NDC 0024-5761 Soliqua 100/33

Insulin Glargine And Lixisenatide

NDC Product Code 0024-5761

NDC CODE: 0024-5761

Proprietary Name: Soliqua 100/33 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Insulin Glargine And Lixisenatide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Lixisenatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Lixisenatide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high sugar levels (such as after a meal) and decreasing the amount of sugar your liver makes. Lixisenatide is not a substitute for insulin if you require insulin treatment.

NDC Code Structure

NDC 0024-5761-01

Package Description: 1 SYRINGE in 1 CARTON > 3 mL in 1 SYRINGE

NDC 0024-5761-05

Package Description: 5 SYRINGE in 1 CARTON > 3 mL in 1 SYRINGE (0024-5761-02)

NDC Product Information

Soliqua 100/33 with NDC 0024-5761 is a a human prescription drug product labeled by Sanofi-aventis U.s. Llc. The generic name of Soliqua 100/33 is insulin glargine and lixisenatide. The product's dosage form is injection, solution and is administered via subcutaneous form.

Labeler Name: Sanofi-aventis U.s. Llc

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Soliqua 100/33 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • INSULIN GLARGINE 100 U/mL
  • LIXISENATIDE 33 ug/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ZINC CHLORIDE (UNII: 86Q357L16B)
  • METACRESOL (UNII: GGO4Y809LO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • METHIONINE (UNII: AE28F7PNPL)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Insulin - [Chemical/Ingredient]
  • Insulin Analog - [EPC] (Established Pharmacologic Class)
  • GLP-1 Receptor Agonist - [EPC] (Established Pharmacologic Class)
  • Glucagon-Like Peptide 1 - [CS]
  • Glucagon-like Peptide-1 (GLP-1) Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sanofi-aventis U.s. Llc
Labeler Code: 0024
FDA Application Number: BLA208673 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-21-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.