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NDC 00006-0080-82 JANUMET 1000; 50 mg/1; mg/1 Details
JANUMET 1000; 50 mg/1; mg/1
JANUMET is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE.
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: 00006-0080-82Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metformin
Sitagliptin 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). Sitagliptin 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. Sitagliptin 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: 00006-0080-82Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sitagliptin
Product Information
| NDC | 00006-0080 |
|---|---|
| Product ID | 0006-0080_40b87f24-8005-4ee7-b162-94690443fdb0 |
| Associated GPIs | 27992502707530 |
| GCN Sequence Number | 068539 |
| GCN Sequence Number Description | sitagliptin phos/metformin HCl TBMP 24HR 50-1000 MG ORAL |
| HIC3 | C4F |
| HIC3 Description | ANTIHYPERGLYCEMIC,DPP-4 INHIBITOR-BIGUANIDE COMBS. |
| GCN | 31340 |
| HICL Sequence Number | 034665 |
| HICL Sequence Number Description | SITAGLIPTIN PHOSPHATE/METFORMIN HCL |
| Brand/Generic | Brand |
| Proprietary Name | JANUMET |
| Proprietary Name Suffix | XR |
| Non-Proprietary Name | sitagliptin and metformin hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 1000; 50 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
| Labeler Name | Merck Sharp & Dohme LLC |
| 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 | NDA202270 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00006-0080-82 (00006008082)
| NDC Package Code | 0006-0080-82 |
|---|---|
| Billing NDC | 00006008082 |
| Package | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0080-82) |
| Marketing Start Date | 2012-02-02 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 9.16059 |
| Pricing Unit | EA |
| Effective Date | 2024-01-06 |
| NDC Description | JANUMET XR 50-1,000 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |