Warfarin Sodium

Orange BookUNIISPLATC B01AA03

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeB01AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6878873581
100 TABLET in 1 BOTTLE (68788-7358-1)
ndc11
6878873583
30 TABLET in 1 BOTTLE (68788-7358-3)
ndc11
6878873586
60 TABLET in 1 BOTTLE (68788-7358-6)
ndc11
6878873589
90 TABLET in 1 BOTTLE (68788-7358-9)

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": "68788-7358_510d1a24-563c-4e63-807f-c031fe44e39f",
  "productndc": "68788-7358",
  "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 sodium",
  "start_marketing_date": "20111111",
  "active_numerator_strength": "4"
}

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