COSELA

Product NDC: 73462-101
11-digit product format: 734620101
Labeler code: 73462
Product ID: 73462-101_fd1c99c8-df20-4278-b963-603bb0c10715
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: trilaciclib
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: G1 Therapeutics, Inc.
Application: NDA214200
Marketing category: NDA
Marketing start: 2021-02-12
Marketing end: 2028-12-31
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
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
TRILACICLIB DIHYDROCHLORIDE	300 mg/20mL

Field, Values table
Field	Values
Unii	4BX07W725T
Rxcui	2479705, 2479710

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
1f0016b0-69d5-471a-8a52-92e0e819a1f3	Product name	1	20210303
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73462-101-01	COSELA	20 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	20		5
73462-101-01	COSELA	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73462-101-01	EA - Each	73462-101	909865b2-0e46-467c-ba67-db64d324813e	1	2021-03-02

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73462-101	COSELA (TRILACICLIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [G1 THERAPEUTICS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250228_4b06922c-498d-4871-a037-84a44e6a6b6c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BX07W725T	TRILACICLIB DIHYDROCHLORIDE	1977495-97-8	TRILACICLIB DIHYDROCHLORIDE
U6072DO9XG	TRILACICLIB	1374743-00-6	trilaciclib

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2479710	Cosela 300 MG Injection	PSN	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479705	trilaciclib 300 MG Injection	PSN	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479710	trilaciclib 300 MG Injection [Cosela]	SBD	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479705	trilaciclib 300 MG Injection	SCD	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479710	Cosela 300 MG (as trilaciclib dihydrochloride 349 MG) Injection	SY	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479710	Cosela 300 MG Injection	SY	4b06922c-498d-4871-a037-84a44e6a6b6c	5
2479705	trilaciclib 300 MG (as trilaciclib dihydrochloride 349 MG) Injection	SY	4b06922c-498d-4871-a037-84a44e6a6b6c	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73462-101-01	73462010101	1 VIAL, GLASS in 1 CARTON (73462-101-01) / 20 mL in 1 VIAL, GLASS	2021-02-12	2028-12-31	No	No	Current