Home NDC 71288-909 Insulin Diluting Medium for Garzulys
Product NDC 71288-909
11-digit product format 712880909
Labeler code 71288
Product ID 71288-909_dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name water injection
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS, SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application BLA761497
Marketing category BLA
Marketing start 2026-07-24
Substance WATER
Active strength 1 mL/mL
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Insulin Diluting Medium for Garzulys
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WATER 1 mL/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 059QF0KO0R Internal UNII lookup D933668QVX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2748451 Internal RxNorm lookup 2748457 Internal RxNorm lookup 2748459 Internal RxNorm lookup 2748463 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761497 Garzulys insulin aspart-fsan 351(k) Biosimilar Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 71288-909-10 71288090910 1 VIAL, GLASS in 1 CARTON (71288-909-10) / 10 mL in 1 VIAL, GLASS 2026-07-24 0 Current