FDA.reportPublic FDA data

Apidra

Product NDC
0088-2500
11-digit product format
000882500
Labeler code
0088
Product ID
0088-2500_6be54063-6912-4810-b1c7-dfca969224d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glulisine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
sanofi-aventis U.S. LLC
Application
BLA021629
Marketing category
BLA
Marketing start
2009-02-24
Substance
INSULIN GLULISINE
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Apidra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLULISINE100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7XIY785AZDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485210Internal RxNorm lookup
803194Internal RxNorm lookup
847259Internal RxNorm lookup
847261Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7af6a7a-8046-4fb4-9979-4ec4230b23aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0088-2500-33Apidra10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1028
0088-2500-33Apidra1 in 1 CARTONINJECTION, SOLUTION128
0088-2500-34Apidra1 in 1 CARTONINJECTION, SOLUTION128
0088-2500-34Apidra10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0088-2500-33ML - Milliliter0088-2500fda17893-cda8-4488-ae57-d3a714732e3f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
insulin glulisineACTIVE INGREDIENT7XIY785AZDAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
insulin glulisineACTIVE MOIETY7XIY785AZDAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
metacresolINACTIVE INGREDIENTGGO4Y809LOAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
sodium chlorideINACTIVE INGREDIENT451W47IQ8XAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
tromethamineINACTIVE INGREDIENT023C2WHX2VAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15
waterINACTIVE INGREDIENT059QF0KO0RAPIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0088-2500APIDRA (INSULIN GLULISINE) INJECTION, SOLUTION APIDRA SOLOSTAR (INSULIN GLULISINE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]24Current NDC, Legacy NDC, 4 package rows20230728_e7af6a7a-8046-4fb4-9979-4ec4230b23aa.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ApidraINSULIN GLULISINEsanofi-aventis U.S. LLCe7af6a7a-8046-4fb4-9979-4ec4230b23aa2025-11-25Warnings, Adverse reactionsExact identifier
application number: BLA021629
ndc (product): 0088-2500

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021629Apidrainsulin glulisine351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847261Apidra 100 UNT/ML in 3 ML Pen InjectorPSNe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
803194Apidra 100 UNT/ML Injectable SolutionPSNe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
847259insulin glulisine 100 UNT/ML in 3 ML Pen InjectorPSNe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
485210insulin glulisine 100 UNT/ML Injectable SolutionPSNe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
8472613 ML insulin glulisine, human 100 UNT/ML Pen Injector [Apidra]SBDe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
803194insulin glulisine, human 100 UNT/ML Injectable Solution [Apidra]SBDe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
8472593 ML insulin glulisine, human 100 UNT/ML Pen InjectorSCDe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
485210insulin glulisine, human 100 UNT/ML Injectable SolutionSCDe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
8472613 ML Apidra 100 UNT/ML Pen InjectorSYe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
803194Apidra 100 UNT/ML Injectable SolutionSYe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
847261Apidra 100 UNT/ML per 3 ML SoloSTAR PenSYe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
485210insulin analog, glulisine 100 UNT/ML Injectable SolutionSYe7af6a7a-8046-4fb4-9979-4ec4230b23aa28
847259insulin, glulisine, human 100 UNT/ML per 3 ML Pen InjectorSYe7af6a7a-8046-4fb4-9979-4ec4230b23aa28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0088-2500-33000882500331 VIAL, GLASS in 1 CARTON (0088-2500-33) / 10 mL in 1 VIAL, GLASS2009-02-240000-00-00NoNoCurrent
0088-2500-34000882500341 VIAL, GLASS in 1 CARTON (0088-2500-34) / 10 mL in 1 VIAL, GLASS2009-02-240000-00-00NoNoCurrent