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United States · US · US:0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13
Cyclosporine
Orange BookUNIISPLATC S01XA18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103788760586 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE
- ndc11037887609112 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A205894
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": "0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13",
"productndc": "0378-8760",
"dosage_form": "EMULSION",
"orange_book": {
"appl_no": "205894",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.05%",
"product_no": "001",
"approval_date": "Feb 2, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYCLOSPORINE",
"proprietary_name": "Cyclosporine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205894",
"marketing_category": "ANDA",
"nonproprietary_name": "cyclosporine",
"start_marketing_date": "20220203",
"active_numerator_strength": ".5"
}Related drugs
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