soliqua 100/33

Generic: insulin glargine and lixisenatide

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name soliqua 100/33
Generic Name insulin glargine and lixisenatide
Labeler sanofi-aventis u.s. llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

insulin glargine 100 U/mL, lixisenatide 33 ug/mL

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0024-5761
Product ID 0024-5761_50747fb3-464f-4b71-bd57-5bf163c43d76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA208673
Listing Expiration 2026-12-31
Marketing Start 2016-11-21

Pharmacologic Class

Established (EPC)
insulin analog [epc] glp-1 receptor agonist [epc]
Mechanism of Action
glucagon-like peptide-1 (glp-1) agonists [moa]
Chemical Structure
insulin [cs] glucagon-like peptide 1 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00245761
Hyphenated Format 0024-5761

Supplemental Identifiers

RxCUI
1858995 1859000
UNII
2ZM8CX04RZ 74O62BB01U
NUI
M0011417 N0000175453 N0000178480 M0160181 N0000020058

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name soliqua 100/33 (source: ndc)
Generic Name insulin glargine and lixisenatide (source: ndc)
Application Number BLA208673 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 100 U/mL
  • 33 ug/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE
  • 5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02)
source: ndc

Packages (2)

0024-5761-01 1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE 0024-5761-05 5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02)

Ingredients (2)

insulin glargine (100 U/mL) lixisenatide (33 ug/mL)

Linked Drug Pages (1)

Soliqua 100/33 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "50747fb3-464f-4b71-bd57-5bf163c43d76", "openfda": {"nui": ["M0011417", "N0000175453", "N0000178480", "M0160181", "N0000020058"], "unii": ["2ZM8CX04RZ", "74O62BB01U"], "rxcui": ["1858995", "1859000"], "spl_set_id": ["4bba538b-cf7c-4310-ae8f-cb711ed21bcc"], "pharm_class_cs": ["Insulin [CS]", "Glucagon-Like Peptide 1 [CS]"], "pharm_class_epc": ["Insulin Analog [EPC]", "GLP-1 Receptor Agonist [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0024-5761-01)  / 3 mL in 1 SYRINGE", "package_ndc": "0024-5761-01", "marketing_start_date": "20161121"}, {"sample": false, "description": "5 SYRINGE in 1 CARTON (0024-5761-05)  / 3 mL in 1 SYRINGE (0024-5761-02)", "package_ndc": "0024-5761-05", "marketing_start_date": "20161121"}], "brand_name": "Soliqua 100/33", "product_id": "0024-5761_50747fb3-464f-4b71-bd57-5bf163c43d76", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["GLP-1 Receptor Agonist [EPC]", "Glucagon-Like Peptide 1 [CS]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]", "Insulin Analog [EPC]", "Insulin [CS]"], "product_ndc": "0024-5761", "generic_name": "insulin glargine and lixisenatide", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Soliqua 100/33", "active_ingredients": [{"name": "INSULIN GLARGINE", "strength": "100 U/mL"}, {"name": "LIXISENATIDE", "strength": "33 ug/mL"}], "application_number": "BLA208673", "marketing_category": "BLA", "marketing_start_date": "20161121", "listing_expiration_date": "20261231"}