FDA.reportPublic FDA data

SEMGLEE

Product NDC
83257-012
11-digit product format
832570012
Labeler code
83257
Product ID
83257-012_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
2027-05-31
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage83257-01283257-012-32DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

Additional Listing Data#

Finished product
Yes
Brand name base
SEMGLEE

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2563971Internal RxNorm lookup
2563973Internal RxNorm lookup
2563976Internal RxNorm lookup
2563977Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8cf5544f-87d6-468b-f6ae-898b1fdb5d80Available 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
83257-012-31SEMGLEE3 mL in 1 SYRINGEINJECTION, SOLUTION314
83257-012-31SEMGLEE1 in 1 CARTONINJECTION, SOLUTION114
83257-012-32SEMGLEE3 mL in 1 SYRINGEINJECTION, SOLUTION314
83257-012-32SEMGLEE3 in 1 CARTONINJECTION, SOLUTION314
83257-012-33SEMGLEE3 mL in 1 SYRINGEINJECTION, SOLUTION314
83257-012-33SEMGLEE5 in 1 CARTONINJECTION, SOLUTION514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-012-31ML - Milliliter83257-012653afa7d-3a68-491f-bba7-58355f33557912023-12-05
83257-012-33ML - Milliliter83257-0123926f3bc-05a4-4fa4-a3cf-51896c18409312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83257-012SEMGLEE (INSULIN GLARGINE-YFGN) INJECTION, SOLUTION [BIOCON BIOLOGICS INC.]12Current NDC, 6 package rows20250516_8cf5544f-87d6-468b-f6ae-898b1fdb5d80.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
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
ndc (product): 83257-012

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761201Semgleeinsulin glargine-yfgn351(k) InterchangeableRx2026-07-01

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83257-012-31832570012311 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE1 syringe2023-07-282027-05-31NoNoHistorical
83257-012-32832570012323 mL in 1 SYRINGE3 mlHistorical
83257-012-33832570012335 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE5 syringe2023-07-282027-05-31NoNoHistorical