FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANGLARAINSULIN GLARGINE-ALDYLanexa Biologics, LLC5328761e-59d3-ca7a-e063-6394a90ae8102026-06-07Warnings, Adverse reactionsExact identifier
application number: BLA761412
ndc (product): 87682-090

Additional Listing Data#

Finished product
Yes
Brand name base
LANGLARA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ZM8CX04RZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2746568Internal RxNorm lookup
2746571Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5328761e-59d3-ca7a-e063-6394a90ae810Available on FDA.report

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761412Langlarainsulin glargine-aldy351(k) InterchangeableRx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
87682-090-05876820090055 SYRINGE in 1 CARTON (87682-090-05) / 3 mL in 1 SYRINGE (87682-090-01)5 syringe2026-07-010Current