NDC Code(s) : 49349-389-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GemfibrozilGemfibrozil TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-389
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)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MAGNESIUM SULFATE, UNSPECIFIED(UNII: DE08037SAB)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score 2 pieces
Shape BULLET (TABLET) Size 20 mm
Flavor Imprint Code IG;225
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-389-0230 in 1 BLISTER PACK Type 0: Not a Combination Product27/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077836 04/27/2010 07/19/2011

PRINCIPAL DISPLAY PANEL

DRUG: Gemfibrozil

GENERIC: Gemfibrozil

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-389-02

STRENGTH:600 mg

COLOR: white

SHAPE: BULLET

SCORE: Two even pieces

SIZE: 20 mm

IMPRINT: 30

QTY: 30



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