Gemfibrozil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Gemfibrozil.
| Product ID | 53002-2068_8d5197fc-5b3f-413a-8e8a-c04ddc378d34 |
| NDC | 53002-2068 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gemfibrozil |
| Generic Name | Gemfibrozil |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-09-16 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202726 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Substance Name | GEMFIBROZIL |
| Active Ingredient Strength | 600 mg/1 |
| Pharm Classes | Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202726 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Marketing Category | ANDA |
| Application Number | ANDA202726 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| GEMFIBROZIL | 600 mg/1 |
| SPL SET ID: | f20eb470-a6db-40c2-9113-8023eb0ea4d2 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| 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 |