Dolobid

Orange BookUNIISPLATC N02BA11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerINA Pharmaceutics Inc

CountryUS (United States)

ATC codeN02BA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7415710160
60 TABLET, FILM COATED in 1 BOTTLE (74157-101-60)

Annotations

UNII (FDA Substance ID)

7C546U4DEN

DIFLUNISAL

RxCUI 3393

Orange Book

A202845

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": {
    "725234b2-0e23-45c3-a42d-eb4e62273f9b": {
      "match": "brand_token",
      "title": "DOLOBID (DIFLUNISAL) TABLET, FILM COATED [INA PHARMACEUTICS INC]",
      "spl_version": "4",
      "published_date": "2025-11-17"
    }
  },
  "productid": "74157-101_4081e337-1003-6e39-e063-6294a90a4698",
  "productndc": "74157-101",
  "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": "Dolobid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202845",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diflunisal",
  "start_marketing_date": "20240819",
  "active_numerator_strength": "375"
}

Related drugs

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