UDENYCA
- Product NDC
- 70114-120
- 11-digit product format
- 701140120
- Labeler code
- 70114
- Product ID
- 70114-120_7a30003f-a148-4c35-bf21-b4822e970eb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim-cbqv
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Coherus Oncology, Inc.
- Application
- BLA761039
- Marketing category
- BLA
- Marketing start
- 2023-03-06
- Substance
- PEGFILGRASTIM
- Active strength
- 6 mg/.6mL
- Pharmacologic classes
- Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 3A58010674 | PEGFILGRASTIM | 208265-92-3 | PEGFILGRASTIM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70114-120-01 | 70114012001 | 1 SYRINGE in 1 CARTON (70114-120-01) / .6 mL in 1 SYRINGE | 1 syringe | 2023-03-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| UDENYCA | Coherus Oncology, Inc. | 2025-08-14 | HUMAN PRESCRIPTION DRUG LABEL | 13 |