Prescription drug · BLA
Udenyca (pegfilgrastim-cbqv) NDC 70114-120
Pegfilgrastim 6 mg/.6mL · Injection, Solution · Subcutaneous · Coherus Oncology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70114-120-01 | 70114012001 | 1 SYRINGE in 1 CARTON (70114-120-01) / .6 mL in 1 SYRINGEMarketed from Mar 6, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Udenyca
- Generic name (nonproprietary)
- pegfilgrastim-cbqv
- Active ingredients
- Pegfilgrastim — 6 mg/.6mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Coherus Oncology, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761039
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 70114-120_7a30003f-a148-4c35-bf21-b4822e970eb5SPL ID 7a30003f-a148-4c35-bf21-b4822e970eb5SPL set ID a8c290ee-b699-4395-a596-1453d4a4b4ebRxCUI 2102703, 2102705, 2632544, 2632547, 2673598, 2673602UNII 3A58010674
- Pharmacologic class
- Leukocyte Growth Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J2506 — Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Billing unit: 0.5 mg. Units on the claim = dose given ÷ 0.5 mg.
Pegfilgrastim biosimilars have their own HCPCS codes.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470114012001followed by a unit qualifier and the quantityPackage 70114-0120-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
UDENYCA is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA is indicated to decrease the incide…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761039
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Udenycapegfilgrastim-cbqv | Pegfilgrastim 6 mg/.6mL | Injection, SolutionSubcutaneous | Accord BioPharma, Inc. | 69448-027 |
| Udenycapegfilgrastim-cbqv | Pegfilgrastim 6 mg/.6mL | Injection, SolutionSubcutaneous | Accord BioPharma, Inc. | 69448-025 |
| Udenycapegfilgrastim-cbqv | Pegfilgrastim 6 mg/.6mL | Injection, SolutionSubcutaneous | Accord BioPharma, Inc. | 69448-026 |
| Udenycapegfilgrastim-cbqv | Pegfilgrastim 6 mg/.6mL | Injection, SolutionSubcutaneous | Coherus Oncology, Inc. | 70114-101 |
| Udenycapegfilgrastim-cbqv | Pegfilgrastim 6 mg/.6mL | Injection, SolutionSubcutaneous | Coherus Oncology, Inc. | 70114-130 |