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United States · US · US:68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80

Diflunisal

Orange BookUNIISPLATC N02BA11

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

Identification

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

Packs · 7

  • ndc11
    6838253001
    100 TABLET in 1 BOTTLE (68382-530-01)
  • ndc11
    6838253005
    500 TABLET in 1 BOTTLE (68382-530-05)
  • ndc11
    6838253006
    30 TABLET in 1 BOTTLE (68382-530-06)
  • ndc11
    6838253010
    1000 TABLET in 1 BOTTLE (68382-530-10)
  • ndc11
    6838253014
    60 TABLET in 1 BOTTLE (68382-530-14)
  • ndc11
    6838253016
    90 TABLET in 1 BOTTLE (68382-530-16)
  • ndc11
    6838253030
    10 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
7C546U4DEN
DIFLUNISAL
RxCUI 3393
Orange Book
A203547
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": "68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80",
  "productndc": "68382-530",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203547",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIFLUNISAL",
  "proprietary_name": "Diflunisal",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diflunisal",
  "start_marketing_date": "20170914",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code N02BA11.

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