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United States · US · US:71085-082_3b2b98e9-9358-52c6-e063-6394a90a3758

LURBIRO

Orange BookUNIISPLATC M02AA19

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

Identification

ManufacturerIPG Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM02AA19
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7108508230
    30 TABLET in 1 BOTTLE (71085-082-30)

Annotations

UNII (FDA Substance ID)
5GRO578KLP
FLURBIPROFEN
RxCUI 4502
Orange Book
A074431
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5GRO578KLP",
    "rxcui": "4502",
    "inchikey": "SYTBZMRGLBWNTM-UHFFFAOYSA-N",
    "display_name": "FLURBIPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7ebf7427-eaae-4035-a6b2-0ea6381e8763": {
      "match": "brand_token",
      "title": "LURBIRO (FLURBIPROFEN) TABLET [IPG PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-08-04"
    }
  },
  "productid": "71085-082_3b2b98e9-9358-52c6-e063-6394a90a3758",
  "productndc": "71085-082",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074431",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 31, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLURBIPROFEN",
  "proprietary_name": "LURBIRO",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074431",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flurbiprofen",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "100"
}

Related drugs

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