FDA.reportPublic FDA data

Travatan Z

Product NDC
66758-095
11-digit product format
667580095
Labeler code
66758
Product ID
66758-095_89518acb-1d44-48cc-aa2e-bcb2022ff0c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
travoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA021994
Marketing category
NDA
Marketing start
2006-10-20
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
Travatan Z
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAVOPROST.04 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWJ68R08KX9
Rxcui284008, 285032

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
66758-095-56Travatan Z2.5 mL in 1 BOTTLESOLUTION/ DROPS2.53
66758-095-56Travatan Z1 in 1 CARTONSOLUTION/ DROPS13
66758-095-75Travatan Z5 mL in 1 BOTTLESOLUTION/ DROPS53
66758-095-75Travatan Z1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-095-56ML - Milliliter66758-09527eea4c0-37e8-45c8-9125-6e556679343612024-10-04
66758-095-75ML - Milliliter66758-095f3f523a4-6888-49db-a637-21166d4b4f0412024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-095TRAVATAN Z (TRAVOPROST) SOLUTION/ DROPS [SANDOZ INC]3Current NDC, 4 package rows20250312_4b5cffb0-74e0-44e4-8e18-f5d56e9db450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
285032TRAVATAN Z 0.004 % Ophthalmic SolutionPSN4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
284008travoprost 0.004 % Ophthalmic SolutionPSN4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
285032travoprost 0.04 MG/ML Ophthalmic Solution [Travatan]SBD4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
285032Travatan 0.004 % Ophthalmic SolutionSY4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
285032Travatan 0.04 MG/ML Ophthalmic SolutionSY4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
285032Travatan Z 0.004 % Ophthalmic SolutionSY4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
284008travoprost 0.004 % Ophthalmic SolutionSY4b5cffb0-74e0-44e4-8e18-f5d56e9db4503
284008travoprost 40 MCG/ML Ophthalmic SolutionSY4b5cffb0-74e0-44e4-8e18-f5d56e9db4503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-095-56667580095561 BOTTLE in 1 CARTON (66758-095-56) / 2.5 mL in 1 BOTTLE1 bottle2024-09-02NoNoHistorical
66758-095-75667580095751 BOTTLE in 1 CARTON (66758-095-75) / 5 mL in 1 BOTTLE1 bottle2024-09-02NoNoHistorical