NDC Code(s) : 72485-630-05
Packager : ARMAS PHARMACEUTICALS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Loteprednol EtabonateLoteprednol Etabonate GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-630
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOTEPREDNOL ETABONATE(UNII: YEH1EZ96K6)
(LOTEPREDNOL - UNII:Z8CBU6KR16) 		LOTEPREDNOL ETABONATE5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BORIC ACID(UNII: R57ZHV85D4)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
POLYCARBOPHIL(UNII: W25LM17A4W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TYLOXAPOL(UNII: Y27PUL9H56)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72485-630-051 in 1 CARTON 25/10/2023
15 g in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212080 10/25/2023

LABELER - ARMAS PHARMACEUTICALS INC.(098405973)

REGISTRANT - SENTISS AG(486920486)

Establishment
Name Address ID/FEI Business Operations
Ophtapharm AG 482198285 manufacture(72485-630), label(72485-630), pack(72485-630), analysis(72485-630)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 72485-630-05

Loteprednol

Etabonate

Ophthalmic Gel

0.5%

FOR USE IN THE EYES ONLY

Rx only Sterile 5 g

container

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 72485-630-05

Loteprednol

Etabonate

Ophthalmic Gel

0.5%

FOR USE IN THE EYES ONLY

Sterile

5 g

Rx only

carton