Gemfibrozil
- Product NDC
- 51138-588
- 11-digit product format
- 511380588
- Labeler code
- 51138
- Product ID
- 51138-588_fdf6ae68-5234-4aac-ab0d-38fa7e87f7a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Med-Health Pharma, LLC
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2011-07-04
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 51138-588-30 | Gemfibrozil | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| METHYLCELLULOSE (1500 MPA.S) | INACTIVE INGREDIENT | P0NTE48364 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51138-588 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | Legacy NDC, 1 package rows | 20120216_b57eeb99-679e-4136-80f4-85421e21400b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 51138-588-30 | 51138058830 | 30 in 1 BOTTLE, PLASTIC | Historical |