FDA.reportPublic FDA data

Insulin Glargine Solostar

Product NDC
0955-1728
Requested package NDC
0955-1728-05
11-digit product format
009551728
Labeler code
0955
Product ID
0955-1728_e2de84cb-b6eb-44b6-85ee-cc57bb3080dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Winthrop U.S.
Application
BLA021081
Marketing category
BLA
Marketing start
2022-05-02
Marketing end
0000-00-00
Substance
INSULIN GLARGINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage0955-17280955-1728-05DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1728-01ML - Milliliter0955-1728e6297f3f-928a-43e2-be36-00d660e0449912022-11-07
0955-1728-05ML - Milliliter0955-17284f534cf1-6805-41ef-a875-8ab8a752cec412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1728INSULIN GLARGINE INJECTION, SOLUTION INSULIN GLARGINE SOLOSTAR (INSULIN GLARGINE) INJECTION, SOLUTION [WINTHROP U.S.]9Legacy NDC20240104_406883ea-7f97-4eff-8d43-0bab004654f1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lantus SolostarINSULIN GLARGINEsanofi-aventis U.S. LLCd5e07a0c-7e14-4756-9152-9fea485d654a2025-06-02Warnings, Adverse reactionsExact identifier
application number: BLA021081
Insulin Glargine SolostarINSULIN GLARGINEA-S Medication Solutions9835904f-64f5-42b3-9ac9-89e4aaa5182a2023-11-01Warnings, Adverse reactionsExact identifier
application number: BLA021081
LANTUS SOLOSTARINSULIN GLARGINEA-S Medication Solutions3a97c40f-0c83-42d7-a8ee-484b208db4e32023-07-22Warnings, Adverse reactionsExact identifier
application number: BLA021081
Lantus SolostarINSULIN GLARGINEA-S Medication Solutions632d9f68-f184-43d5-b184-a3af23f12ad92023-06-06Warnings, Adverse reactionsExact identifier
application number: BLA021081
LantusINSULIN GLARGINEA-S Medication Solutionsae27bb66-5dbe-4f01-a89e-f4fa7cb09c992023-02-04Warnings, Adverse reactionsExact identifier
application number: BLA021081

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021081Lantusinsulin glargine351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847230insulin glargine 100 UNT/ML in 3 ML Pen InjectorPSN9835904f-64f5-42b3-9ac9-89e4aaa5182a3
8472303 ML insulin glargine 100 UNT/ML Pen InjectorSCD9835904f-64f5-42b3-9ac9-89e4aaa5182a3
8472303 ML insulin analog, glargine 100 UNT/ML Pen InjectorSY9835904f-64f5-42b3-9ac9-89e4aaa5182a3
847230insulin analog, glargine 300 UNT Pen InjectorSY9835904f-64f5-42b3-9ac9-89e4aaa5182a3
847230insulin glargine 300 UNT per 3 ML Pen InjectorSY9835904f-64f5-42b3-9ac9-89e4aaa5182a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0955-1728-05009551728055 SYRINGE in 1 CARTON (0955-1728-05) > 3 mL in 1 SYRINGE (0955-1728-01) 5 syringe2022-05-020000-00-00NoNoCurrent