TEMOZOLOMIDE

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1657182002
20 CAPSULE in 1 BOTTLE (16571-820-02)
ndc11
1657182041
14 CAPSULE in 1 BOTTLE (16571-820-41)
ndc11
1657182051
5 CAPSULE in 1 BOTTLE (16571-820-51)

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

A206309

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": "16571-820_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5",
  "productndc": "16571-820",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206309",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Apr 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "004",
        "approval_date": "Apr 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Apr 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Apr 27, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "TEMOZOLOMIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206309",
  "marketing_category": "ANDA",
  "nonproprietary_name": "temozolomide",
  "start_marketing_date": "20221004",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code L01AX03.

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