Pomalidomide

Orange BookUNIISPLATC L04AX06

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.

CountryUS (United States)

ATC codeL04AX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5199134621
21 CAPSULE in 1 BOTTLE, PLASTIC (51991-346-21)

Annotations

UNII (FDA Substance ID)

D2UX06XLB5

POMALIDOMIDE

RxCUI 1369713

Orange Book

A210111

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": "51991-346_44621941-eb2e-421f-bcf0-ed39d4de70f4",
  "productndc": "51991-346",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210111",
    "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": "ANDA210111",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pomalidomide",
  "start_marketing_date": "20260228",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code L04AX06.

Access this data programmatically

Query Pomalidomide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs