NDC Code(s) : 48102-022-05
Packager : Fera Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GARAMYCIN GENTAMICIN SULFATE SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48102-022
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE(UNII: 8X7386QRLV)
(GENTAMICIN - UNII:T6Z9V48IKG) 		GENTAMICIN3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:48102-022-051 in 1 BOX
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065121 05/15/2011

PRINCIPAL DISPLAY PANEL




Garamycin Ophthalmic Solution Carton Label



FERA

NDC 48102-022-05

STERILE      Rx only

Garamycin®

gentamicin sulfate

Ophthalmic

Solution, USP, 0.3%


(equivalent to 3 mg

gentamicin base per mL)


FOR OPHTHALMIC USE ONLY

5mL

CF02202A
R0311

PRINCIPAL DISPLAY PANEL


Garamycin Ophthalmic Solution Bottle Label
FERA

NDC 48102-022-05

Garamycin®

gentamicin sulfate

Opthalmic Solution USP, 0.3%

(equivalent to 3 mg gentamicin base per mL)

FOR OPHTHALMIC USE ONLY

Sterile   5mL   Rx only