Amlodipine Besylate and Benazepril Hydrochloride

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeC08CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923826871
100 CAPSULE in 1 BOTTLE (69238-2687-1)

Annotations

UNII (FDA Substance ID)

864V2Q084H

AMLODIPINE BESYLATE

RxCUI 104416

Orange Book

A077215

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": "69238-2687_9c78bd64-01e2-4597-838a-947cdaba7ba2",
  "productndc": "69238-2687",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077215",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2.5MG BASE;10MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;10MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "004",
        "approval_date": "Dec 7, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine Besylate and Benazepril Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA077215",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine Besylate and Benazepril Hydrochloride",
  "start_marketing_date": "20260414",
  "active_numerator_strength": "10; 20"
}

Related drugs

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