Gemfibrozil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is Gemfibrozil.
| Product ID | 75834-131_46c22ec0-5ec6-472c-a8cf-b89c27dc6448 |
| NDC | 75834-131 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gemfibrozil |
| Generic Name | Gemfibrozil |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-15 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203266 |
| Labeler Name | Nivagen Pharmaceuticals, Inc. |
| Substance Name | GEMFIBROZIL |
| Active Ingredient Strength | 600 mg/1 |
| Pharm Classes | PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-02-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203266 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-15 |
| Marketing Category | ANDA |
| Application Number | ANDA203266 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-15 |
| Marketing Category | ANDA |
| Application Number | ANDA203266 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-15 |
| Ingredient | Strength |
|---|---|
| GEMFIBROZIL | 600 mg/1 |
| SPL SET ID: | a086fc16-e6f3-47fd-b577-7c611e735834 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0670 | Gemfibrozil | Gemfibrozil |
| 0143-9130 | Gemfibrozil | Gemfibrozil |
| 0143-9707 | Gemfibrozil | Gemfibrozil |
| 0179-0221 | Gemfibrozil | Gemfibrozil |
| 0615-3559 | Gemfibrozil | Gemfibrozil |
| 0615-8354 | Gemfibrozil | Gemfibrozil |
| 10544-569 | Gemfibrozil | Gemfibrozil |
| 16571-784 | Gemfibrozil | Gemfibrozil |
| 16714-101 | Gemfibrozil | gemfibrozil |
| 21695-732 | Gemfibrozil | Gemfibrozil |
| 24658-260 | Gemfibrozil | Gemfibrozil |
| 31722-128 | GEMFIBROZIL | Gemfibrozil |
| 31722-225 | Gemfibrozil | Gemfibrozil |
| 33261-146 | Gemfibrozil | Gemfibrozil |
| 42806-260 | GEMFIBROZIL | GEMFIBROZIL |
| 43063-745 | Gemfibrozil | Gemfibrozil |
| 43063-921 | GEMFIBROZIL | GEMFIBROZIL |
| 43353-090 | Gemfibrozil | Gemfibrozil |
| 43353-772 | Gemfibrozil | Gemfibrozil |
| 43602-452 | GEMFIBROZIL | Gemfibrozil |
| 50090-0458 | Gemfibrozil | Gemfibrozil |
| 50090-2450 | Gemfibrozil | Gemfibrozil |
| 50090-2902 | Gemfibrozil | Gemfibrozil |
| 50090-5808 | GEMFIBROZIL | Gemfibrozil |
| 50268-350 | Gemfibrozil | Gemfibrozil |
| 68071-1733 | Gemfibrozil | Gemfibrozil |
| 68071-4053 | GEMFIBROZIL | GEMFIBROZIL |
| 68071-4011 | GEMFIBROZIL | GEMFIBROZIL |
| 68071-4631 | Gemfibrozil | Gemfibrozil |
| 68071-4421 | Gemfibrozil | Gemfibrozil |
| 68151-2893 | Gemfibrozil | Gemfibrozil |
| 68382-553 | Gemfibrozil | Gemfibrozil |
| 68788-6447 | Gemfibrozil | Gemfibrozil |
| 68788-7011 | GEMFIBROZIL | GEMFIBROZIL |
| 68788-9149 | Gemfibrozil | Gemfibrozil |
| 69097-821 | Gemfibrozil | Gemfibrozil |
| 70518-1563 | Gemfibrozil | Gemfibrozil |
| 70518-1301 | Gemfibrozil | Gemfibrozil |
| 70771-1431 | Gemfibrozil | Gemfibrozil |
| 71205-169 | Gemfibrozil | Gemfibrozil |
| 71209-008 | Gemfibrozil | Gemfibrozil |
| 71335-0051 | GEMFIBROZIL | GEMFIBROZIL |
| 71335-0971 | Gemfibrozil | Gemfibrozil |
| 71335-0899 | Gemfibrozil | Gemfibrozil |
| 71335-0515 | Gemfibrozil | Gemfibrozil |
| 71610-200 | Gemfibrozil | Gemfibrozil |
| 71610-107 | Gemfibrozil | Gemfibrozil |
| 75834-131 | Gemfibrozil | Gemfibrozil |
| 76282-225 | Gemfibrozil | Gemfibrozil |
| 50436-6540 | Gemfibrozil | Gemfibrozil |