udenyca

Generic: pegfilgrastim-cbqv

Labeler: coherus oncology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name udenyca
Generic Name pegfilgrastim-cbqv
Labeler coherus oncology, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

pegfilgrastim 6 mg/.6mL

Manufacturer
Coherus Oncology, Inc.

Identifiers & Regulatory

Product NDC 70114-120
Product ID 70114-120_7a30003f-a148-4c35-bf21-b4822e970eb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761039
Listing Expiration 2026-12-31
Marketing Start 2023-03-06

Pharmacologic Class

Established (EPC)
leukocyte growth factor [epc]
Chemical Structure
granulocyte colony-stimulating factor [cs]
Physiologic Effect
increased myeloid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70114120
Hyphenated Format 70114-120

Supplemental Identifiers

RxCUI
2102703 2102705 2632544 2632547 2673598 2673602
UNII
3A58010674
NUI
M0024696 N0000009451 N0000175666

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name udenyca (source: ndc)
Generic Name pegfilgrastim-cbqv (source: ndc)
Application Number BLA761039 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.6mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (70114-120-01) / .6 mL in 1 SYRINGE
source: ndc

Packages (1)

70114-120-01 1 SYRINGE in 1 CARTON (70114-120-01) / .6 mL in 1 SYRINGE

Ingredients (1)

pegfilgrastim (6 mg/.6mL)

Linked Drug Pages (1)

UDENYCA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7a30003f-a148-4c35-bf21-b4822e970eb5", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["3A58010674"], "rxcui": ["2102703", "2102705", "2632544", "2632547", "2673598", "2673602"], "spl_set_id": ["a8c290ee-b699-4395-a596-1453d4a4b4eb"], "pharm_class_cs": ["Granulocyte Colony-Stimulating Factor [CS]"], "pharm_class_pe": ["Increased Myeloid Cell Production [PE]"], "pharm_class_epc": ["Leukocyte Growth Factor [EPC]"], "manufacturer_name": ["Coherus Oncology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (70114-120-01)  / .6 mL in 1 SYRINGE", "package_ndc": "70114-120-01", "marketing_start_date": "20230306"}], "brand_name": "UDENYCA", "product_id": "70114-120_7a30003f-a148-4c35-bf21-b4822e970eb5", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "70114-120", "generic_name": "pegfilgrastim-cbqv", "labeler_name": "Coherus Oncology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "UDENYCA", "active_ingredients": [{"name": "PEGFILGRASTIM", "strength": "6 mg/.6mL"}], "application_number": "BLA761039", "marketing_category": "BLA", "marketing_start_date": "20230306", "listing_expiration_date": "20261231"}