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NDC 00310-6135-30 KOMBIGLYZE 500; 5 mg/1; mg/1 Details
KOMBIGLYZE 500; 5 mg/1; mg/1
KOMBIGLYZE is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Metformin is used alone or with other medications, including insulin, 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). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin 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). 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. Taking 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.
Related Packages: 00310-6135-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metformin
Saxagliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals when blood sugar is high. Saxagliptin 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) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). 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. Taking 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.
Related Packages: 00310-6135-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Saxagliptin
Product Information
| NDC | 00310-6135 |
|---|---|
| Product ID | 0310-6135_18325f97-e837-472a-9118-f1fb8b9b71e7 |
| Associated GPIs | 27992502607530 |
| GCN Sequence Number | 066816 |
| GCN Sequence Number Description | saxagliptin HCl/metformin HCl TBMP 24HR 5 MG-500MG ORAL |
| HIC3 | C4F |
| HIC3 Description | ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS. |
| GCN | 29118 |
| HICL Sequence Number | 037246 |
| HICL Sequence Number Description | SAXAGLIPTIN HCL/METFORMIN HCL |
| Brand/Generic | Brand |
| Proprietary Name | KOMBIGLYZE |
| Proprietary Name Suffix | XR |
| Non-Proprietary Name | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 500; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Pharmaceutical Class | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA200678 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-6135-30 (00310613530)
| NDC Package Code | 0310-6135-30 |
|---|---|
| Billing NDC | 00310613530 |
| Package | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6135-30) |
| Marketing Start Date | 2015-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 15.48 |
| Pricing Unit | EA |
| Effective Date | 2023-01-01 |
| NDC Description | KOMBIGLYZE XR 5-500 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |