Lenalidomide

Orange BookUNIISPLATC L04AX04

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeL04AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050545362
21 CAPSULE in 1 BOTTLE (60505-4536-2)

Annotations

UNII (FDA Substance ID)

F0P408N6V4

LENALIDOMIDE

RxCUI 342369

Orange Book

A211022

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": "60505-4536_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4",
  "productndc": "60505-4536",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211022",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "005",
        "approval_date": "Mar 7, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "006",
        "approval_date": "Mar 7, 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": "ANDA211022",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lenalidomide",
  "start_marketing_date": "20230309",
  "active_numerator_strength": "20"
}

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