Warfarin Sodium

Orange BookUNIISPLATC B01AA03

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeB01AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4335305330
30 TABLET in 1 BOTTLE (43353-053-30)

Annotations

UNII (FDA Substance ID)

6153CWM0CL

WARFARIN SODIUM

RxCUI 114194

Orange Book

A090935

ABABABABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6153CWM0CL",
    "rxcui": "114194",
    "inchikey": "KYITYFHKDODNCQ-UHFFFAOYSA-M",
    "display_name": "WARFARIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52bacf1e-9ba8-7eca-e063-6394a90ab60b": {
      "match": "brand_token",
      "title": "WARFARIN SODIUM (WARFARIN) TABLET [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "43353-053_49001c15-cda7-00e5-e063-6394a90a0853",
  "productndc": "43353-053",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090935",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "003",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "004",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "005",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "006",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "007",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "008",
        "approval_date": "May 25, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "009",
        "approval_date": "May 25, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "WARFARIN SODIUM",
  "proprietary_name": "Warfarin Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090935",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Warfarin",
  "start_marketing_date": "20150408",
  "active_numerator_strength": "7.5"
}

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