Ciprofloxacin (Page 12 of 12)

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

NDC 59651-866-30
Rx only
Ciprofloxacin Tablets, USP
250 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELYAUROBINDO 30 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 250 mg (30 Tablets Bottle)
(click image for full-size original)

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

NDC 59651-867-30
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)
(click image for full-size original)

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

NDC 59651-873-50
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)
(click image for full-size original)

CIPROFLOXACIN ciprofloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-866
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code L53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-866-20 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59651-866-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59651-866-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:59651-866-99 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 02/09/2024
CIPROFLOXACIN ciprofloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-867
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (White to Off-white) Score 2 pieces
Shape CAPSULE Size 18mm
Flavor Imprint Code L54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-867-20 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59651-867-30 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59651-867-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:59651-867-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:59651-867-99 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 02/09/2024
CIPROFLOXACIN ciprofloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-873
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
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:59651-873-20 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59651-873-50 50 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59651-873-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:59651-873-05 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:59651-873-98 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 02/09/2024
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (59651-866), ANALYSIS (59651-867), ANALYSIS (59651-873), MANUFACTURE (59651-866), MANUFACTURE (59651-867), MANUFACTURE (59651-873)

Revised: 03/2024 Aurobindo Pharma Limited

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