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NDC 00024-5747-02 ADLYXIN 100 ug/mL Details
ADLYXIN 100 ug/mL
ADLYXIN is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by sanofi-aventis U.S. LLC. The primary component is LIXISENATIDE.
MedlinePlus Drug Summary
Lixisenatide injection is used along with diet and exercise to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Lixisenatide injection is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Lixisenatide is not used instead of insulin to treat people with diabetes who need insulin. Lixisenatide injection is in a class of medications called incretin mimetics. It works by stimulating the pancreas to secrete insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Lixisenatide injection also slows the emptying of the stomach and causes a decrease in appetite. Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lixisenatide injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.
Related Packages: 00024-5747-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lixisenatide Injection
Product Information
NDC | 00024-5747 |
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Product ID | 0024-5747_082cf774-e9b2-fdbd-e063-6294a90a6d61 |
Associated GPIs | 2717005600D230 |
GCN Sequence Number | 071734 |
GCN Sequence Number Description | lixisenatide PEN INJCTR 20 MCG/0.2 SUBCUT |
HIC3 | C4I |
HIC3 Description | ANTIHYPERGLY,INCRETIN MIMETIC(GLP-1 RECEP.AGONIST) |
GCN | 35687 |
HICL Sequence Number | 040782 |
HICL Sequence Number Description | LIXISENATIDE |
Brand/Generic | Brand |
Proprietary Name | ADLYXIN |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Lixisenatide |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | ug/mL |
Substance Name | LIXISENATIDE |
Labeler Name | sanofi-aventis U.S. LLC |
Pharmaceutical Class | GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA208471 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00024-5747-02 (00024574702)
NDC Package Code | 0024-5747-02 |
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Billing NDC | 00024574702 |
Package | 2 SYRINGE in 1 CARTON (0024-5747-02) / 3 mL in 1 SYRINGE |
Marketing Start Date | 2016-07-27 |
NDC Exclude Flag | N |
Pricing Information | N/A |