Temozolomide

Orange BookUNIISPLATC L01AX03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeL01AX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4733589221
1 BOTTLE in 1 CARTON (47335-892-21) / 14 CAPSULE in 1 BOTTLE
ndc11
4733589272
15 BLISTER PACK in 1 CARTON (47335-892-72) / 1 CAPSULE in 1 BLISTER PACK
ndc11
4733589274
5 BLISTER PACK in 1 CARTON (47335-892-74) / 1 CAPSULE in 1 BLISTER PACK
ndc11
4733589275
20 BLISTER PACK in 1 CARTON (47335-892-75) / 1 CAPSULE in 1 BLISTER PACK
ndc11
4733589280
1 BOTTLE in 1 CARTON (47335-892-80) / 5 CAPSULE in 1 BOTTLE
ndc11
4733589287
1 BOTTLE in 1 CARTON (47335-892-87) / 20 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

YF1K15M17Y

TEMOZOLOMIDE

RxCUI 37776

Orange Book

A201742

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": "47335-892_7c774570-443b-40da-8038-7cb550f92048",
  "productndc": "47335-892",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "201742",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Feb 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Feb 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG",
        "product_no": "004",
        "approval_date": "Feb 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Feb 12, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "006",
        "approval_date": "Feb 12, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMOZOLOMIDE",
  "proprietary_name": "Temozolomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201742",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temozolomide",
  "start_marketing_date": "20140213",
  "active_numerator_strength": "100"
}

Related drugs

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