NDC Code(s) : 0378-9651-32, 0378-9651-50
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Travoprost Ophthalmic Solution, 0.004%Travoprost Ophthalmic Solution, 0.004% SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-9651
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAVOPROST(UNII: WJ68R08KX9)
(TRAVOPROST - UNII:WJ68R08KX9) 		TRAVOPROST0.04 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
BORIC ACID(UNII: R57ZHV85D4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SORBITOL(UNII: 506T60A25R)
ZINC CHLORIDE(UNII: 86Q357L16B)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-9651-321 in 1 CARTON 18/12/2019
12.5 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0378-9651-501 in 1 CARTON 18/12/2019
25 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205050 12/18/2019

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 0378-9651-32

Travoprost Ophthalmic Solution, USP

0.004% (Ionic Buffered Solution)

FOR USE IN THE EYES ONLY

Rx only

Mylan

2.5 mL

Carton 2.5 mL

PRINCIPAL DISPLAY PANEL

NDC 0378-9651-50

Travoprost Ophthalmic Solution, USP

0.004% (Ionic Buffered Solution)

FOR USE IN THE EYES ONLY

Rx only

Mylan

5 mL

Carton 5 mL