FDA.reportPublic FDA data

Insulin Glargine

Product NDC
83257-014
Requested package NDC
83257-014-11
11-digit product format
832570014
Labeler code
83257
Product ID
83257-014_1788fd3f-09d7-eb86-5e9e-db823fa41a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin Glargine-yfgn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Biocon Biologics Inc.
Application
BLA761201
Marketing category
BLA
Marketing start
2023-07-28
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Insulin Glargine
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
2563971Internal RxNorm lookup
2563976Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ac85ebb-5594-59c8-77fd-df254329d151Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
a9e2da77-dd6b-4b0e-9065-a13f87955fe1Product name120220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cbProduct name120220207
1c45812e-8815-4d17-83e9-a18ac8df9badProduct name120210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3bProduct name220200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8Product name220200323
e43198b7-315b-480b-8517-8809d5ca232aProduct name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83257-014-11Insulin Glargine1 in 1 CARTONINJECTION, SOLUTION18
83257-014-11Insulin Glargine10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-014INSULIN GLARGINE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.]8Current NDC, 2 package rows20250516_3ac85ebb-5594-59c8-77fd-df254329d151.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin GlargineINSULIN GLARGINE-YFGNBiocon Biologics Inc.3ac85ebb-5594-59c8-77fd-df254329d1512026-01-23Warnings, Adverse reactionsExact identifier
application number: BLA761201
ndc (package): 83257-014-11
ndc (product): 83257-014
ndc11 (package): 83257001411
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.72cfe377-52f6-0348-fc71-5d4ac1992ffb2025-07-24Warnings, Adverse reactionsExact identifier
application number: BLA761201
INSULIN GLARGINEINSULIN GLARGINE-YFGNCivica, Inc.216f2167-c201-76fe-81ed-0d51fe53832f2025-07-03Warnings, Adverse reactionsExact identifier
application number: BLA761201
SEMGLEEINSULIN GLARGINE-YFGNBiocon Biologics Inc.8cf5544f-87d6-468b-f6ae-898b1fdb5d802025-03-03Warnings, Adverse reactionsExact identifier
application number: BLA761201

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761201Semgleeinsulin glargine-yfgn351(k) InterchangeableRx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2563976insulin glargine-yfgn 100 UNT/ML Injectable SolutionPSN3ac85ebb-5594-59c8-77fd-df254329d1518
2563971insulin glargine-yfgn 300 UNT in 3 ML Pen InjectorPSN3ac85ebb-5594-59c8-77fd-df254329d1518
25639713 ML insulin glargine-yfgn 100 UNT/ML Pen InjectorSCD3ac85ebb-5594-59c8-77fd-df254329d1518
2563976insulin glargine-yfgn 100 UNT/ML Injectable SolutionSCD3ac85ebb-5594-59c8-77fd-df254329d1518
2563971insulin glargine-yfgn 100 UNT/ML per 3 ML Pen InjectorSY3ac85ebb-5594-59c8-77fd-df254329d1518
2563971insulin glargine-yfgn 300 UNT per 3 ML Pen InjectorSY3ac85ebb-5594-59c8-77fd-df254329d1518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83257-014-11832570014111 VIAL, MULTI-DOSE in 1 CARTON (83257-014-11) / 10 mL in 1 VIAL, MULTI-DOSE2023-07-28NoNoCurrent