Pomalidomide

Orange BookUNIISPLATC L04AX06

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeL04AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050545002
21 CAPSULE in 1 BOTTLE (60505-4500-2)

Annotations

UNII (FDA Substance ID)

D2UX06XLB5

POMALIDOMIDE

RxCUI 1369713

Orange Book

A210164

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": "60505-4500_79028ff4-3130-88ed-e3fc-18a7d9a779b8",
  "productndc": "60505-4500",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210164",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jun 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Jun 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "Jun 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "Jun 11, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POMALIDOMIDE",
  "proprietary_name": "Pomalidomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210164",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pomalidomide",
  "start_marketing_date": "20260311",
  "active_numerator_strength": "4"
}

Related drugs

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