Moxifloxacin Hydrochloride (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Moxifloxacin Hydrochloride Tablets

Container Label

container
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Blister Label

blister
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Carton Label

carton
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MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-034
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
HYPROMELLOSES
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color PINK Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code n;034
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-034-03 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:40032-034-05 500 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:40032-034-31 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (40032-034-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207285 02/13/2017
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-034), MANUFACTURE (40032-034)

Revised: 12/2019 Novel Laboratories, Inc.

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