FDA.reportPublic FDA data

Insulin Glargine

Product NDC
83257-015
11-digit product format
832570015
Labeler code
83257
Product ID
83257-015_fb8ba940-aef7-d17f-6539-6f3a73ae3a72
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Insulin Glargine
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui2563971, 2563976

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
83257-015-31Insulin Glargine1 in 1 CARTONINJECTION, SOLUTION18
83257-015-31Insulin Glargine3 mL in 1 SYRINGEINJECTION, SOLUTION38
83257-015-32Insulin Glargine3 mL in 1 SYRINGEINJECTION, SOLUTION38
83257-015-32Insulin Glargine5 in 1 CARTONINJECTION, SOLUTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-015-31ML - Milliliter83257-0154b3a8032-0b63-45f8-bac8-9e9e1af5a06212023-12-05
83257-015-32ML - Milliliter83257-01536723443-06b2-4320-8aff-a4a88da81db412023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-015INSULIN GLARGINE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.]8Current NDC, 4 package rows20250516_3ac85ebb-5594-59c8-77fd-df254329d151.zip

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-015-31832570015311 SYRINGE in 1 CARTON (83257-015-31) / 3 mL in 1 SYRINGE1 syringe2023-07-28NoNoHistorical
83257-015-32832570015325 SYRINGE in 1 CARTON (83257-015-32) / 3 mL in 1 SYRINGE5 syringe2023-07-28NoNoHistorical