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United States · US · US:70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139

Diflunisal

Orange BookUNIISPLATC N02BA11

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN02BA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7077110830
    1000 TABLET in 1 BOTTLE (70771-1083-0)
  • ndc11
    7077110831
    100 TABLET in 1 BOTTLE (70771-1083-1)
  • ndc11
    7077110833
    30 TABLET in 1 BOTTLE (70771-1083-3)
  • ndc11
    7077110835
    500 TABLET in 1 BOTTLE (70771-1083-5)
  • ndc11
    7077110836
    60 TABLET in 1 BOTTLE (70771-1083-6)
  • ndc11
    7077110838
    10 BLISTER PACK in 1 CARTON (70771-1083-8) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    7077110839
    90 TABLET in 1 BOTTLE (70771-1083-9)

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": "70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139",
  "productndc": "70771-1083",
  "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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