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United States · US · US:14539-673_0f1ed721-7842-4b8e-9f10-cf697531e750

diflunisal

Orange BookUNIISPLATC N02BA11

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN02BA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1453967301
    100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)
  • ndc11
    1453967305
    500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)
  • ndc11
    1453967306
    60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)

Annotations

UNII (FDA Substance ID)
7C546U4DEN
DIFLUNISAL
RxCUI 3393
Orange Book
A202845
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7C546U4DEN",
    "rxcui": "3393",
    "inchikey": "HUPFGZXOMWLGNK-UHFFFAOYSA-N",
    "display_name": "DIFLUNISAL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7a78bb38-14d8-4a90-b883-482d4cebf716": {
      "match": "brand_token",
      "title": "DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "21",
      "published_date": "2024-12-19"
    }
  },
  "productid": "14539-673_0f1ed721-7842-4b8e-9f10-cf697531e750",
  "productndc": "14539-673",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202845",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 8, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Aug 16, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "375MG",
        "product_no": "003",
        "approval_date": "Aug 16, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIFLUNISAL",
  "proprietary_name": "diflunisal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202845",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diflunisal",
  "start_marketing_date": "20120308",
  "active_numerator_strength": "500"
}

Related drugs

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