Candesartan Cilexetil and Hydrochlorothiazide

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334213310
90 TABLET in 1 BOTTLE (33342-133-10)
ndc11
3334213312
10 BLISTER PACK in 1 CARTON (33342-133-12) / 10 TABLET in 1 BLISTER PACK
ndc11
3334213315
500 TABLET in 1 BOTTLE (33342-133-15)
ndc11
3334213351
300 TABLET in 1 BOTTLE (33342-133-51)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A204100

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": "33342-133_07873250-a90d-4e06-bfa8-a4202794791d",
  "productndc": "33342-133",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204100",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG;12.5MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;12.5MG",
        "product_no": "002",
        "approval_date": "Feb 27, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;25MG",
        "product_no": "003",
        "approval_date": "Feb 27, 2015"
      }
    ],
    "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": "ANDA204100",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Candesartan Cilexetil and Hydrochlorothiazide",
  "start_marketing_date": "20150307",
  "active_numerator_strength": "32; 25"
}

Related drugs

Other records sharing ATC code C09CA.

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