Gemfibrozil
- Product NDC
- 76282-225
- 11-digit product format
- 762820225
- Labeler code
- 76282
- Product ID
- 76282-225_9d0b053e-d825-4af2-b923-35d7709da23e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2006-10-20
- 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 |
|---|
| 76282-225-05 | Gemfibrozil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 76282-225-18 | Gemfibrozil | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 8 |
| 76282-225-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| METHYLCELLULOSE (15 CPS) | INACTIVE INGREDIENT | NPU9M2E6L8 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-225 | GEMFIBROZIL TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20210622_5c09fe54-697e-4cd5-9a26-7c9c7fa9a864.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76282-225-05 | 76282022505 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-225-05) | 2006-10-20 | 0000-00-00 | No | No | Current |
| 76282-225-18 | 76282022518 | 180 TABLET, FILM COATED in 1 BOTTLE (76282-225-18) | 2006-10-20 | 0000-00-00 | No | No | Current |
| 76282-225-60 | 76282022560 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-225-60) | 2006-10-20 | 0000-00-00 | No | No | Current |