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NDC 53002-1068-00 Gemfibrozil 600 mg/1 Details
Gemfibrozil 600 mg/1
Gemfibrozil is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is GEMFIBROZIL.
MedlinePlus Drug Summary
Gemfibrozil is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and triglycerides (other fatty substances) in the blood in certain people with very high triglycerides who are at risk of pancreatic disease (conditions affecting the pancreas, a gland that produces fluid to break down food and hormones to control blood sugar). Gemfibrozil is also used in people with a combination of low high-density lipoprotein (HDL; 'good cholesterol') levels and high low-density lipoprotein (LDL; 'bad cholesterol') and triglyceride levels to reduce the risk of heart disease. Gemfibrozil is in a class of lipid-regulating medications called fibrates. It works by reducing the production of triglycerides in the liver.
Related Packages: 53002-1068-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Gemfibrozil
Product Information
| NDC | 53002-1068 |
|---|---|
| Product ID | 53002-1068_563ede18-dec2-4b4b-ae86-ade1d4efda3d |
| Associated GPIs | 39200030000310 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Gemfibrozil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Gemfibrozil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | GEMFIBROZIL |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077836 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1068-00 (53002106800)
| NDC Package Code | 53002-1068-0 |
|---|---|
| Billing NDC | 53002106800 |
| Package | 100 TABLET in 1 BOTTLE (53002-1068-0) |
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |