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United States · US · US:59651-197_1539fbf9-8281-4c7b-827b-9f53b50d9042

Pomalidomide

Orange BookUNIISPLATC L04AX06

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeL04AX06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965119701
    100 CAPSULE in 1 BOTTLE (59651-197-01)
  • ndc11
    5965119721
    21 CAPSULE in 1 BOTTLE (59651-197-21)

Annotations

UNII (FDA Substance ID)
D2UX06XLB5
POMALIDOMIDE
RxCUI 1369713
Orange Book
A210249
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": {
    "41400b90-b64e-447b-90f3-1cad58050eba": {
      "match": "brand_token",
      "title": "POMALIDOMIDE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]",
      "spl_version": "10",
      "published_date": "2026-03-18"
    }
  },
  "productid": "59651-197_1539fbf9-8281-4c7b-827b-9f53b50d9042",
  "productndc": "59651-197",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210249",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Oct 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Oct 30, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POMALIDOMIDE",
  "proprietary_name": "Pomalidomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210249",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pomalidomide",
  "start_marketing_date": "20201030",
  "active_numerator_strength": "4"
}

Related drugs

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