candesartan cilexetil and hydrochlorothiazide

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerSolco Healthcare LLC

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4354746009
90 TABLET in 1 BOTTLE (43547-460-09)
ndc11
4354746050
500 TABLET in 1 BOTTLE (43547-460-50)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A207455

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": "43547-460_745438ab-c3fe-4da9-9548-730970399e0d",
  "productndc": "43547-460",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207455",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG;12.5MG",
        "product_no": "001",
        "approval_date": "Apr 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;12.5MG",
        "product_no": "002",
        "approval_date": "Apr 11, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;25MG",
        "product_no": "003",
        "approval_date": "Apr 11, 2018"
      }
    ],
    "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": "ANDA207455",
  "marketing_category": "ANDA",
  "nonproprietary_name": "candesartan cilexetil and hydrochlorothiazide",
  "start_marketing_date": "20171120",
  "active_numerator_strength": "32; 12.5"
}

Related drugs

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