NDC Code(s) : 68071-4679-5
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ciprofloxacinCiprofloxacin SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-4679(NDC:69315-308)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE(UNII: 4BA73M5E37)
(CIPROFLOXACIN - UNII:5E8K9I0O4U) 		CIPROFLOXACIN3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE ANHYDROUS(UNII: NVG71ZZ7P0)
ACETIC ACID(UNII: Q40Q9N063P)
MANNITOL(UNII: 3OWL53L36A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-4679-55 mL in 1 BOTTLE Type 0: Not a Combination Product26/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077568 11/01/2018

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-4679)

PRINCIPAL DISPLAY PANEL

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