Levofloxacin (Page 15 of 15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL (500mg 50 ct Bottle)

NDC 52343-120-50
Levofloxacin Tablets
500 mg
Rx only 50 TabletsAcetris Health, LLC

levo500mg
(click image for full-size original)

levo500mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL (250mg 50 ct Bottle)

NDC 52343-119-50
Levofloxacin Tablets
250 mg
Rx only 50 TabletsAcetris Health, LLC

levo250mg
(click image for full-size original)

levo250mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL (750mg 20 ct Bottle)

NDC 52343-121-20
Levofloxacin Tablets
750 mg
Rx only 20 TabletsAcetris Health, LLC

levo750mg
(click image for full-size original)
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-119
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (Terra Pink) Score no score
Shape CAPSULE (Biconvex) Size 15mm
Flavor Imprint Code 13;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52343-119-50 50 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201043 06/20/2011
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-120
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE (Biconvex) Size 19mm
Flavor Imprint Code 12;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52343-120-50 50 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201043 06/20/2011
LEVOFLOXACIN levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52343-121
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN (LEVOFLOXACIN ANHYDROUS) LEVOFLOXACIN ANHYDROUS 750 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE (Biconvex) Size 22mm
Flavor Imprint Code 11;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52343-121-20 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201043 06/20/2011
Labeler — ACETRIS HEALTH, LLC (080500964)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE (52343-119), MANUFACTURE (52343-120), MANUFACTURE (52343-121)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917626 API MANUFACTURE (52343-119), API MANUFACTURE (52343-120), API MANUFACTURE (52343-121)

Revised: 10/2019 ACETRIS HEALTH, LLC

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