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United States · US · US:24208-911_2770cd53-f66c-2097-e063-6394a90a874b

Xiidra

Orange BookUNIISPLATC S01XA25

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01XA25
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420891112
    12 POUCH in 1 CARTON (24208-911-12) / 5 AMPULE in 1 POUCH (24208-911-05) / .2 mL in 1 AMPULE
  • ndc11
    2420891194
    4 POUCH in 1 CARTON (24208-911-94) / 5 AMPULE in 1 POUCH (24208-911-95) / .2 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
038E5L962W
LIFITEGRAST
RxCUI 1801820
Orange Book
N208073
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "038E5L962W",
    "rxcui": "1801820",
    "inchikey": "JFOZKMSJYSPYLN-QHCPKHFHSA-N",
    "display_name": "LIFITEGRAST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "8589d376-ac10-4ddb-9c53-2e0c8d5675c4": {
      "match": "brand_token",
      "title": "XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "6",
      "published_date": "2025-08-20"
    }
  },
  "productid": "24208-911_2770cd53-f66c-2097-e063-6394a90a874b",
  "productndc": "24208-911",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "208073",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Jul 11, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIFITEGRAST",
  "proprietary_name": "Xiidra",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA208073",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lifitegrast",
  "start_marketing_date": "20240102",
  "active_numerator_strength": "50"
}

Related drugs

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