Moxifloxacin (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Unvarnished Area Consits of: 2D Barcode, Lot Number, Expiry Date and Serial Number

Container label : 30’s count

container
(click image for full-size original)

Blister Carton Label: 50 Unit Dose Tablets (5 X 10)

carton
(click image for full-size original)
MOXIFLOXACIN moxifloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-112
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-112-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:55111-112-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:55111-112-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:55111-112-66 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-112-79)
4 NDC:55111-112-79 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (55111-112-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076938 03/05/2014
Labeler — Dr. Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited (FTO-III) 918608162 manufacture (55111-112), analysis (55111-112)

Revised: 12/2020 Dr. Reddy’s Laboratories Limited

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