FDA.reportPublic FDA data

Soliqua 100/33

Product NDC
0024-5761
11-digit product format
000245761
Labeler code
0024
Product ID
0024-5761_dd3cca75-32f2-4e6d-8121-20f47e101495
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin glargine and lixisenatide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Sanofi-Aventis U.S. LLC
Application
BLA208673
Marketing category
BLA
Marketing start
2016-11-21
Substance
INSULIN GLARGINE; LIXISENATIDE
Active strength
100; 33 U/mL; ug/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Soliqua 100/33
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN GLARGINE100 U/mL
LIXISENATIDE33 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ZM8CX04RZInternal UNII lookup
74O62BB01UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1858995Internal RxNorm lookup
1859000Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bba538b-cf7c-4310-ae8f-cb711ed21bccAvailable 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
43402278-76e5-48d0-afb6-f3393f8b85b7Product name220200325
256d5b66-c6d0-4302-bcdf-00cf53e72c3bProduct name220200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8Product name220200323
e43198b7-315b-480b-8517-8809d5ca232aProduct name220200323
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0024-5761-01Soliqua 100/333 mL in 1 SYRINGEINJECTION, SOLUTION325
0024-5761-01Soliqua 100/331 in 1 CARTONINJECTION, SOLUTION125
0024-5761-02Soliqua 100/333 mL in 1 SYRINGEINJECTION, SOLUTION325
0024-5761-05Soliqua 100/335 in 1 CARTONINJECTION, SOLUTION525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0024-5761-05ML - Milliliter0024-5761e7530ee5-02ef-49cc-b454-5fb99d9b030d12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0024-5761SOLIQUA 100/33 (INSULIN GLARGINE AND LIXISENATIDE) INJECTION, SOLUTION [SANOFI-AVENTIS U.S. LLC]19Current NDC, Legacy NDC, 4 package rows20241114_4bba538b-cf7c-4310-ae8f-cb711ed21bcc.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
Soliqua 100/33INSULIN GLARGINE AND LIXISENATIDESanofi-Aventis U.S. LLC4bba538b-cf7c-4310-ae8f-cb711ed21bcc2026-03-18Warnings, Adverse reactionsExact identifier
application number: BLA208673
ndc (product): 0024-5761

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
208673Soliqua 100/33insulin glargine and lixisenatide351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1858995insulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML in 3 ML Pen InjectorPSN4bba538b-cf7c-4310-ae8f-cb711ed21bcc25
1859000Soliqua 100/33 in 3 ML Pen InjectorPSN4bba538b-cf7c-4310-ae8f-cb711ed21bcc25
18590003 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen Injector [Soliqua]SBD4bba538b-cf7c-4310-ae8f-cb711ed21bcc25
18589953 ML insulin glargine 100 UNT/ML / lixisenatide 0.033 MG/ML Pen InjectorSCD4bba538b-cf7c-4310-ae8f-cb711ed21bcc25
1858995insulin glargine 100 UNT/ML / lixisenatide 33 MCG/ML per 3 ML Pen InjectorSY4bba538b-cf7c-4310-ae8f-cb711ed21bcc25
1859000Soliqua 100/33 per 3 ML Pen InjectorSY4bba538b-cf7c-4310-ae8f-cb711ed21bcc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0024-5761-01000245761011 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE1 syringe2016-11-210000-00-00NoNoCurrent
0024-5761-02000245761023 mL in 1 SYRINGE3 mlHistorical
0024-5761-05000245761055 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) 5 syringe2016-11-210000-00-00NoNoCurrent