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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
- ndc11596514506060 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
Other records sharing ATC code S01XA25.
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