Gemfibrozil
- Product NDC
- 33261-146
- 11-digit product format
- 332610146
- Labeler code
- 33261
- Product ID
- 33261-146_08efe152-6ce2-477a-9b41-0b3fe7abb8eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-146-30 | Gemfibrozil | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 33261-146-60 | Gemfibrozil | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 33261-146-90 | Gemfibrozil | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-146 | GEMFIBROZIL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 3 package rows | 20140110_1b1fa50e-6bb3-40d9-addc-48c37b8e1c49.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-146-30 | 33261014630 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-146-60 | 33261014660 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 33261-146-90 | 33261014690 | 90 in 1 BOTTLE, PLASTIC | Historical |