Tafluprost Ophthalmic Solution, 0.0015%

Tafluprost by

Drug Labeling and Warnings

Tafluprost by is a Prescription medication manufactured, distributed, or labeled by The Ritedose Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TAFLUPROST- tafluprost solution 
The Ritedose Corporation

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Tafluprost Ophthalmic Solution, 0.0015%

NDC: 0781-6184-87

Tafluprost Ophthalmic Solution 0.0015%

Single-Use Containers

Preservative-Free, Sterile

For Topical Application in the Eye

REFRIGERATE (2° to 8°C or 36° to 46°F)

Rx Only

30 Single-Use Containers:

6 Pouches x 5 Single-Use Containers

(0.3 mL each)

Sandoz A Novartis Division

Tafluprost Ophthalmic Solution, 0.0015% Carton

TAFLUPROST 
tafluprost solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 65302-062
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TAFLUPROST (UNII: 1O6WQ6T7G3) (TAFLUPROST - UNII:1O6WQ6T7G3)	TAFLUPROST	0.0045 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROCHLORIC ACID (UNII: QTT17582CB)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65302-062-05	6 in 1 CARTON	12/05/2022
1		5 in 1 POUCH
1		0.3 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209040	12/05/2022

Labeler - The Ritedose Corporation (837769546)

Establishment
Name	Address	ID/FEI	Business Operations
The Ritedose Corporation		837769546	analysis(65302-062) , label(65302-062) , manufacture(65302-062) , pack(65302-062)

Revised: 12/2022

Document Id: f05e2b3e-be98-5187-e053-2a95a90a1067

34391-3

Set id: f05e2b3e-be97-5187-e053-2a95a90a1067

Version: 1

Effective Time: 20221221