TEMODAR

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerMerck Sharp & Dohme LLC

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0085143003
5 PACKET in 1 CARTON (0085-1430-03) / 1 CAPSULE in 1 PACKET (0085-1430-05)
ndc11
0085143004
14 PACKET in 1 CARTON (0085-1430-04) / 1 CAPSULE in 1 PACKET (0085-1430-05)

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

N021029

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YF1K15M17Y",
    "rxcui": "37776",
    "inchikey": "BPEGJWRSRHCHSN-UHFFFAOYSA-N",
    "display_name": "TEMOZOLOMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "046a9011-3911-4d3f-a15f-fbb56d5aad56": {
      "match": "brand_token",
      "title": "TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "40",
      "published_date": "2026-03-04"
    }
  },
  "productid": "0085-1430_40ceddc0-83a2-4b3b-8953-fd0078a41133",
  "productndc": "0085-1430",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021029",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "250MG",
        "product_no": "004",
        "approval_date": "Aug 11, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "140MG",
        "product_no": "005",
        "approval_date": "Oct 19, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "180MG",
        "product_no": "006",
        "approval_date": "Oct 19, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "TEMODAR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021029",
  "marketing_category": "NDA",
  "nonproprietary_name": "Temozolomide",
  "start_marketing_date": "19990811",
  "active_numerator_strength": "180"
}

Related drugs

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