Ciprofloxacin Extended-release (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10370-107-05
Ciprofloxacin
Extended-Release Tablets
500 mg
50-count, 100-count and 500-countRx Only

434b702d-figure-03
(click image for full-size original)

NDC 10370-108-05
Ciprofloxacin
Extended-Release Tablets
1000 mg
50-count and 100-countRx Only

434b702d-figure-04
(click image for full-size original)
CIPROFLOXACIN EXTENDED-RELEASE ciprofloxacin tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 574.9 mg
CIPROFLOXACIN (CIPROFLOXACIN) CIPROFLOXACIN 425.2 mg
Inactive Ingredients
Ingredient Name Strength
TRIACETIN
SILICON DIOXIDE
CROSPOVIDONE
D&C YELLOW NO. 10
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
LACTITOL
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
SUCCINIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code ANCHEN;108
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10370-108-05 50 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:10370-108-10 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078166 08/05/2011
CIPROFLOXACIN EXTENDED-RELEASE ciprofloxacin tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 212.6 mg
CIPROFLOXACIN (CIPROFLOXACIN) CIPROFLOXACIN 287.5 mg
Inactive Ingredients
Ingredient Name Strength
TRIACETIN
SILICON DIOXIDE
CROSPOVIDONE
D&C YELLOW NO. 10
HYDROGENATED COTTONSEED OIL
HYPROMELLOSES
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
SUCCINIC ACID
MAGNESIUM STEARATE
LACTITOL
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code ANCHEN;107
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10370-107-05 50 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
2 NDC:10370-107-10 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
3 NDC:10370-107-50 500 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078166 08/05/2011
Labeler — Par Pharmaceuticals, Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Anchen Pharmaceuticals, Inc. 122678886 MANUFACTURE (10370-108), ANALYSIS (10370-108), MANUFACTURE (10370-107), ANALYSIS (10370-107)
Establishment
Name Address ID/FEI Operations
Par Pharmaceuticals, Inc. 092733690 PACK (10370-108), PACK (10370-107)

Revised: 12/2012 Par Pharmaceuticals, Inc.

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