOTTLE, PLASTIC (71335-2359-1)
ndc11
7133523592
90 TABLET in 1 BOTTLE, PLASTIC (71335-2359-2)
ndc11
7133523593
60 TABLET in 1 BOTTLE, PLASTIC (71335-2359-3)
ndc11
7133523594
100 TABLET in 1 BOTTLE, PLASTIC (71335-2359-4)
ndc11
7133523595
180 TABLET in 1 BOTTLE, PLASTIC (71335-2359-5)
ndc11
7133523596
120 TABLET in 1 BOTTLE, PLASTIC (71335-2359-6)
ndc11
7133523597
10 TABLET in 1 BOTTLE, PLASTIC (71335-2359-7)
ndc11
7133523598
500 TABLET in 1 BOTTLE, PLASTIC (71335-2359-8)
ndc11
7133523599
1000 TABLET in 1 BOTTLE, PLASTIC (71335-2359-9)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A203245

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": "71335-2359_31134e23-cb5c-4ce1-9a09-f8222eab9b9b",
  "productndc": "71335-2359",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203245",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 21, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Oct 21, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Oct 21, 2013"
      }
    ],
    "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": "ANDA203245",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine Besylate",
  "start_marketing_date": "20190522",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code C08CA01.

Access this data programmatically

Query Amlodipine Besylate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs