Gemfibrozil tablet, film coated

Ingredients and appearance - Product information

Gemfibrozil tablet, film coated- Gemfibrozil

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0615-3559
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Gemfibrozil ( UNII: Q8X02027X3)( Gemfibrozil - UNII: Q8X02027X3 ) 600 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium stearate ( UNII: 776XM7047L)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydroxypropyl cellulose (type h) ( UNII: RFW2ET671P)
Hypromellose 2910 (15 mpa.s) ( UNII: 36SFW2JZ0W)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polydextrose ( UNII: VH2XOU12IE)
Polyethylene glycol 4000 ( UNII: 4R4HFI6D95)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Starch, corn ( UNII: O8232NY3SJ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (white to off-white) Imprint Code 93;670
Score 2 Shape OVAL
Size 19 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA074256 USA

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs( 050052943)

Establishment

Name ID/FEI Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK( 0615-3559)
lipid values in mg/dL at baseline
P = placebo group; G = gemfibrozil group
difference in rates between placebo and gemfibrozil groups
fatal and nonfatal myocardial infarctions plus sudden cardiac deaths (events per 1000 patients over 5 years)
The six open-label groups are designated first by the original randomization (P = placebo, G = gemfibrozil) and then by the drug taken in the follow-up period (N = Attend clinic but took no drug, G = gemfibrozil, Drop = No attendance at clinic during open-label).
Intention-to-Treat Analysis of originally randomized patients neglecting the open-label treatment switches and exposure to study conditions.
Hazard ratio for risk event in the group originally randomized to gemfibrozil compared to the group originally randomized to placebo neglecting open-label treatment switch and exposure to study conditions.
95% confidence intervals of gemfibrozil:placebo group hazard ratio
Fatal and non-fatal myocardial infarctions plus sudden cardiac deaths over the 8.5 year period.