Temozolomide

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerDevatis, Inc.

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7304301605
5 CAPSULE in 1 BOTTLE (73043-016-05)

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

A207658

ABABABABABAB

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": {
    "28fae355-e29a-4f76-9c83-bc44663ff7d4": {
      "match": "brand_token",
      "title": "TEMOZOLOMIDE CAPSULE [OPKO PHARMACEUTICALS, LLC]",
      "spl_version": "1",
      "published_date": "2026-05-12"
    }
  },
  "productid": "73043-016_d6ae8576-1b18-45d5-b651-cc290d979032",
  "productndc": "73043-016",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207658",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "004",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Apr 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Apr 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "Temozolomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207658",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temozolomide",
  "start_marketing_date": "20170428",
  "active_numerator_strength": "250"
}

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