Gemfibrozil

Product NDC
63187-146
11-digit product format
631870146
Labeler code
63187
Product ID
63187-146_e9f3d596-be8b-47ed-9982-5c26878e3def
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077836
Marketing category
ANDA
Marketing start
2011-01-01
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [PROFICIENT RX LP]2
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [PROFICIENT RX LP]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82GEMFIBROZIL TABLET [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6GEMFIBROZIL TABLET [PROFICIENT RX LP]2
METHYLCELLULOSE (15 MPA.S)INACTIVE INGREDIENTNPU9M2E6L8GEMFIBROZIL TABLET [PROFICIENT RX LP]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGEMFIBROZIL TABLET [PROFICIENT RX LP]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGEMFIBROZIL TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-146GEMFIBROZIL TABLET [PROFICIENT RX LP]3Legacy NDC20191212_2b916bf7-1c69-412a-8dab-40294d34df2d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-146-306318701463030 TABLET in 1 BOTTLE (63187-146-30) 30 tablet2014-08-010000-00-00NoNoCurrent
63187-146-7863187014678180 TABLET in 1 BOTTLE (63187-146-78) 180 tablet2014-08-010000-00-00NoNoCurrent