Ciprofloxacin: Package Insert and Label Information (Page 8 of 8)

Package/Label Display Panel – Carton – 250 mg

250 mg Ciprofloxacin Tablets Carton

NDC 60687- 528 -01

Ciprofloxacin
Tablets USP

250 mg

100 Tablets (10 x 10            Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Ciprofloxacin Hydrochloride USP equivalent to 250 mg of
ciprofloxacin.

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 16571-411, Rising Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

752801 0452801/1019

Package/Label Display Panel – Blister – 250 mg

250 mg Ciprofloxacin Tablet Blister
(click image for full-size original)

Ciprofloxacin
Tablet USP 250 mg

Package/Label Display Panel – Carton – 500 mg

500 mg Ciprofloxacin Tablets Carton
(click image for full-size original)

NDC 60687- 539 -01

Ciprofloxacin
Tablets USP

500 mg

100 Tablets (10 x 10)            Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Ciprofloxacin Hydrochloride USP equivalent to 500 mg of
ciprofloxacin.

Usual Dosage: See package insert for full prescribing
information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled
Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or
broken.

The drug product contained in this package is from
NDC # 16571-412, Rising Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

753901 0453901/1019

Package/Label Display Panel – Blister – 500 mg

500 mg Ciprofloxacin Tablet Blister
(click image for full-size original)

Ciprofloxacin
Tablet USP 500 mg

CIPROFLOXACIN ciprofloxacin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-528(NDC:16571-411)
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
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND (circular) Size 11mm
Flavor Imprint Code P;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-528-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-528-11)
1 NDC:60687-528-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-528-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076639 03/19/2020
CIPROFLOXACIN ciprofloxacin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60687-539(NDC:16571-412)
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
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code P;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60687-539-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (60687-539-11)
1 NDC:60687-539-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (60687-539-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076639 03/19/2020
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (60687-528), repack (60687-539)

Revised: 03/2020 American Health Packaging

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