Home NDC 0069-0324 NYVEPRIA
Product NDC 0069-0324
11-digit product format 000690324
Labeler code 0069
Product ID 0069-0324_a89f35d2-46e6-457b-a617-3c7537e6f709
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pegfilgrastim-apgf
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA761111
Marketing category BLA
Marketing start 2020-12-15
Substance PEGFILGRASTIM
Active strength 6 mg/.6mL
Pharmacologic classes Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base NYVEPRIA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEGFILGRASTIM 6 mg/.6mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3A58010674 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2469335 Internal RxNorm lookup 2469340 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-0324-01 NYVEPRIA 1 in 1 CARTON INJECTION, SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-0324 NYVEPRIA (PEGFILGRASTIM-APGF) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8 Current NDC, Legacy NDC, 1 package rows 20230630_99d30b99-2743-446b-98f3-0430bf4ea869.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NYVEPRIA PEGFILGRASTIM-APGF Pfizer Laboratories Div Pfizer Inc 99d30b99-2743-446b-98f3-0430bf4ea869 2026-06-02 Warnings, Adverse reactions Exact identifier application number: BLA761111 ndc (product): 0069-0324
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761111 Nyvepria pegfilgrastim-apgf 351(k) Biosimilar Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0069-0324-01 00069032401 1 CARTON in 1 CARTON (0069-0324-01) / 1 SYRINGE in 1 CARTON / .6 mL in 1 SYRINGE 1 carton 2020-12-15 0000-00-00 No No Current