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United States · US · US:33342-287_1ea4f227-b97a-49f1-bbc3-1dede2c1866d

amlodipine,valsartan and hydrochlorothiazide

In shortageOrange BookUNIISPLATC C08CA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeC08CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3334228707
    30 TABLET, FILM COATED in 1 BOTTLE (33342-287-07)
  • ndc11
    3334228710
    90 TABLET, FILM COATED in 1 BOTTLE (33342-287-10)
  • ndc11
    3334228712
    10 BLISTER PACK in 1 CARTON (33342-287-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
864V2Q084H
AMLODIPINE BESYLATE
RxCUI 104416
Orange Book
A207299
ABABABABAB
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": {
    "1ea4f227-b97a-49f1-bbc3-1dede2c1866d": {
      "match": "brand_token",
      "title": "AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "1",
      "published_date": "2025-01-13"
    }
  },
  "productid": "33342-287_1ea4f227-b97a-49f1-bbc3-1dede2c1866d",
  "productndc": "33342-287",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207299",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;12.5MG;160MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE;25MG;160MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;12.5MG;160MG",
        "product_no": "003",
        "approval_date": "Jan 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;160MG",
        "product_no": "004",
        "approval_date": "Jan 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE;25MG;320MG",
        "product_no": "005",
        "approval_date": "Jan 7, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN",
  "shortage_reason": "Amlodipine Besylate; Benazepril Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "amlodipine,valsartan and hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA207299",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amlodipine,valsartan and hydrochlorothiazide",
  "start_marketing_date": "20250106",
  "active_numerator_strength": "10; 25; 320"
}

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