NDC 0069-0294

Nivestym

Filgrastim-aafi

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

• Product ID: 0069-0294_3a976868-6b9c-44b2-987a-3ec9cda3e7a1
• NDC: 0069-0294
• Product Type: Human Prescription Drug
• Proprietary Name: Nivestym
• Generic Name: Filgrastim-aafi
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2019-03-11
• Marketing Category: BLA / BLA
• Application Number: BLA761080
• Labeler Name: Pfizer Laboratories Div Pfizer 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 0069-0294-10

10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) > 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)

• Marketing Start Date: 2019-03-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0294-10 [00069029410]

Nivestym INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-11

NDC 0069-0294-01 [00069029401]

Nivestym INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-11

Drug Details

Active Ingredients

Ingredient	Strength
FILGRASTIM	480 ug/1.6mL

OpenFDA Data

• SPL SET ID: d23ab39c-b6ec-41cf-a529-9dd2852c9d9a
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • PVI5M0M1GW
• RxNorm Concept Unique ID - RxCUI:
  • 2057205
  • 2057212
  • 2057200
  • 2057215
  • 2057216
  • 2057218
  • 2057219
  • 2057209

Pharmacological Class

• Granulocyte Colony-Stimulating Factor [CS]
• Granulocyte-Macrophage Colony-Stimulating Factor [CS]
• Increased Myeloid Cell Production [PE]
• Leukocyte Growth Factor [EPC]
• 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 "Nivestym" or generic name "Filgrastim-aafi"

NDC	Brand Name	Generic Name
0069-0291	Nivestym	filgrastim-aafi
0069-0292	Nivestym	filgrastim-aafi
0069-0293	Nivestym	filgrastim-aafi
0069-0294	Nivestym	filgrastim-aafi