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
7133504730
5 TABLET in 1 BOTTLE (71335-0473-0)
ndc11
7133504731
30 TABLET in 1 BOTTLE (71335-0473-1)
ndc11
7133504732
90 TABLET in 1 BOTTLE (71335-0473-2)
ndc11
7133504733
60 TABLET in 1 BOTTLE (71335-0473-3)
ndc11
7133504734
100 TABLET in 1 BOTTLE (71335-0473-4)
ndc11
7133504735
180 TABLET in 1 BOTTLE (71335-0473-5)
ndc11
7133504736
120 TABLET in 1 BOTTLE (71335-0473-6)
ndc11
7133504737
10 TABLET in 1 BOTTLE (71335-0473-7)
ndc11
7133504738
500 TABLET in 1 BOTTLE (71335-0473-8)
ndc11
7133504739
1000 TABLET in 1 BOTTLE (71335-0473-9)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A077073

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": "71335-0473_422f8bd0-f200-4715-8c6d-ed6282eec810",
  "productndc": "71335-0473",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "077073",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Sep 26, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Sep 26, 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": "ANDA077073",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMLODIPINE BESYLATE",
  "start_marketing_date": "20070926",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code C08CA01.

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