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United States · US · US:70518-4634_5073dc36-16d3-94e3-e063-6294a90ad902

Warfarin Sodium

Orange BookUNIISPLATC B01AA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeB01AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051846340
    50 POUCH in 1 BOX (70518-4634-0) / 1 TABLET in 1 POUCH (70518-4634-1)

Annotations

UNII (FDA Substance ID)
6153CWM0CL
WARFARIN SODIUM
RxCUI 114194
Orange Book
A040301
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": "70518-4634_5073dc36-16d3-94e3-e063-6294a90ad902",
  "productndc": "70518-4634",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040301",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "004",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "005",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "006",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "007",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "008",
        "approval_date": "Jul 15, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "009",
        "approval_date": "Jul 15, 1999"
      }
    ],
    "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": "ANDA040301",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Warfarin Sodium",
  "start_marketing_date": "20260426",
  "active_numerator_strength": "2.5"
}

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