Lenalidomide

Orange BookUNIISPLATC L04AX04

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

Identification

ManufacturerAccord Healthcare Inc.

CountryUS (United States)

ATC codeL04AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672969606
21 CAPSULE in 1 BOTTLE (16729-696-06)

Annotations

UNII (FDA Substance ID)

F0P408N6V4

LENALIDOMIDE

RxCUI 342369

Orange Book

A218872

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": "16729-696_513e8d33-e9bf-df2b-e063-6394a90a1ee9",
  "productndc": "16729-696",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218872",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "004",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "005",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "006",
        "approval_date": "Nov 14, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LENALIDOMIDE",
  "proprietary_name": "Lenalidomide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218872",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lenalidomide",
  "start_marketing_date": "20260226",
  "active_numerator_strength": "20"
}

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