Gemfibrozil
- Product NDC
- 60505-0034
- 11-digit product format
- 605050034
- Labeler code
- 60505
- Product ID
- 60505-0034_3b105431-f813-79be-f11c-5830de1f0afc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA075034
- Marketing category
- ANDA
- Marketing start
- 1998-10-01
- 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#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHYLCELLULOSE (15 MPA.S) | INACTIVE INGREDIENT | NPU9M2E6L8 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed RxNorm Mappings#