NDC 70114-101

UDENYCA

Pegfilgrastim-cbqv

UDENYCA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Coherus Biosciences Inc. The primary component is Pegfilgrastim.

• Product ID: 70114-101_1a8bc7f3-f631-4ae3-a69e-a2c5357ec974
• NDC: 70114-101
• Product Type: Human Prescription Drug
• Proprietary Name: UDENYCA
• Generic Name: Pegfilgrastim-cbqv
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-11-02
• Marketing Category: BLA / BLA
• Application Number: BLA761039
• Labeler Name: Coherus BioSciences Inc
• Substance Name: PEGFILGRASTIM
• Active Ingredient Strength: 6 mg/.6mL
• Pharm Classes: Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70114-101-01

1 SYRINGE in 1 CARTON (70114-101-01) > .6 mL in 1 SYRINGE

• Marketing Start Date: 2018-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70114-101-01 [70114010101]

UDENYCA INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761039
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-02

Drug Details

Active Ingredients

Ingredient	Strength
PEGFILGRASTIM	6 mg/.6mL

OpenFDA Data

• SPL SET ID: a8c290ee-b699-4395-a596-1453d4a4b4eb
• Manufacturer:
  • Coherus BioSciences Inc
• UNII:
  • 3A58010674
• RxNorm Concept Unique ID - RxCUI:
  • 2102705
  • 2102703

Pharmacological Class

• Granulocyte Colony-Stimulating Factor [CS]
• Granulocyte-Macrophage Colony-Stimulating Factor [CS]
• Increased Myeloid Cell Production [PE]
• Leukocyte Growth Factor [EPC]