NDC Code(s) : 69097-282-70, 69097-282-07, 69097-289-70, 69097-289-07, 69097-287-81, 69097-287-07
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Levofloxacin Levofloxacin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-282
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN (Brownish-pink) Score no score
Shape OVAL (Biconvex) Size 13 mm
Flavor Imprint Code 250;C282
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-282-7050 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
2NDC:69097-282-07100 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076890 03/30/2012 03/21/2022
Levofloxacin Levofloxacin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-289
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (Biconvex) Size 17 mm
Flavor Imprint Code 500;C289
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-289-7050 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
2NDC:69097-289-07100 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076890 03/30/2012 03/21/2022
Levofloxacin Levofloxacin TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-287
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOFLOXACIN(UNII: 6GNT3Y5LMF)
(LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) 		LEVOFLOXACIN ANHYDROUS750 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (Biconvex) Size 20 mm
Flavor Imprint Code 750;C287
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-287-8120 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
2NDC:69097-287-07100 in 1 BOTTLE Type 0: Not a Combination Product30/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076890 03/30/2012

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd. Goa 650072015 MANUFACTURE(69097-282, 69097-289, 69097-287)

PRINCIPAL DISPLAY PANEL

RX ONLY

NDC 69097-282-70

Levofloxacin

Tablets, USP

250 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

50 Tablets (Brownish Pink)

Cipla

image -1image - 1

RX ONLY

NDC 69097-282-07

Levofloxacin

Tablets, USP

250 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

100 Tablets (Brownish Pink)

Cipla

image -1image - 2

RX ONLY

NDC 69097-289-70

Levofloxacin

Tablets, USP

500 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

50 Tablets (Yellow)

Cipla

image -1image - 3

RX ONLY

NDC 69097-289-07

Levofloxacin

Tablets, USP

500 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

100 Tablets (Yellow)

Cipla

image -1image - 4

RX ONLY

NDC 69097-287-81

Levofloxacin

Tablets, USP

750 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

20 Tablets (White)

Cipla

image -1image - 5

RX ONLY

NDC 69097-287-07                  

Levofloxacin

Tablets, USP

750 mg

Once-A-Day

PHARMACIST:

Please dispense with Medication Guide

100 Tablets (White)

Cipla

image -1image - 6