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United States · US · US:62332-060_55b443a9-6652-4408-a91d-7aa4dbc457f9

CANDESARTAN CILEXETIL

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC09CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6233206010
    100 TABLET in 1 CARTON (62332-060-10)
  • ndc11
    6233206030
    30 TABLET in 1 BOTTLE (62332-060-30)
  • ndc11
    6233206090
    90 TABLET in 1 BOTTLE (62332-060-90)

Annotations

UNII (FDA Substance ID)
R85M2X0D68
CANDESARTAN CILEXETIL
RxCUI 135481
Orange Book
A209119
AB
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": "62332-060_55b443a9-6652-4408-a91d-7aa4dbc457f9",
  "productndc": "62332-060",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209119",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL",
  "proprietary_name": "CANDESARTAN CILEXETIL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209119",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CANDESARTAN CILEXETIL",
  "start_marketing_date": "20170621",
  "active_numerator_strength": "32"
}

Related drugs

Other records sharing ATC code C09CA.

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