NDC Code(s) : 55700-481-14
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CiprofloxacinCiprofloxacin Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-481(NDC:61442-223)
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
HYPROMELLOSE 2208 (15000 MPA.S)(UNII: Z78RG6M2N2)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white (white) Score no score
Shape OVAL (OVAL) Size 18 mm
Flavor Imprint Code CTI;223
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-481-1414 in 1 BOTTLE Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076126 10/10/2009

PRINCIPAL DISPLAY PANEL

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