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United States · US · US:0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e

Diflunisal

Orange BookUNIISPLATC N02BA11

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN02BA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0093922201
    100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01)
  • ndc11
    0093922205
    500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05)
  • ndc11
    0093922206
    60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06)

Annotations

UNII (FDA Substance ID)
7C546U4DEN
DIFLUNISAL
RxCUI 3393
Orange Book
A073673
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": "0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e",
  "productndc": "0093-9222",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "073673",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jul 31, 1992"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIFLUNISAL",
  "proprietary_name": "Diflunisal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA073673",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diflunisal",
  "start_marketing_date": "20210630",
  "active_numerator_strength": "500"
}

Related drugs

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