Pomalidomide

Orange BookUNIISPLATC L04AX06

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL04AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480260121
21 CAPSULE in 1 BOTTLE (0480-2601-21)

Annotations

UNII (FDA Substance ID)

D2UX06XLB5

POMALIDOMIDE

RxCUI 1369713

Orange Book

A209956

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": "0480-2601_b6e6a69c-e11e-4eb7-9340-4eb92255f400",
  "productndc": "0480-2601",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209956",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "May 4, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "May 4, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "003",
        "approval_date": "May 4, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "004",
        "approval_date": "May 4, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POMALIDOMIDE",
  "proprietary_name": "Pomalidomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209956",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pomalidomide",
  "start_marketing_date": "20260302",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code L04AX06.

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