NDC Code(s) : 42571-382-71, 42571-382-73, 42571-382-27
Packager : Micro Labs Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-382
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DORZOLAMIDE HYDROCHLORIDE(UNII: QZO5366EW7)
(DORZOLAMIDE - UNII:9JDX055TW1) 		DORZOLAMIDE20 mg in 1 mL
TIMOLOL MALEATE(UNII: P8Y54F701R)
(TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42571-382-734 in 1 CARTON 23/03/2022
1NDC:42571-382-7115 in 1 POUCH
10.2 mL in 1 VIAL, SINGLE-USE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2NDC:42571-382-2712 in 1 CARTON 23/03/2022
215 in 1 POUCH
20.2 mL in 1 VIAL, SINGLE-USE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215936 02/15/2022

LABELER - Micro Labs Limited(862174955)

Establishment
Name Address ID/FEI Business Operations
Micro Labs Limited 677600482 analysis(42571-382), label(42571-382), manufacture(42571-382), pack(42571-382)

PRINCIPAL DISPLAY PANEL

Dorzolamide HCl and Timolol Maleate
Ophthalmic Solution, USP
2% / 0.5%
Preservative Free
For Use in the Eye
Rx only


dorzolamidetimolol-lbl.jpg


NDC 42571-382-71
Dorzolamide Hydrochloride
and Timolol Maleate
Ophthalmic Solution, USP
2% / 0.5%*
Preservative Free
For Topical Application in the Eye
Rx Only
15 Single-Use Containers
(0.2 mL in each container)
Micro Labs Limited


dorzolamidetimolol-lbl.jpg 


NDC 42571-382-73
Dorzolamide Hydrochloride
and Timolol Maleate
Ophthalmic Solution, USP
2% / 0.5%*
Preservative Free
For Topical Application in the Eye
Rx Only
60 Single-Use Containers:
4 pouches x 15 Single-Use Containers
(0.2 mL in each single-use container)
Micro labs Limited

dorzolamidetimolol-lbl.jpg