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
6255964330
30 TABLET in 1 BOTTLE (62559-643-30)
ndc11
6255964390
90 TABLET in 1 BOTTLE (62559-643-90)

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": "62559-643_6ae461eb-f06a-4bf1-b6da-73d66b99b33c",
  "productndc": "62559-643",
  "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": "32"
}

Related drugs

Other records sharing ATC code C09CA.

Access this data programmatically

Query ATACAND and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs