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United States · US · US:55111-338_6fafdf6a-6153-9a62-1774-755f2bcf0cc2

Amlodipine Besylate and Benazepril Hydrochloride

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5511133801
    100 CAPSULE in 1 BOTTLE (55111-338-01)
  • ndc11
    5511133805
    500 CAPSULE in 1 BOTTLE (55111-338-05)
  • ndc11
    5511133830
    30 CAPSULE in 1 BOTTLE (55111-338-30)

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A077183
ABABABAB
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": "55111-338_6fafdf6a-6153-9a62-1774-755f2bcf0cc2",
  "productndc": "55111-338",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE;10MG",
        "product_no": "001",
        "approval_date": "Apr 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;10MG",
        "product_no": "002",
        "approval_date": "Apr 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;20MG",
        "product_no": "003",
        "approval_date": "Apr 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;20MG",
        "product_no": "004",
        "approval_date": "Apr 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
  "shortage_reason": "Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amlodipine Besylate and Benazepril Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA077183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amlodipine Besylate and Benazepril Hydrochloride",
  "start_marketing_date": "20100419",
  "active_numerator_strength": "2.5; 10"
}

Related drugs

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