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United States · US · US:0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489
Restasis MultiDose
Orange BookUNIISPLATC S01XA18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
N050790
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "83HN0GTJ6D",
"rxcui": "3008",
"inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
"display_name": "CYCLOSPORINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"7224d810-bb96-4682-a942-3355e6e8061a": {
"match": "brand_token",
"title": "RESTASIS MULTIDOSE (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]",
"spl_version": "15",
"published_date": "2025-09-05"
}
},
"productid": "0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489",
"productndc": "0023-5301",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "050790",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Dec 23, 2002"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.05%",
"product_no": "002",
"approval_date": "Oct 27, 2016"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOSPORINE",
"proprietary_name": "Restasis MultiDose",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050790",
"marketing_category": "NDA",
"nonproprietary_name": "cyclosporine",
"start_marketing_date": "20161110",
"active_numerator_strength": ".5"
}Related drugs
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