Levofloxacin (Page 17 of 17)

Package/Label Display Panel

63187-003-07
(click image for full-size original)

Package/Label Display Panel

63187-004-10
(click image for full-size original)
LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-003(NDC:0781-5791)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OCTAGON (8 sided) Size 18mm
Flavor Imprint Code SZ;986
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-003-10 10 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077438 06/20/2011
LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-004(NDC:0781-5792)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OCTAGON (8 sided) Size 20mm
Flavor Imprint Code SZ;987
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-004-10 10 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077438 06/20/2011
Labeler — Proficient Rx (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx 079196022 RELABEL (63187-003), RELABEL (63187-004), REPACK (63187-003), REPACK (63187-004)

Revised: 12/2019 Proficient Rx

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