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United States · US · US:63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3
Romidepsin
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323926881 KIT in 1 CARTON (63323-926-88) * 2 mL in 1 VIAL, SINGLE-DOSE (63323-925-17) * 2.2 mL in 1 VIAL, SINGLE-DOSE (63323-922-03)
Annotations
Orange Book
A206254
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"73a2028d-6735-4cd4-b63d-d072df9927a1": {
"match": "brand_token",
"title": "ROMIDEPSIN KIT [FRESENIUS KABI USA, LLC]",
"spl_version": "9",
"published_date": "2026-05-28"
}
},
"productid": "63323-926_44fb8ff4-ec3d-4dcf-8e8c-207545d938a3",
"productndc": "63323-926",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "206254",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "10MG/VIAL",
"product_no": "001",
"approval_date": "Oct 12, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Romidepsin",
"active_ingred_unit": null,
"application_number": "ANDA206254",
"marketing_category": "ANDA",
"nonproprietary_name": "Romidepsin",
"start_marketing_date": "20211012",
"active_numerator_strength": null
}Access this data programmatically
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