LANOXIN

Orange BookUNIISPLATC C01AA05

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC01AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161001960
90 TABLET in 1 BOTTLE (71610-019-60)

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": "71610-019_1d7755ac-5480-4614-bc20-beb024ab95f2",
  "productndc": "71610-019",
  "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": ".125"
}

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