Home NDC 73594-0101 COSELA
Product NDC 73594-0101
11-digit product format 735940101
Labeler code 73594
Product ID 73594-0101_8b1ee2ee-7097-4ded-9755-ffac490337c1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trilaciclib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Pharmacosmos Therapeutics Inc.
Application NDA214200
Marketing category NDA
Marketing start 2025-08-25
Substance TRILACICLIB DIHYDROCHLORIDE
Active strength 300 mg/20mL
Pharmacologic classes Cyclin-dependent Kinase 4 Inhibitors [MoA], Cyclin-dependent Kinase 6 Inhibitors [MoA], Kinase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214200-001 COSELA TRILACICLIB DIHYDROCHLORIDE EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12
Orange Book patents# Current patent rows page 1 of 1 · 17 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214200-001 10189849 2031-10-25 Drug substance 2021-03-10 N214200-001 10189850 2031-10-25 Drug product 2021-03-10 N214200-001 10927120 2031-10-25 Drug product 2021-03-10 N214200-001 11040042 2031-10-25 Drug product 2021-07-21 N214200-001 8598197 2031-10-25 Drug substance, Drug product 2021-03-10 N214200-001 9957276 2031-10-25 Drug substance 2021-03-10 N214200-001 10085992 2034-03-14 U-3081 2021-03-10 N214200-001 10966984 2034-03-14 U-3079 2021-05-06 N214200-001 10966984 2034-03-14 U-3080 2021-05-06 N214200-001 11717523 2034-03-14 U-3678 2023-08-30 N214200-001 11717523 2034-03-14 U-3679 2023-08-30 N214200-001 9487530 2034-03-14 U-3079 2021-03-10 N214200-001 9487530 2034-03-14 U-3080 2021-03-10 N214200-001 8598186 2034-12-30 Drug substance, Drug product 2021-03-10 N214200-001 12527798 2037-12-05 U-3504 2026-01-21 N214200-001 11529352 2039-07-23 U-3504 2023-01-12 N214200-001 12168666 2040-11-13 Drug substance, Drug product 2025-01-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214200-001 NCE 2026-02-12
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214200-001 COSELA EQ 300MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-12 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 13 · 493 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N214200-001 10189849 2031-10-25 Drug substance 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 10189850 2031-10-25 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 10927120 2031-10-25 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 11040042 2031-10-25 Drug product 2021-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 8598197 2031-10-25 Drug substance, Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 9957276 2031-10-25 Drug substance 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 10085992 2034-03-14 U-3081 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 10966984 2034-03-14 U-3079 2021-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 10966984 2034-03-14 U-3080 2021-05-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 11717523 2034-03-14 U-3678 2023-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 11717523 2034-03-14 U-3679 2023-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 9487530 2034-03-14 U-3079 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 9487530 2034-03-14 U-3080 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 8598186 2034-12-30 Drug substance, Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 12527798 2037-12-05 U-3504 2026-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 11529352 2039-07-23 U-3504 2023-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214200-001 12168666 2040-11-13 Drug substance, Drug product 2025-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214200-001 10189849 2031-10-25 Drug substance 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 10189850 2031-10-25 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 10927120 2031-10-25 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 11040042 2031-10-25 Drug product 2021-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 8598197 2031-10-25 Drug substance, Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 9957276 2031-10-25 Drug substance 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 10085992 2034-03-14 U-3081 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 10966984 2034-03-14 U-3079 2021-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 10966984 2034-03-14 U-3080 2021-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 11717523 2034-03-14 U-3678 2023-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 11717523 2034-03-14 U-3679 2023-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 9487530 2034-03-14 U-3079 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 9487530 2034-03-14 U-3080 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 8598186 2034-12-30 Drug substance, Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 12527798 2037-12-05 U-3504 2026-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 11529352 2039-07-23 U-3504 2023-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214200-001 12168666 2040-11-13 Drug substance, Drug product 2025-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 10189849 2031-10-25 Drug substance 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 10189850 2031-10-25 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 10927120 2031-10-25 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 11040042 2031-10-25 Drug product 2021-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 8598197 2031-10-25 Drug substance, Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214200-001 9957276 2031-10-25 Drug substance 2021-03-10 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base COSELA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRILACICLIB DIHYDROCHLORIDE 300 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4BX07W725T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2479705 Internal RxNorm lookup 2479710 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73594-0101-1 COSELA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3 73594-0101-1 COSELA 20 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 20 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73594-0101-1 73594010101 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS 2025-08-25 No No Current