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United States · US · US:59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400

Lifitegrast

Orange BookUNIISPLATC S01XA25

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeS01XA25
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965145060
    60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)
038E5L962W
LIFITEGRAST
RxCUI 1801820
Orange Book
A215063
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": {
    "1d4b4b61-79da-4b6f-bb19-056d111bf400": {
      "match": "brand_token",
      "title": "LIFITEGRAST FOR SOLUTION [AUROBINDO PHARMA LIMITED]",
      "spl_version": "1",
      "published_date": "2023-11-15"
    }
  },
  "productid": "59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400",
  "productndc": "59651-450",
  "dosage_form": "FOR SOLUTION",
  "orange_book": {
    "appl_no": "215063",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5%",
        "product_no": "001",
        "approval_date": "Nov 7, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LIFITEGRAST",
  "proprietary_name": "Lifitegrast",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215063",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lifitegrast",
  "start_marketing_date": "20231107",
  "active_numerator_strength": "50"
}

Related drugs

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