NDC 55513-546

NEUPOGEN

Filgrastim

NEUPOGEN is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Filgrastim.

• Product ID: 55513-546_37a4c6e3-f99d-4526-b43a-82bb8d861c33
• NDC: 55513-546
• Product Type: Human Prescription Drug
• Proprietary Name: NEUPOGEN
• Generic Name: Filgrastim
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 1997-04-07
• Marketing Category: BLA / BLA
• Application Number: BLA103353
• Labeler Name: Amgen Inc
• Substance Name: FILGRASTIM
• Active Ingredient Strength: 480 ug/1.6mL
• 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: 2023-12-31

Packaging

NDC 55513-546-10

10 VIAL in 1 BOX (55513-546-10) > 1.6 mL in 1 VIAL (55513-546-01)

• Marketing Start Date: 1997-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-546-10 [55513054610]

NEUPOGEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103353
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-04-07

NDC 55513-546-01 [55513054601]

NEUPOGEN INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103353
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1997-04-07

Drug Details

Active Ingredients

Ingredient	Strength
FILGRASTIM	480 ug/1.6mL

OpenFDA Data

• SPL SET ID: 97cc73cc-b5b7-458a-a933-77b00523e193
• Manufacturer:
  • Amgen Inc
• UNII:
  • PVI5M0M1GW
• RxNorm Concept Unique ID - RxCUI:
  • 727545
  • 727544
  • 1649963
  • 1649964
  • 1649946
  • 1649944
  • 727535
  • 727537

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 "NEUPOGEN" or generic name "Filgrastim"

NDC	Brand Name	Generic Name
55513-209	NEUPOGEN	Filgrastim
55513-530	NEUPOGEN	Filgrastim
55513-546	NEUPOGEN	Filgrastim
55513-924	NEUPOGEN	Filgrastim
70121-1568	RELEUKO	Filgrastim
70121-1569	RELEUKO	Filgrastim
70121-1570	RELEUKO	Filgrastim
70121-1571	RELEUKO	Filgrastim