ATACAND

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 · 2

ndc11
6255964230
30 TABLET in 1 BOTTLE (62559-642-30)
ndc11
6255964290
90 TABLET in 1 BOTTLE (62559-642-90)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

N020838

ABABABAB

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": "62559-642_6ae461eb-f06a-4bf1-b6da-73d66b99b33c",
  "productndc": "62559-642",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020838",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Jun 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Jun 4, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Jun 4, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "004",
        "approval_date": "Jun 4, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL",
  "proprietary_name": "ATACAND",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020838",
  "marketing_category": "NDA",
  "nonproprietary_name": "Candesartan Cilexetil",
  "start_marketing_date": "20181001",
  "active_numerator_strength": "16"
}

Related drugs

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