FDA.reportPublic FDA data

SEMGLEE

Product NDC
83257-011
11-digit product format
832570011
Labeler code
83257
Product ID
83257-011_3b749417-8933-850b-1373-990e7ee8a312
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
Marketing end
2027-04-30
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEMGLEE

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ
Rxcui2563971, 2563973, 2563976, 2563977

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
83257-011-11SEMGLEE1 in 1 CARTONINJECTION, SOLUTION114
83257-011-11SEMGLEE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-011-11ML - Milliliter83257-0114cd729bc-9658-4ea6-8e2b-7685be3f4dbc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-011SEMGLEE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.]12Current NDC, 2 package rows20250516_8cf5544f-87d6-468b-f6ae-898b1fdb5d80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2563976insulin glargine-yfgn 100 UNT/ML Injectable SolutionPSN8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563971insulin glargine-yfgn 300 UNT in 3 ML Pen InjectorPSN8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563977Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable SolutionPSN8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563973Semglee (insulin glargine-yfgn) 300 UNT in 3 ML Pen InjectorPSN8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
25639733 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [Semglee]SBD8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563977insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee]SBD8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
25639713 ML insulin glargine-yfgn 100 UNT/ML Pen InjectorSCD8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563976insulin glargine-yfgn 100 UNT/ML Injectable SolutionSCD8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563971insulin glargine-yfgn 100 UNT/ML per 3 ML Pen InjectorSY8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563971insulin glargine-yfgn 300 UNT per 3 ML Pen InjectorSY8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563977Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable SolutionSY8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563973Semglee (insulin glargine-yfgn) 100 UNT/ML per 3 ML Pen InjectorSY8cf5544f-87d6-468b-f6ae-898b1fdb5d8014
2563973Semglee (insulin glargine-yfgn) 300 UNT per 3 ML Pen InjectorSY8cf5544f-87d6-468b-f6ae-898b1fdb5d8014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83257-011-11832570011111 VIAL, MULTI-DOSE in 1 CARTON (83257-011-11) / 10 mL in 1 VIAL, MULTI-DOSE2023-07-282027-04-30NoNoHistorical