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United States · US · US:59572-504_4410582a-a5f3-429f-a7ca-5c17fb5560bf

Pomalyst

Orange BookUNIISPLATC L04AX06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCelgene Corporation
CountryUS (United States)
ATC codeL04AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5957250400
    100 CAPSULE in 1 BOTTLE (59572-504-00)
  • ndc11
    5957250421
    21 CAPSULE in 1 BOTTLE (59572-504-21)

Annotations

UNII (FDA Substance ID)
D2UX06XLB5
POMALIDOMIDE
RxCUI 1369713
Orange Book
N204026
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "D2UX06XLB5",
    "rxcui": "1369713",
    "inchikey": "UVSMNLNDYGZFPF-UHFFFAOYSA-N",
    "display_name": "POMALIDOMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2b25ef01-5c9e-11e1-b86c-0800200c9a66": {
      "match": "brand_token",
      "title": "POMALYST (POMALIDOMIDE) CAPSULE [CELGENE CORPORATION]",
      "spl_version": "26",
      "published_date": "2025-05-12"
    }
  },
  "productid": "59572-504_4410582a-a5f3-429f-a7ca-5c17fb5560bf",
  "productndc": "59572-504",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204026",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Feb 8, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Feb 8, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Feb 8, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Feb 8, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POMALIDOMIDE",
  "proprietary_name": "Pomalyst",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204026",
  "marketing_category": "NDA",
  "nonproprietary_name": "pomalidomide",
  "start_marketing_date": "20130218",
  "active_numerator_strength": "4"
}

Related drugs

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