Gemfibrozil
- Product NDC
- 65862-624
- 11-digit product format
- 658620624
- Labeler code
- 65862
- Product ID
- 65862-624_9dfb61ff-d04d-4c5f-85e6-c9dfae7c395e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202726
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- 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 |
|---|
| 65862-624-05 | Gemfibrozil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 9 |
| 65862-624-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-624 | GEMFIBROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240516_a68f430e-7c98-4bd9-8902-758706713996.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 |
|---|
| 65862-624-05 | 65862062405 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-624-05) | 2015-09-16 | 0000-00-00 | No | No | Current |
| 65862-624-22 | 65862062422 | 2000 TABLET, FILM COATED in 1 BAG (65862-624-22) | 16-SEP-15 | | | | Current |
| 65862-624-60 | 65862062460 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-624-60) | 2015-09-16 | 0000-00-00 | No | No | Current |