ATACAND HCT

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6255965090
90 TABLET in 1 BOTTLE (62559-650-90)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

N021093

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": {
    "94a59260-d2b6-464a-b5b9-bbc599e57e10": {
      "match": "brand_token",
      "title": "ATACAND (CANDESARTAN CILEXETIL) TABLET [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "5",
      "published_date": "2025-12-23"
    }
  },
  "productid": "62559-650_512f014c-894d-43ff-96a6-1ff05bc476e6",
  "productndc": "62559-650",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021093",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "16MG;12.5MG",
        "product_no": "001",
        "approval_date": "Sep 5, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "32MG;12.5MG",
        "product_no": "002",
        "approval_date": "Sep 5, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "32MG;25MG",
        "product_no": "003",
        "approval_date": "May 16, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
  "proprietary_name": "ATACAND HCT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021093",
  "marketing_category": "NDA",
  "nonproprietary_name": "Candesartan Cilexetil and Hydrochlorothiazide",
  "start_marketing_date": "20181001",
  "active_numerator_strength": "16; 12.5"
}

Related drugs

Other records sharing ATC code C09CA.

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