NDC Code(s) : 54569-3695-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gemfibrozil Gemfibrozil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-3695(NDC:31722-225)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMFIBROZIL(UNII: Q8X02027X3)
(GEMFIBROZIL - UNII:Q8X02027X3) 		GEMFIBROZIL600 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CALCIUM STEARATE(UNII: 776XM7047L)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
METHYLCELLULOSE (15 CPS)(UNII: NPU9M2E6L8)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 225;IG
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-3695-012 in 1 CASE
160 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 01/01/2011

PRINCIPAL DISPLAY PANEL

NDC 54569-3695-0

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048


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