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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL –

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CIPROFLOXACIN ciprofloxacin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4627(NDC:65862-077)
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Off-white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code C;94
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-4627-2 2 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-4627-4 4 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68071-4627-6 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 04/26/2007
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-4627)

Revised: 08/2022 NuCare Pharmaceuticals,Inc.

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