Gemfibrozil
- Product NDC
- 53002-2068
- 11-digit product format
- 530022068
- Labeler code
- 53002
- Product ID
- 53002-2068_ea557daa-08db-4a9b-9adf-08191743911f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- Marketing end
- 0000-00-00
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-2068-0 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-6 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-0 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-6 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-0 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-6 | 2020-12-16 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
| 53002-2068-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-384a-f424-e053-dadaa90a57ce | Gemfibrozil Tablets, USP Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2068-0 | Gemfibrozil | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 53002-2068-6 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2068 | GEMFIBROZIL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 2 package rows | 20230609_f20eb470-a6db-40c2-9113-8023eb0ea4d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-2068-0 | 53002206800 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-2068-0) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-2068-6 | 53002206806 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-2068-6) | 2018-10-01 | 0000-00-00 | No | No | Current |