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NDC 00310-6780-30 QTERN 10; 5 mg/1; mg/1 Details
QTERN 10; 5 mg/1; mg/1
QTERN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AstraZeneca Pharmaceuticals LP. The primary component is DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Dapagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). It is also used to reduce the risk of needing to be hospitalized for heart failure in adults who have type 2 diabetes along with heart and blood vessel disease or who have multiple risk factors for developing heart and blood vessel disease. Dapagliflozin 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. It is also used to reduce the risk of worsening kidney disease, the need to be hospitalized for heart failure, and the risk of death due to heart disease in adults with kidney disease. Dapagliflozin 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. Dapagliflozin 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 dapagliflozin, 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: 00310-6780-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dapagliflozin
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: 00310-6780-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Saxagliptin
Product Information
| NDC | 00310-6780 |
|---|---|
| Product ID | 0310-6780_73713238-3794-4c37-be41-34e790e2111f |
| Associated GPIs | 27996502200330 |
| GCN Sequence Number | 077192 |
| GCN Sequence Number Description | dapagliflozin/saxagliptin HCl TABLET 10 MG-5 MG ORAL |
| HIC3 | C4W |
| HIC3 Description | ANTIHYPERGLYCEMIC, SGLT-2 AND DPP-4 INHIBITOR COMB |
| GCN | 43126 |
| HICL Sequence Number | 043957 |
| HICL Sequence Number Description | DAPAGLIFLOZIN PROPANEDIOL/SAXAGLIPTIN HCL |
| Brand/Generic | Brand |
| Proprietary Name | QTERN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dapagliflozin and saxagliptin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| 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 | NDA209091 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00310-6780-30 (00310678030)
| NDC Package Code | 0310-6780-30 |
|---|---|
| Billing NDC | 00310678030 |
| Package | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6780-30) |
| Marketing Start Date | 2017-12-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 17.9872 |
| Pricing Unit | EA |
| Effective Date | 2023-01-01 |
| NDC Description | QTERN 10 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 |