Insulin Glargine Solostar

Product NDC
0955-1728
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

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 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

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 SYRINGE5 syringe2022-05-020000-00-00NoNoCurrent