NYVEPRIA: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 6 mg/0.6 mL Syringe Label

Nyvepria™
(pegfilgrastim-apgf) Injection

Rx only

6 mg/0.6 mL

For Subcutaneous Use Only
Single-Dose Prefilled Syringe
with Needle Guard

NDC 0069-0324-01
Mfd by Hospira, Inc., a Pfizer
Company Lake Forest, IL 60045 USAUS License No. 1974

PAA147907

PRINCIPAL DISPLAY PANEL — 6 mg/0.6 mL Syringe Carton — PAA185776

Nyvepria™
(pegfilgrastim-apgf) Injection

6 mg/0.6 mL

For Subcutaneous Use Only
Sterile Solution — No Preservative

1 x 6 mg/0.6 mL
Single-Dose Prefilled Syringe
with Needle Guard

Pegylated Recombinant Methionyl Human
Granulocyte Colony-Stimulating Factor(PEG-r-metHuG-CSF) derived from E coli

NDC 0069-0324-01

Rx Only

PRINCIPAL DISPLAY PANEL — 6 mg/0.6 mL Syringe Carton — PAA185777

Nyvepria™
(pegfilgrastim-apgf) Injection

6 mg/0.6 mL

For Subcutaneous Use Only
Sterile Solution — No Preservative

1 x 6 mg/0.6 mL Single-Dose
Prefilled Syringe with Needle Guard

Pegylated Recombinant Methionyl Human
Granulocyte Colony-Stimulating Factor(PEG-r-metHuG-CSF) derived from E coli

NDC 0069-0324-01

Rx Only

NYVEPRIA pegfilgrastim-apgf injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0324 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEGFILGRASTIM (PEGFILGRASTIM) PEGFILGRASTIM 6 mg in 0.6 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID POLYSORBATE 20 SODIUM ACETATE SORBITOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0069-0324-01 1 CARTON in 1 CARTON contains a CARTON 1 1 SYRINGE in 1 CARTON This package is contained within the CARTON (0069-0324-01) and contains a SYRINGE 1 0.6 mL in 1 SYRINGE This package is contained within a CARTON and a CARTON (0069-0324-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761111 12/15/2020

Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)

Establishment
Name	Address	ID/FEI	Operations
Hospira Zagreb d.o.o.		500625201	ANALYSIS (0069-0324), MANUFACTURE (0069-0324), API MANUFACTURE (0069-0324), PACK (0069-0324), LABEL (0069-0324)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Inc		004954111	ANALYSIS (0069-0324)

Revised: 03/2023 Pfizer Laboratories Div Pfizer Inc