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United States · US · US:76075-103_600cd22c-3a74-442e-a65d-c06d47bb892a
KYPROLIS
Orange BookUNIISPLATC L01XG02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOnyx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XG02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1176075103011 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-01) / 10 mL in 1 VIAL, SINGLE-DOSE
- ndc1176075103211 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-21) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
72X6E3J5AR
CARFILZOMIB
RxCUI 1302966
Orange Book
N202714
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "72X6E3J5AR",
"rxcui": "1302966",
"inchikey": "BLMPQMFVWMYDKT-NZTKNTHTSA-N",
"display_name": "CARFILZOMIB",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"ea66eb30-e665-4693-99a1-a9d3b4bbe2d6": {
"match": "brand_token",
"title": "KYPROLIS (CARFILZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ONYX PHARMACEUTICALS, INC.]",
"spl_version": "59",
"published_date": "2025-06-26"
}
},
"productid": "76075-103_600cd22c-3a74-442e-a65d-c06d47bb892a",
"productndc": "76075-103",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "202714",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "60MG/VIAL",
"product_no": "001",
"approval_date": "Jul 20, 2012"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG/VIAL",
"product_no": "002",
"approval_date": "Jun 3, 2016"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/VIAL",
"product_no": "003",
"approval_date": "Jun 7, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARFILZOMIB",
"proprietary_name": "KYPROLIS",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA202714",
"marketing_category": "NDA",
"nonproprietary_name": "carfilzomib",
"start_marketing_date": "20180523",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code L01XG02.
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