Gemfibrozil
- Product NDC
- 50090-2902
- 11-digit product format
- 500902902
- Labeler code
- 50090
- Product ID
- 50090-2902_6729ad44-0cd1-4ece-b075-958ad4199f33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2902-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-2 | 2023-02-07 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-3 | 2023-02-07 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-4 | 2023-02-07 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
| 50090-2902-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-b898-0266-e053-dadaa90a7c1a | d36ba323-f97f-4da8-9b98-ccdf3ac8d0df |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2902-0 | EA - Each | 50090-2902 | 00ffcba9-a4e1-42e2-a809-a8cea4a6733d | 1 | 2021-11-09 |
| 50090-2902-2 | EA - Each | 50090-2902 | 9bc7cae9-9cef-4ad4-b514-ca04ce10fb97 | 1 | 2021-11-09 |
| 50090-2902-3 | EA - Each | 50090-2902 | e2f7933b-dbe2-4fbc-b0d8-869527d11e69 | 1 | 2021-11-09 |
| 50090-2902-4 | EA - Each | 50090-2902 | e8f85093-a66e-4a6e-9990-afe0b8efc040 | 1 | 2021-11-09 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2902-0 | 50090290200 | 60 TABLET in 1 BOTTLE (50090-2902-0) | 60 tablet | 2017-03-04 | 0000-00-00 | No | No | Current |
| 50090-2902-2 | 50090290202 | 90 TABLET in 1 BOTTLE (50090-2902-2) | 90 tablet | 2017-03-04 | 0000-00-00 | No | No | Current |
| 50090-2902-3 | 50090290203 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-2902-3) | 30 tablet | 2016-10-13 | 0000-00-00 | No | No | Current |
| 50090-2902-4 | 50090290204 | 180 TABLET in 1 BOTTLE (50090-2902-4) | 180 tablet | 2017-03-04 | 0000-00-00 | No | No | Current |