UDENYCA
- Product NDC
- 69448-025
- 11-digit product format
- 694480025
- Labeler code
- 69448
- Product ID
- 69448-025_b9326155-8307-4ac1-9c13-6598e6c7a361
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pegfilgrastim-cbqv
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Accord BioPharma, Inc.
- Application
- BLA761039
- Marketing category
- BLA
- Marketing start
- 2025-12-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UDENYCA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PEGFILGRASTIM | 6 mg/.6mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3A58010674 |
| Rxcui | 2102703, 2102705, 2632544, 2632547, 2673598, 2673602 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| 7979a9c8-e75a-40a9-87cc-a5f08355aaef | Product name | 1 | 20230626 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| c3bb58c9-5c71-4b39-a70d-70acbffd3efe | Product name | 1 | 20230127 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 4217ae0d-ff4c-46f5-9e69-8cb4b72b3e37 | Product name | 1 | 20150402 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69448-025-63 | UDENYCA | 0.6 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.6 | 4 | |
| 69448-025-63 | UDENYCA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 4 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2632544 | pegfilgrastim-cbqv 6 MG in 0.6 ML Auto-Injector | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673598 | pegfilgrastim-cbqv 6 MG in 0.6 ML On-body Injection | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102703 | pegfilgrastim-cbqv 6 MG in 0.6 ML Prefilled Syringe | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632547 | UDENYCA 6 MG in 0.6 ML Auto-Injector | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673602 | UDENYCA 6 MG in 0.6 ML Onbody Injection | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102705 | UDENYCA 6 MG in 0.6 ML Prefilled Syringe | PSN | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632547 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector [Udenyca] | SBD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673602 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Injection [Udenyca] | SBD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102705 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe [Udenyca] | SBD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632544 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Auto-Injector | SCD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673598 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Injection | SCD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102703 | 0.6 ML pegfilgrastim-cbqv 10 MG/ML Prefilled Syringe | SCD | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632547 | 0.6 ML Udenyca 10 MG/ML Auto-Injector | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673602 | 0.6 ML Udenyca 10 MG/ML Injection | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102705 | 0.6 ML Udenyca 10 MG/ML Prefilled Syringe | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632544 | pegfilgrastim-cbqv 6 MG per 0.6 ML Auto-Injector | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673598 | pegfilgrastim-cbqv 6 MG per 0.6 ML On-body Injection | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2632547 | Udenyca 6 MG per 0.6 ML Auto-Injector | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2673602 | Udenyca 6 MG per 0.6 ML Onbody Injection | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
| 2102705 | Udenyca 6 MG per 0.6 ML Prefilled Syringe | SY | 77a8576f-b91e-42ce-b613-2fa3c3d4a571 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69448-025-63 | 69448002563 | 1 SYRINGE in 1 CARTON (69448-025-63) / .6 mL in 1 SYRINGE | 1 syringe | 2025-12-15 | No | No | Current |