Gemfibrozil
- Product NDC
- 43063-745
- 11-digit product format
- 430630745
- Labeler code
- 43063
- Product ID
- 43063-745_3ef18652-9145-bc21-e063-6394a90a74fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2016-10-13
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gemfibrozil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 310459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-745-60 | Gemfibrozil | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 18 |
| 43063-745-93 | Gemfibrozil | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-745 | GEMFIBROZIL TABLET [PD-RX PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241016_5501438d-5247-4f2a-8e15-085276d01725.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-745-60 | 43063074560 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60) | 60 tablet | 2017-02-09 | 0000-00-00 | No | No | Current |
| 43063-745-93 | 43063074593 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93) | 180 tablet | 2017-12-12 | 0000-00-00 | No | No | Current |