Candesartan Cilexetil and Hydrochlorothiazide

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378300377
90 TABLET in 1 BOTTLE, PLASTIC (0378-3003-77)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A090704

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": "0378-3003_b308024b-d9c2-4b12-ac28-cb2e295ab1bf",
  "productndc": "0378-3003",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090704",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG;12.5MG",
        "product_no": "001",
        "approval_date": "Dec 4, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;12.5MG",
        "product_no": "002",
        "approval_date": "Dec 4, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG;25MG",
        "product_no": "003",
        "approval_date": "Dec 4, 2012"
      }
    ],
    "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": "ANDA090704",
  "marketing_category": "ANDA",
  "nonproprietary_name": "candesartan cilexetil and hydrochlorothiazide",
  "start_marketing_date": "20121204",
  "active_numerator_strength": "32; 25"
}

Related drugs

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