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
7133518650
7 TABLET in 1 BOTTLE, PLASTIC (71335-1865-0)
ndc11
7133518651
30 TABLET in 1 BOTTLE, PLASTIC (71335-1865-1)
ndc11
7133518652
90 TABLET in 1 BOTTLE, PLASTIC (71335-1865-2)
ndc11
7133518653
60 TABLET in 1 BOTTLE, PLASTIC (71335-1865-3)
ndc11
7133518654
120 TABLET in 1 BOTTLE, PLASTIC (71335-1865-4)
ndc11
7133518655
100 TABLET in 1 BOTTLE, PLASTIC (71335-1865-5)
ndc11
7133518656
800 TABLET in 1 BOTTLE, PLASTIC (71335-1865-6)
ndc11
7133518657
1000 TABLET in 1 BOTTLE, PLASTIC (71335-1865-7)
ndc11
7133518658
180 TABLET in 1 BOTTLE, PLASTIC (71335-1865-8)
ndc11
7133518659
10 TABLET in 1 BOTTLE (71335-1865-9)

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": "71335-1865_ef2eb5d8-d32f-4b45-af1d-5efd4b9ebfb2",
  "productndc": "71335-1865",
  "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": "10"
}

Related drugs

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