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 Identifiers#

Field, Values table
FieldValues
Unii2ZM8CX04RZ, 74O62BB01U
Rxcui1858995, 1859000

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

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