Levofloxacin

LEVOFLOXACIN — levofloxacin tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-691-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 250 mg

Rx only

50 tablets

Levofloxacin Tablets, 250 mg
(click image for full-size original)

NDC 65841-692-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 500 mg

Rx only

50 tablets

Levofloxacin Tablets, 500 mg
(click image for full-size original)

NDC 65841-693-18 in bottle of 50 tablets

Levofloxacin Tablets USP, 750 mg

Rx only

50 tablets

Levofloxacin Tablets, 750 mg
(click image for full-size original)
LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-691
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
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 15mm
Flavor Imprint Code ZC55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-691-18 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-691-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-691-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 11/10/2012
LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-692
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
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 19mm
Flavor Imprint Code ZC56
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-692-18 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-692-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-692-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-692-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 11/10/2010
LEVOFLOXACIN
levofloxacin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-693
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
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TALC
TITANIUM DIOXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE (MODIFIED CAPSULE) Size 22mm
Flavor Imprint Code ZC57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-693-18 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-693-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-693-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-693-92 20 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:65841-693-06 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077652 11/10/2012
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-691), ANALYSIS (65841-692), ANALYSIS (65841-693), MANUFACTURE (65841-691), MANUFACTURE (65841-692), MANUFACTURE (65841-693)

Revised: 01/2022 Cadila Healthcare Limited

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