Gemfibrozil
- Product NDC
- 55700-493
- 11-digit product format
- 557000493
- Labeler code
- 55700
- Product ID
- 55700-493_d592200f-e309-4e59-a6b2-35cfe849de69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-10-13
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-493-30 | 2025-01-09 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
| 55700-493-60 | 2025-01-09 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
| 55700-493-90 | 2025-01-09 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
| 55700-493-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
| 55700-493-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
| 55700-493-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2afc-111a-e063-dadaa90a10e2 | 90412982-0498-4f0e-be87-dd88c108e06e |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-493-30 | EA - Each | 55700-493 | a4be72d7-aab6-4faf-a21e-f71dc9497e80 | 1 | 2017-03-06 |
| 55700-493-60 | EA - Each | 55700-493 | eaddae5c-27b6-4a87-b599-86bac35aba2a | 1 | 2018-01-12 |
| 55700-493-90 | EA - Each | 55700-493 | 8b306138-f6db-4993-9fe0-32aa41897044 | 1 | 2017-06-15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-493-90 | 55700049390 | 90 TABLET in 1 BOTTLE (55700-493-90) | 90 tablet | 2017-02-06 | 0000-00-00 | No | No | Current |