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 · 25

ndc11
4335302311
48 TABLET in 1 BOTTLE (43353-023-11)
ndc11
4335302315
15 TABLET in 1 BOTTLE (43353-023-15)
ndc11
4335302320
20 TABLET in 1 BOTTLE (43353-023-20)
ndc11
4335302321
32 TABLET in 1 BOTTLE (43353-023-21)
ndc11
4335302325
25 TABLET in 1 BOTTLE (43353-023-25)
ndc11
4335302328
28 TABLET in 1 BOTTLE (43353-023-28)
ndc11
4335302330
30 TABLET in 1 BOTTLE (43353-023-30)
ndc11
4335302335
35 TABLET in 1 BOTTLE (43353-023-35)
ndc11
4335302338
55 TABLET in 1 BOTTLE (43353-023-38)
ndc11
4335302340
40 TABLET in 1 BOTTLE (43353-023-40)
ndc11
4335302344
36 TABLET in 1 BOTTLE (43353-023-44)
ndc11
4335302345
45 TABLET in 1 BOTTLE (43353-023-45)
ndc11
4335302346
56 TABLET in 1 BOTTLE (43353-023-46)
ndc11
4335302347
24 TABLET in 1 BOTTLE (43353-023-47)
ndc11
4335302350
50 TABLET in 1 BOTTLE (43353-023-50)
ndc11
4335302353
60 TABLET in 1 BOTTLE (43353-023-53)
ndc11
4335302355
75 TABLET in 1 BOTTLE (43353-023-55)
ndc11
4335302357
80 TABLET in 1 BOTTLE (43353-023-57)
ndc11
4335302359
22 TABLET in 1 BOTTLE (43353-023-59)
ndc11
4335302360
90 TABLET in 1 BOTTLE (43353-023-60)
ndc11
4335302361
70 TABLET in 1 BOTTLE (43353-023-61)
ndc11
4335302365
100 TABLET in 1 BOTTLE (43353-023-65)
ndc11
4335302368
26 TABLET in 1 BOTTLE (43353-023-68)
ndc11
4335302370
120 TABLET in 1 BOTTLE (43353-023-70)
ndc11
4335302378
34 TABLET in 1 BOTTLE (43353-023-78)

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": "43353-023_49001c15-cda7-00e5-e063-6394a90a0853",
  "productndc": "43353-023",
  "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": "5"
}

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