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NDC 00597-0300-93 Synjardy 12.5; 1000 mg/1; mg/1 Details
Synjardy 12.5; 1000 mg/1; mg/1
Synjardy is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Empagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in people with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Empagliflozin is also used to reduce the risk of stroke, heart attack, or death in people who have type 2 diabetes along with heart and blood vessel disease. Empagliflozin is also used in adults with heart failure to reduce the risk of needing to be hospitalized and death due to heart and blood vessel disease. Empagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Empagliflozin 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: 00597-0300-93Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Empagliflozin
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: 00597-0300-93Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metformin
Product Information
| NDC | 00597-0300 |
|---|---|
| Product ID | 0597-0300_f81d39d1-538b-491d-94a7-8d0c788e5bcf |
| Associated GPIs | 27996002407550 |
| GCN Sequence Number | 076941 |
| GCN Sequence Number Description | empagliflozin/metformin HCl TAB BP 24H 12.5-1000 ORAL |
| HIC3 | C4E |
| HIC3 Description | ANTIHYPERGLYCEMIC-SGLT2 INHIBITOR-BIGUANIDE COMBS. |
| GCN | 42787 |
| HICL Sequence Number | 042183 |
| HICL Sequence Number Description | EMPAGLIFLOZIN/METFORMIN HCL |
| Brand/Generic | Brand |
| Proprietary Name | Synjardy |
| Proprietary Name Suffix | XR |
| Non-Proprietary Name | empagliflozin, metformin hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 1000 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Pharmaceutical Class | Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208658 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00597-0300-93 (00597030093)
| NDC Package Code | 0597-0300-93 |
|---|---|
| Billing NDC | 00597030093 |
| Package | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-93) |
| Marketing Start Date | 2016-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 9.76257 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | SYNJARDY XR 12.5-1,000 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |