NDC 67457-833

Fulphila

Pegfilgrastim

Fulphila is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Pegfilgrastim.

• Product ID: 67457-833_2b0c5846-65cb-4e6c-ab4c-407c11116519
• NDC: 67457-833
• Product Type: Human Prescription Drug
• Proprietary Name: Fulphila
• Generic Name: Pegfilgrastim
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-07-09
• Marketing Category: BLA / BLA
• Application Number: BLA761075
• Labeler Name: Mylan Institutional LLC
• 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: 2020-12-31

Packaging

NDC 67457-833-06

1 SYRINGE in 1 CARTON (67457-833-06) > .6 mL in 1 SYRINGE

• Marketing Start Date: 2018-07-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-833-06 [67457083306]

Fulphila INJECTION

• Marketing Category: BLA
• Application Number: BLA761075
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-07-09

Drug Details

Pharmacological Class

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

NDC Crossover Matching brand name "Fulphila" or generic name "Pegfilgrastim"

NDC	Brand Name	Generic Name
67457-833	Fulphila	pegfilgrastim
70121-1627	FYLNETRA	pegfilgrastim
55513-190	Neulasta	pegfilgrastim
55513-192	Neulasta	pegfilgrastim