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United States · US · US:0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931
Xiidra
Orange BookUNIISPLATC S01XA25
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeS01XA25
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11007809111212 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE
- ndc1100780911944 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .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": "0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931",
"productndc": "0078-0911",
"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": "20160711",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code S01XA25.
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