Travoprost Ophthalmic Solution

Product NDC
68083-601
11-digit product format
680830601
Labeler code
68083
Product ID
68083-601_7c35e414-614e-4d70-96ff-3adae7238166
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA218159
Marketing category
ANDA
Marketing start
2024-07-12
Substance
TRAVOPROST
Active strength
.04 mg/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Travoprost Ophthalmic Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAVOPROST.04 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWJ68R08KX9
Rxcui284008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c9a16692-b67d-fe7d-e549-d5c422428aa8Product name520250305
d244df75-ee9e-4580-9b0c-1e61287c8253Product name120250102
52ddd23e-485b-499f-9fa1-f86549f4d9c0Product name220200605

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-601-01Travoprost Ophthalmic Solution2.5 mL in 1 BOTTLESOLUTION/ DROPS2.54
68083-601-01Travoprost Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-601TRAVOPROST OPHTHALMIC SOLUTION SOLUTION/ DROPS [GLAND PHARMA LIMITED]3Current NDC, 2 package rows20240717_71c9ea95-f577-411a-8e22-819e44d9680e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN71c9ea95-f577-411a-8e22-819e44d9680e4
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD71c9ea95-f577-411a-8e22-819e44d9680e4
284008travoprost 0.004 % Ophthalmic SolutionSY71c9ea95-f577-411a-8e22-819e44d9680e4
284008travoprost 40 MCG/ML Ophthalmic SolutionSY71c9ea95-f577-411a-8e22-819e44d9680e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-601-01680830601011 BOTTLE in 1 CARTON (68083-601-01) / 2.5 mL in 1 BOTTLE1 bottle2024-07-12NoNoCurrent