Temozolomide

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6516280514
1 BOTTLE in 1 CARTON (65162-805-14) / 14 CAPSULE in 1 BOTTLE
ndc11
6516280551
1 BOTTLE in 1 CARTON (65162-805-51) / 5 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

A203691

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": "65162-805_7cf62d84-45c0-405c-975b-3dbcbcf5ee27",
  "productndc": "65162-805",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203691",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "004",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "May 8, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "May 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "Temozolomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temozolomide",
  "start_marketing_date": "20150403",
  "active_numerator_strength": "180"
}

Related drugs

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