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United States · US · US:68180-214_3dade5e6-5243-42a1-b1fa-0fb094e8da5f
CYCLOSPORINE
Orange BookUNIISPLATC S01XA18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11681802143030 VIAL, SINGLE-USE in 1 TRAY (68180-214-30) / .4 mL in 1 VIAL, SINGLE-USE
- ndc11681802146060 VIAL, SINGLE-USE in 1 TRAY (68180-214-60) / .4 mL in 1 VIAL, SINGLE-USE
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": {
"f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850": {
"match": "brand_token",
"title": "CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "2",
"published_date": "2026-05-25"
}
},
"productid": "68180-214_3dade5e6-5243-42a1-b1fa-0fb094e8da5f",
"productndc": "68180-214",
"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": "CYCLOSPORINE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050790",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "cyclosporine",
"start_marketing_date": "20220511",
"active_numerator_strength": ".5"
}Related drugs
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- FICequaSun Pharmaceutical Industries Europe B.V.
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