Moxifloxacin Hydrochloride Tablets, 400 Mg (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label — 30’s count

30s-cntnr
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Container Label — 500’s count
500s-cntnr
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Blister Pack Carton Label — 50’s (5 x 10 Unit dose tablets)
crtn
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Blister-foil
foil
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MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG moxifloxacin hydrochloride tablets, 400 mg tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE (MOXIFLOXACIN) MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 400 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POVIDONE K30
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
HYPROMELLOSES
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code M;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-001-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:72205-001-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:72205-001-31 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-001-11)
3 NDC:72205-001-11 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (72205-001-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208682 07/21/2018
Labeler — Novadoz Pharmaceuticals LLC (081109687)
Registrant — Novadoz Pharmaceuticals LLC (081109687)
Establishment
Name Address ID/FEI Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS (72205-001), MANUFACTURE (72205-001)

Revised: 04/2019 Novadoz Pharmaceuticals LLC

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