NDC Code(s) : 43063-547-79, 43063-547-02, 43063-547-03, 43063-547-04, 43063-547-06, 43063-547-10, 43063-547-14, 43063-547-20, 43063-547-28, 43063-547-30, 43063-547-01, 43063-547-82
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CiprofloxacinCiprofloxacin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-547(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
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)
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:43063-547-791 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product31/08/2015
2NDC:43063-547-022 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/06/2015
3NDC:43063-547-033 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/01/2016
4NDC:43063-547-044 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/11/2015
5NDC:43063-547-066 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/07/2015
6NDC:43063-547-1010 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/05/2014
7NDC:43063-547-1414 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/08/2015
8NDC:43063-547-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/05/2014
9NDC:43063-547-2828 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/12/2017
10NDC:43063-547-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/05/2014
11NDC:43063-547-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/07/2019
12NDC:43063-547-82500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076126 10/10/2009

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-547)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – 500 mg Bottle Label

CIPROFLOXACIN

Tablets USP

500 mg

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE.

Rx Only

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