FDA.reportPublic FDA data

Insulin Glargine

Product NDC
0955-1729
11-digit product format
009551729
Labeler code
0955
Product ID
0955-1729_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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0955-1729DDiscontinued by firm2026-08-17
excluded packagepackage0955-17290955-1729-01DDiscontinued by firm2026-08-17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1729-01ML - Milliliter0955-1729157726d1-2756-4f94-b82a-148aeae66cdf12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1729INSULIN 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0955-1729-01009551729011 VIAL, GLASS in 1 CARTON (0955-1729-01) > 10 mL in 1 VIAL, GLASS2022-05-020000-00-00NoNoCurrent