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NDC 49502-0394-75 Insulin Glargine 100 [iU]/mL Details
Insulin Glargine 100 [iU]/mL
Insulin Glargine is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Specialty L.P.. The primary component is INSULIN GLARGINE.
MedlinePlus Drug Summary
Insulin glargine products are 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). Insulin glargine products are also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In people with type 1 diabetes, insulin glargine products must be used with another type of insulin (a short-acting insulin). In people with type 2 diabetes, insulin glargine products also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin glargine is a long-acting, synthetic version of human insulin. Insulin glargine products work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar. 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. Using 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: 49502-0394-75Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Insulin Glargine (rDNA origin) Injection
Product Information
NDC | 49502-0394 |
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Product ID | 49502-394_4ad0964c-21f9-4fd0-a8ed-c0202d1b4fce |
Associated GPIs | 2710400390D220 |
GCN Sequence Number | 082542 |
GCN Sequence Number Description | insulin glargine-yfgn INSULN PEN 100/ML (3) SUBCUT |
HIC3 | C4G |
HIC3 Description | INSULINS |
GCN | 49993 |
HICL Sequence Number | 047511 |
HICL Sequence Number Description | INSULIN GLARGINE-YFGN |
Brand/Generic | Generic |
Proprietary Name | Insulin Glargine |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | insulin glargine-yfgn |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION, SOLUTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 100 |
Active Ingredient Units | [iU]/mL |
Substance Name | INSULIN GLARGINE |
Labeler Name | Mylan Specialty L.P. |
Pharmaceutical Class | Insulin Analog [EPC], Insulin [CS] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA761201 |
Listing Certified Through | 2024-12-31 |
Package
NDC 49502-0394-75 (49502039475)
NDC Package Code | 49502-394-75 |
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Billing NDC | 49502039475 |
Package | 5 SYRINGE in 1 CARTON (49502-394-75) / 3 mL in 1 SYRINGE (49502-394-71) |
Marketing Start Date | 2021-11-16 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 5.89428 |
Pricing Unit | ML |
Effective Date | 2024-01-01 |
NDC Description | INSULIN GLARGINE-YFGN U100 PEN |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 4, 5, 6 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |