Home NDC 87682-090 LANGLARA
Product NDC 87682-090
11-digit product format 876820090
Labeler code 87682
Product ID 87682-090_55fe4d38-f4dd-bde7-e063-6394a90a44ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name insulin glargine-aldy
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Lanexa Biologics, LLC
Application BLA761412
Marketing category BLA
Marketing start 2026-07-01
Substance INSULIN GLARGINE
Active strength 100 [iU]/mL
Pharmacologic classes Insulin Analog [EPC]; Insulin [CS]
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base LANGLARA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INSULIN GLARGINE 100 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2ZM8CX04RZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2746568 Internal RxNorm lookup 2746571 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 761412 Langlara insulin glargine-aldy 351(k) Interchangeable Rx 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 87682-090-05 87682009005 5 SYRINGE in 1 CARTON (87682-090-05) / 3 mL in 1 SYRINGE (87682-090-01) 5 syringe 2026-07-01 0 Current