temozolomide

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerNivagen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7583414505
1 CARTON in 1 CARTON (75834-145-05) / 5 CAPSULE in 1 CARTON
ndc11
7583414514
1 CARTON in 1 CARTON (75834-145-14) / 14 CAPSULE in 1 CARTON

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

A213328

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": "75834-145_9db23336-458a-46a6-a676-1702497a1891",
  "productndc": "75834-145",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213328",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "140MG",
        "product_no": "004",
        "approval_date": "Nov 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Nov 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Nov 23, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "temozolomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213328",
  "marketing_category": "ANDA",
  "nonproprietary_name": "temozolomide",
  "start_marketing_date": "20211207",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code L01AX03.

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