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United States · US · US:71205-599_c2c51ec3-ffb0-4240-b048-a8e424775a76

Amlodipine Besylate

In shortageOrange BookUNIISPLATC C08CA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC08CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7120559930
    30 TABLET in 1 BOTTLE, PLASTIC (71205-599-30)
  • ndc11
    7120559960
    60 TABLET in 1 BOTTLE, PLASTIC (71205-599-60)
  • ndc11
    7120559990
    90 TABLET in 1 BOTTLE, PLASTIC (71205-599-90)

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; Benazepril Hydrochloride Capsule
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": "71205-599_c2c51ec3-ffb0-4240-b048-a8e424775a76",
  "productndc": "71205-599",
  "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; Benazepril Hydrochloride Capsule",
  "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

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