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NDC 65162-0059-50 Saxagliptin 2.5 mg/1 Details
Saxagliptin 2.5 mg/1
Saxagliptin is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is SAXAGLIPTIN HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 65162-0059-50Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Saxagliptin
Product Information
NDC | 65162-0059 |
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Product ID | 65162-059_1bcb5eef-e494-460d-84e9-b4a421fc650d |
Associated GPIs | |
GCN Sequence Number | 065430 |
GCN Sequence Number Description | saxagliptin HCl TABLET 2.5 MG ORAL |
HIC3 | C4J |
HIC3 Description | ANTIHYPERGLYCEMIC, DPP-4 INHIBITORS |
GCN | 27393 |
HICL Sequence Number | 036471 |
HICL Sequence Number Description | SAXAGLIPTIN HCL |
Brand/Generic | Generic |
Proprietary Name | Saxagliptin |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Saxagliptin |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 2.5 |
Active Ingredient Units | mg/1 |
Substance Name | SAXAGLIPTIN HYDROCHLORIDE |
Labeler Name | Amneal Pharmaceuticals LLC |
Pharmaceutical Class | Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA205941 |
Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0059-50 (65162005950)
NDC Package Code | 65162-059-50 |
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Billing NDC | 65162005950 |
Package | 500 TABLET, FILM COATED in 1 BOTTLE (65162-059-50) |
Marketing Start Date | 2023-08-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |