LENALIDOMIDE

Orange BookUNIISPLATC L04AX04

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

Identification

ManufacturerAlvogen, Inc.

CountryUS (United States)

ATC codeL04AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4778148301
100 CAPSULE in 1 BOTTLE (47781-483-01)
ndc11
4778148328
28 CAPSULE in 1 BOTTLE (47781-483-28)

Annotations

UNII (FDA Substance ID)

F0P408N6V4

LENALIDOMIDE

RxCUI 342369

Orange Book

A210480

ABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F0P408N6V4",
    "rxcui": "342369",
    "inchikey": "GOTYRUGSSMKFNF-UHFFFAOYSA-N",
    "display_name": "LENALIDOMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "da7b5dda-79ed-4c4a-88aa-52394fdc7c54": {
      "match": "brand_token",
      "title": "LENALIDOMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "6",
      "published_date": "2026-05-20"
    }
  },
  "productid": "47781-483_1c3e5289-7ff0-54c1-9146-f7ec3f49aea2",
  "productndc": "47781-483",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210480",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Aug 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Aug 31, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "005",
        "approval_date": "Mar 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Mar 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENALIDOMIDE",
  "proprietary_name": "LENALIDOMIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210480",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lenalidomide",
  "start_marketing_date": "20230306",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX04.

Access this data programmatically

Query LENALIDOMIDE 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