LANOXIN

Orange BookUNIISPLATC C01AA05

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

Identification

ManufacturerAdvanz Pharma (US) Corp.

CountryUS (United States)

ATC codeC01AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5921224055
100 TABLET in 1 BOTTLE (59212-240-55)

Annotations

UNII (FDA Substance ID)

73K4184T59

DIGOXIN

RxCUI 3407

Orange Book

N020405

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "73K4184T59",
    "rxcui": "3407",
    "inchikey": "LTMHDMANZUZIPE-PUGKRICDSA-N",
    "display_name": "DIGOXIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9ec84cac-6ecc-43dc-8006-6ccc029e2707": {
      "match": "brand_token",
      "title": "LANOXIN (DIGOXIN) INJECTION, SOLUTION [COVIS PHARMA US, INC]",
      "spl_version": "10",
      "published_date": "2025-11-17"
    }
  },
  "productid": "59212-240_3a39029f-2e63-4894-8a0d-45e122f5047b",
  "productndc": "59212-240",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020405",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.0625MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.125MG",
        "product_no": "002",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.1875MG",
        "product_no": "003",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "004",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.375MG",
        "product_no": "005",
        "approval_date": "Sep 30, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "006",
        "approval_date": "Sep 30, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIGOXIN",
  "proprietary_name": "LANOXIN",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020405",
  "marketing_category": "NDA",
  "nonproprietary_name": "digoxin",
  "start_marketing_date": "20120930",
  "active_numerator_strength": ".0625"
}

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