Moxifloxacin Hydrochloride (Page 12 of 12)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 400 mg (30 Tablet Bottle)

Rising® NDC 57237-156-30

Moxifloxacin
Tablets, USP
400 mg
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.30 Tablets Rx only

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 400 mg (30 Tablet Bottle)
(click image for full-size original)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 400 mg (30 Tablet Bottle)
MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-156
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
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 4000
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color RED (Dull Red) Score no score
Shape CAPSULE (Modified Capsule Shaped) Size 17mm
Flavor Imprint Code E;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-156-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202632 03/04/2014
Labeler — Rising Health, LLC (080500961)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (57237-156), MANUFACTURE (57237-156)

Revised: 11/2019 Rising Health, LLC

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