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United States · US · US:73594-0101_8b1ee2ee-7097-4ded-9755-ffac490337c1
COSELA
Orange BookUNIISPLATC V03AF12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmacosmos Therapeutics Inc.
CountryUS (United States)
ATC codeV03AF12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173594010111 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
4BX07W725T
TRILACICLIB DIHYDROCHLORIDE
RxCUI 2479691
Orange Book
N214200
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4BX07W725T",
"rxcui": "2479691",
"inchikey": "BRCYOXKEDFAUSA-UHFFFAOYSA-N",
"display_name": "TRILACICLIB DIHYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b3179c19-78f3-4bf1-b73e-7f7638522ab1": {
"match": "brand_token",
"title": "COSELA (TRILACICLIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACOSMOS THERAPEUTICS INC.]",
"spl_version": "3",
"published_date": "2025-09-10"
}
},
"productid": "73594-0101_8b1ee2ee-7097-4ded-9755-ffac490337c1",
"productndc": "73594-0101",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "214200",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 300MG BASE/VIAL",
"product_no": "001",
"approval_date": "Feb 12, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRILACICLIB DIHYDROCHLORIDE",
"proprietary_name": "COSELA",
"active_ingred_unit": "mg/20mL",
"application_number": "NDA214200",
"marketing_category": "NDA",
"nonproprietary_name": "trilaciclib",
"start_marketing_date": "20250825",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code V03AF12.
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