NDC Code(s) : 69292-015-35
Packager : Amici Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ganciclovirganciclovir GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-015
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GANCICLOVIR(UNII: P9G3CKZ4P5)
(GANCICLOVIR - UNII:P9G3CKZ4P5) 		GANCICLOVIR1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: HHT01ZNK31)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MANNITOL(UNII: 3OWL53L36A)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69292-015-351 in 1 CARTON 09/08/2017
15 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022211 09/08/2017

PRINCIPAL DISPLAY PANEL

ganciclovircarton.jpg

NDC 69292-015-35

Ganciclovir
Ophthalmic
Gel
0.15%

Sterile

FOR OPHTHALMIC
USE ONLY

Rx only

5 g

amici
pharmaceuticals