Moxifloxacin Hydrochloride (Page 17 of 17)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 43063-580-10

MOXIFLOXCIN HYDROCHLORIDE TABLETS

Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

Rx Only

image
(click image for full-size original)
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-580(NDC:47781-268)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN) MOXIFLOXACIN 400 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
Product Characteristics
Color red Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code BAYER;M400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-580-10 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021085 01/29/2014
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-580)

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

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