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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BX07W725T |
| Rxcui | 2479705, 2479710 |
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 |
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 |