Gemfibrozil
- Product NDC
- 21695-732
- 11-digit product format
- 216950732
- Labeler code
- 21695
- Product ID
- 21695-732_d709812f-e958-4065-a447-c2c00ddd7677
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2010-11-09
- 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 |
|---|
| 21695-732-30 | Gemfibrozil | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 21695-732-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 21695-732-90 | Gemfibrozil | 90 in 1 BOTTLE | 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 [REBEL DISTRIBUTORS CORP] | 1 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-732 | GEMFIBROZIL TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20110314_d709812f-e958-4065-a447-c2c00ddd7677.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-732-30 | 21695073230 | 30 in 1 BOTTLE | Historical |
| 21695-732-60 | 21695073260 | 60 in 1 BOTTLE | Historical |
| 21695-732-90 | 21695073290 | 90 in 1 BOTTLE | Historical |