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NDC 00597-0164-39 Glyxambi 25; 5 mg/1; mg/1 Details
Glyxambi 25; 5 mg/1; mg/1
Glyxambi is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is EMPAGLIFLOZIN; LINAGLIPTIN.
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: 00597-0164-39Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Empagliflozin
Linagliptin is used along with diet and exercise and sometimes with other medications 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). Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high. Linagliptin 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). Linagliptin used in combination with insulin to treat diabetes has not been studied to date. 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: 00597-0164-39Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Linagliptin
Product Information
| NDC | 00597-0164 |
|---|---|
| Product ID | 0597-0164_c00ed17d-86f6-4d4d-a26a-0cf2e7315a85 |
| Associated GPIs | 27996502300330 |
| GCN Sequence Number | 073433 |
| GCN Sequence Number Description | empagliflozin/linagliptin TABLET 25 MG-5 MG ORAL |
| HIC3 | C4W |
| HIC3 Description | ANTIHYPERGLYCEMIC, SGLT-2 AND DPP-4 INHIBITOR COMB |
| GCN | 37833 |
| HICL Sequence Number | 041724 |
| HICL Sequence Number Description | EMPAGLIFLOZIN/LINAGLIPTIN |
| Brand/Generic | Brand |
| Proprietary Name | Glyxambi |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | empagliflozin and linagliptin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 25; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | EMPAGLIFLOZIN; LINAGLIPTIN |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Pharmaceutical Class | Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA206073 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00597-0164-39 (00597016439)
| NDC Package Code | 0597-0164-39 |
|---|---|
| Billing NDC | 00597016439 |
| Package | 30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2015-01-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 19.4695 |
| Pricing Unit | EA |
| Effective Date | 2024-01-01 |
| NDC Description | GLYXAMBI 25 MG-5 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |