NDC Code(s) : 49349-036-02, 49349-036-03
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ciprofloxacin HydrochlorideCiprofloxacin Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-036
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
HYDRATED SILICA(UNII: Y6O7T4G8P9)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape OVAL (TABLET) Size 16 mm
Flavor Imprint Code WW;928
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-036-0230 in 1 BLISTER PACK Type 0: Not a Combination Product09/07/2009
2NDC:49349-036-0320 in 1 BLISTER PACK Type 0: Not a Combination Product28/07/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076558 07/06/2009 10/19/2010

PRINCIPAL DISPLAY PANEL

DRUG: Ciprofloxacin Hydrochloride

GENERIC: Ciprofloxacin Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-036-02

STRENGTH:500 mg

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: WW;928

QTY: 30



IMAGE OF PRODUCT LABEL

PRINCIPAL DISPLAY PANEL

DRUG: Ciprofloxacin Hydrochloride

GENERIC: Ciprofloxacin Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-036-03

STRENGTH:500 mg

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 16 mm

IMPRINT: WW;928

QTY: 20



IMAGE OF PRODUCT LABEL 2IMAGE OF PRODUCT LABEL 2