LEVOFLOXACIN (Page 15 of 15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levofloxacin Tablets 250 mg, 500s count

250 mg
(click image for full-size original)

Levofloxacin Tablets 500 mg, 500s count

500 Mg
(click image for full-size original)

Levofloxacin Tablets 750 mg, 500s count

750 Mg
(click image for full-size original)
LEVOFLOXACIN levofloxacin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-082
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
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE
Product Characteristics
Color pink (light pink) Score no score
Shape CAPSULE (capsule-shaped) Size 13mm
Flavor Imprint Code 250;1082
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-082-05 500 TABLET in 1 BOTTLE None
2 NDC:13668-082-01 100 TABLET in 1 BOTTLE None
3 NDC:13668-082-50 50 TABLET in 1 BOTTLE None
4 NDC:13668-082-74 100 TABLET in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090722 06/20/2011
LEVOFLOXACIN levofloxacin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-083
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
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE
Product Characteristics
Color red (brick red) Score no score
Shape CAPSULE (capsule-shaped) Size 16mm
Flavor Imprint Code 83
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-083-74 100 TABLET in 1 CARTON None
2 NDC:13668-083-05 500 TABLET in 1 BOTTLE None
3 NDC:13668-083-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-083-50 50 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090722 06/20/2011
LEVOFLOXACIN levofloxacin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-084
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
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYSORBATE 80
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
CROSPOVIDONE
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (capsule-shaped) Size 20mm
Flavor Imprint Code 750;1084
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-084-74 100 TABLET in 1 CARTON None
2 NDC:13668-084-05 500 TABLET in 1 BOTTLE None
3 NDC:13668-084-01 100 TABLET in 1 BOTTLE None
4 NDC:13668-084-50 50 TABLET in 1 BOTTLE None
5 NDC:13668-084-21 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090722 06/20/2011
Labeler — Torrent Pharmaceuticals Limited (916488547)
Registrant — Torrent Pharma, Inc. (790033935)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture (13668-082), manufacture (13668-083), manufacture (13668-084)

Revised: 02/2021 Torrent Pharmaceuticals Limited

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