Gemfibrozil
- Product NDC
- 0143-9130
- 11-digit product format
- 001439130
- Labeler code
- 0143
- Product ID
- 0143-9130_75e775c1-b2da-4b93-9dd8-1903de92fcc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- West-ward Pharmaceutical Corp
- Application
- ANDA077836
- Marketing category
- ANDA
- Marketing start
- 2006-07-27
- 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 |
|---|
| 0143-9130-05 | Gemfibrozil | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
| 0143-9130-60 | Gemfibrozil | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| METHYLCELLULOSE (1500 MPA.S) | INACTIVE INGREDIENT | P0NTE48364 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [MED-HEALTH PHARMA, LLC] | 3 | |
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| METHYLCELLULOSE (1500 MPA.S) | INACTIVE INGREDIENT | P0NTE48364 | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET [DISPENSING SOLUTIONS, INC.] | 2 | |
| GEMFIBROZIL | ACTIVE INGREDIENT | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| GEMFIBROZIL | ACTIVE MOIETY | Q8X02027X3 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| METHYLCELLULOSE (1500 MPA.S) | INACTIVE INGREDIENT | P0NTE48364 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9130 | GEMFIBROZIL TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] | 1 | Legacy NDC, 2 package rows | 20120110_c45cdbdb-414f-4bbf-a643-3a3d9de63a6b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0143-9130-05 | 00143913005 | 500 in 1 BOTTLE | Historical |
| 0143-9130-60 | 00143913060 | 60 in 1 BOTTLE | Historical |