Candesartan

Orange BookUNIISPLATC C09CA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC09CA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334211607
30 TABLET in 1 CONTAINER (33342-116-07)
ndc11
3334211610
90 TABLET in 1 CONTAINER (33342-116-10)
ndc11
3334211612
10 BLISTER PACK in 1 CARTON (33342-116-12) / 10 TABLET in 1 BLISTER PACK
ndc11
3334211651
300 TABLET in 1 CONTAINER (33342-116-51)

Annotations

UNII (FDA Substance ID)

R85M2X0D68

CANDESARTAN CILEXETIL

RxCUI 135481

Orange Book

A203813

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": {
    "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": "33342-116_4079c843-42ee-4f7a-a4a0-9498ba6cf12d",
  "productndc": "33342-116",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203813",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 5, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Dec 5, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Dec 5, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "004",
        "approval_date": "Dec 5, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANDESARTAN CILEXETIL",
  "proprietary_name": "Candesartan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203813",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Candesartan",
  "start_marketing_date": "20161206",
  "active_numerator_strength": "16"
}

Related drugs

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