INSULIN GLARGINE

Product NDC
72572-424
11-digit product format
725720424
Labeler code
72572
Product ID
72572-424_40be8473-6e6e-3d64-cb3d-5f8060a262f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine-yfgn
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Civica, Inc.
Application
BLA761201
Marketing category
BLA
Marketing start
2025-10-30
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

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
72572-424-01INSULIN GLARGINE1 in 1 CARTONINJECTION, SOLUTION11
72572-424-01INSULIN GLARGINE3 mL in 1 SYRINGEINJECTION, SOLUTION31
72572-424-05INSULIN GLARGINE3 mL in 1 SYRINGEINJECTION, SOLUTION31
72572-424-05INSULIN GLARGINE5 in 1 CARTONINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-424-01ML - Milliliter72572-424346f3a1f-1dbd-4a2c-9ddd-fe9cc3a1a22e12026-01-08
72572-424-05ML - Milliliter72572-424b8a32bb3-0f17-47e4-ab8f-42ce44bd8d3e12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2563971insulin glargine-yfgn 300 UNT in 3 ML Pen InjectorPSN216f2167-c201-76fe-81ed-0d51fe53832f1
25639713 ML insulin glargine-yfgn 100 UNT/ML Pen InjectorSCD216f2167-c201-76fe-81ed-0d51fe53832f1
2563971insulin glargine-yfgn 100 UNT/ML per 3 ML Pen InjectorSY216f2167-c201-76fe-81ed-0d51fe53832f1
2563971insulin glargine-yfgn 300 UNT per 3 ML Pen InjectorSY216f2167-c201-76fe-81ed-0d51fe53832f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72572-424-01725720424011 SYRINGE in 1 CARTON (72572-424-01) / 3 mL in 1 SYRINGE1 syringe2025-10-30NoNoHistorical
72572-424-05725720424055 SYRINGE in 1 CARTON (72572-424-05) / 3 mL in 1 SYRINGE5 syringe2025-10-30NoNoHistorical