Ciprofloxacin (Page 13 of 13)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 250 mg (100 Tablets Bottle)

Rx only
NDC 16714-651-02
Ciprofloxacin
Tablets, USP
250 mg
PHARMACIST: PLEASE DISPENSE
WITH MEDICATION GUIDE PROVIDED
SEPARATELY.
100 Tablets
Nothstar Rx®

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (100 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 500 mg (100 Tablets Bottle)

Rx only NDC 16714-652-02
Ciprofloxacin
Tablets, USP
500 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY.
100 Tablets
Northstar Rx®

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 500 mg (100 Tablets Bottle)
(click image for full-size original)

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

Rx only
NDC 16714-653-01
Ciprofloxacin
Tablets, USP
750 mg
PHARMACIST: PLEASE DISPENSE
WITH MEDICATION GUIDE PROVIDED
SEPARATELY.
50 Tablets Northstar Rx®

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 750 mg (50 Tablets Bottle)
(click image for full-size original)

CIPROFLOXACIN ciprofloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-651
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code C;95
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-651-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-651-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16714-651-03 1000 TABLET, FILM COATED in 1 BOTTLE None
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 Item Code (Source) NDC:16714-652
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 500 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (Whit to Off-white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code C;94
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-652-01 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16714-652-02 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16714-652-04 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:16714-652-03 1000 TABLET, FILM COATED in 1 BOTTLE None
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 Item Code (Source) NDC:16714-653
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 750 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code C;93
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-653-01 50 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 04/26/2007
Labeler — NorthStar Rx LLC (830546433)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (16714-651), ANALYSIS (16714-652), ANALYSIS (16714-653), MANUFACTURE (16714-651), MANUFACTURE (16714-652), MANUFACTURE (16714-653)

Revised: 07/2020 NorthStar Rx LLC

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