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United States · US · US:60505-0133_561ed7a8-f342-f4fe-ce36-998d87c33e7f
Cyclosporine
Orange BookUNIISPLATC S01XA18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeS01XA18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11605050133030 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0133-0)
Annotations
UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A065040
AB2AB2
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": "ORAL",
"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": "60505-0133_561ed7a8-f342-f4fe-ce36-998d87c33e7f",
"productndc": "60505-0133",
"dosage_form": "CAPSULE, GELATIN COATED",
"orange_book": {
"appl_no": "065040",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "25MG",
"product_no": "001",
"approval_date": "May 9, 2002"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "100MG",
"product_no": "002",
"approval_date": "May 9, 2002"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOSPORINE",
"proprietary_name": "Cyclosporine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA065040",
"marketing_category": "ANDA",
"nonproprietary_name": "Cyclosporine",
"start_marketing_date": "20020529",
"active_numerator_strength": "25"
}Related drugs
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