Gemfibrozil
- Product NDC
- 43353-090
- 11-digit product format
- 433530090
- Labeler code
- 43353
- Product ID
- 43353-090_885cf4de-06f5-4acc-8feb-f61e7642b366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2010-03-12
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-090-60 | Gemfibrozil | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 43353-090-80 | Gemfibrozil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-090 | GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 2 package rows | 20140517_78ec73e1-6420-467f-8496-042d8d9a1d0b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-090-60 | 43353009060 | 90 in 1 BOTTLE | Historical |
| 43353-090-80 | 43353009080 | 180 in 1 BOTTLE | Historical |