candesartan cilexetil and hydrochlorothiazide

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7077113270
1000 TABLET in 1 BOTTLE (70771-1327-0)
ndc11
7077113271
100 TABLET in 1 BOTTLE (70771-1327-1)
ndc11
7077113273
30 TABLET in 1 BOTTLE (70771-1327-3)
ndc11
7077113274
10 BLISTER PACK in 1 CARTON (70771-1327-4) / 10 TABLET in 1 BLISTER PACK (70771-1327-2)
ndc11
7077113279
90 TABLET in 1 BOTTLE (70771-1327-9)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A203466

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R85M2X0D68",
    "rxcui": "135481",
    "inchikey": "GHOSNRCGJFBJIB-UHFFFAOYSA-N",
    "display_name": "CANDESARTAN CILEXETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "76630807-9717-44be-946d-756038cf677e": {
      "match": "brand_token",
      "title": "CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]",
      "spl_version": "9",
      "published_date": "2026-04-21"
    }
  },
  "productid": "70771-1327_2b38d778-d732-4a7b-bb34-b426a14e10bc",
  "productndc": "70771-1327",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203466",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG;12.5MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;12.5MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;25MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "candesartan cilexetil and hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203466",
  "marketing_category": "ANDA",
  "nonproprietary_name": "candesartan cilexetil and hydrochlorothiazide",
  "start_marketing_date": "20180414",
  "active_numerator_strength": "32; 25"
}

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