NDC 0069-0291

Nivestym

Filgrastim-aafi

Nivestym is a 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: 0069-0291_3a976868-6b9c-44b2-987a-3ec9cda3e7a1
• NDC: 0069-0291
• Product Type: Human Prescription Drug
• Proprietary Name: Nivestym
• Generic Name: Filgrastim-aafi
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-09-24
• Marketing Category: BLA / BLA
• Application Number: BLA761080
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: FILGRASTIM
• Active Ingredient Strength: 300 ug/.5mL
• 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 0069-0291-01

1 SYRINGE in 1 CARTON (0069-0291-01) > .5 mL in 1 SYRINGE

• Marketing Start Date: 2018-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0291-10 [00069029110]

Nivestym INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-24

NDC 0069-0291-01 [00069029101]

Nivestym INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA761080
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-09-24

Drug Details

Active Ingredients

Ingredient	Strength
FILGRASTIM	300 ug/.5mL

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