LEVOFLOXACIN (Page 16 of 16)

PACKAGE LABEL — LEVOFLOXACIN 500 MG TABLETS

Label Image
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LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-992(NDC:0093-7292)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN) LEVOFLOXACIN 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color orange (PEACH) Score no score
Shape OVAL Size 17mm
Flavor Imprint Code TEVA;7292
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-992-07 07 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:16590-992-10 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:16590-992-14 14 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076361 08/13/2011
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 08/2011 STAT RX USA LLC

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