Lenalidomide

Orange BookUNIISPLATC L04AX04

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeL04AX04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6330404101
100 CAPSULE in 1 BOTTLE (63304-041-01)
ndc11
6330404127
28 CAPSULE in 1 BOTTLE (63304-041-27)

Annotations

UNII (FDA Substance ID)

F0P408N6V4

LENALIDOMIDE

RxCUI 342369

Orange Book

A211846

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": "63304-041_2922537e-47de-b6b9-e063-6294a90a0f19",
  "productndc": "63304-041",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211846",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Feb 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Feb 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Feb 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "004",
        "approval_date": "Feb 8, 2023"
      },
      {
        "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": "ANDA211846",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lenalidomide",
  "start_marketing_date": "20230312",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code L04AX04.

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