NDC Code(s) : 65862-076-20, 65862-076-30, 65862-076-01, 65862-076-99, 65862-077-20, 65862-077-30, 65862-077-01, 65862-077-05, 65862-077-99, 65862-078-20, 65862-078-50, 65862-078-01, 65862-078-05, 65862-078-98
Packager : Aurobindo Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-076
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE(UNII: 4BA73M5E37)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code C;95
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-076-2020 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
2NDC:65862-076-3030 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
3NDC:65862-076-01100 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
4NDC:65862-076-991000 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 04/26/2007
Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-077
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE(UNII: 4BA73M5E37)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code C;94
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-077-2020 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
2NDC:65862-077-3030 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
3NDC:65862-077-01100 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
4NDC:65862-077-05500 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
5NDC:65862-077-991000 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 04/26/2007
Ciprofloxacin Ciprofloxacin Hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:65862-078
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE(UNII: 4BA73M5E37)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K30(UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code C;93
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65862-078-2020 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
2NDC:65862-078-5050 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
3NDC:65862-078-01100 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
4NDC:65862-078-05500 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
5NDC:65862-078-981000 in 1 BOTTLE Type 0: Not a Combination Product26/04/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 04/26/2007

LABELER - Aurobindo Pharma Limited(650082092)

Establishment
Name Address ID/FEI Business Operations
Aurobindo Pharma Limited 918917642 ANALYSIS(65862-076, 65862-077, 65862-078), MANUFACTURE(65862-076, 65862-077, 65862-078)

PRINCIPAL DISPLAY PANEL


NDC 65862-076-30
Rx only
Ciprofloxacin Tablets, USP
250 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
AUROBINDO                               30 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (30 Tablet Bottle)

PRINCIPAL DISPLAY PANEL

NDC 65862-077-30
 Rx only
 Ciprofloxacin Tablets, USP
 500 mg
 PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
 AUROBINDO                                       30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (30 Tablets Bottle)

PRINCIPAL DISPLAY PANEL

NDC 65862-078-50
Rx only
 Ciprofloxacin Tablets, USP
 750 mg
 PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
 AUROBINDO                                      50 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 mg (50 Tablets Bottle)