Prescription Drug Information: Levofloxacin (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levofloxacin Tablets, USP

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LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-637(NDC:33342-022)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYSORBATE 80
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color orange Score no score
Shape CAPSULE (capsule) Size 19mm
Flavor Imprint Code ML;63
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-637-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200839 03/22/2012
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-637)

Revised: 10/2019 PD-Rx Pharmaceuticals, Inc.

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