FDA.reportPublic FDA data

Travoprost

Product NDC
60505-0593
11-digit product format
605050593
Labeler code
60505
Product ID
60505-0593_3f7a0323-bf68-c2b4-1f31-11df63e41dec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
travoprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA203431
Marketing category
ANDA
Marketing start
2019-12-18
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
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
60505-0593-1Travoprost5 mL in 1 BOTTLESOLUTION512
60505-0593-1Travoprost1 in 1 CARTONSOLUTION112
60505-0593-4Travoprost2.5 mL in 1 BOTTLESOLUTION2.512
60505-0593-4Travoprost1 in 1 CARTONSOLUTION112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0593-1ML - Milliliter60505-05935a28c765-85c8-457a-8852-b2633572803d12020-01-03
60505-0593-4ML - Milliliter60505-0593d57d72c4-452b-4ea7-aa0e-569472837d4b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0593TRAVOPROST SOLUTION [APOTEX CORP.]10Current NDC, Legacy NDC, 4 package rows20241004_98fb77b8-ee41-e2fc-7bcd-bc350e19cc10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN98fb77b8-ee41-e2fc-7bcd-bc350e19cc1012
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD98fb77b8-ee41-e2fc-7bcd-bc350e19cc1012
284008travoprost 0.004 % Ophthalmic SolutionSY98fb77b8-ee41-e2fc-7bcd-bc350e19cc1012
284008travoprost 40 MCG/ML Ophthalmic SolutionSY98fb77b8-ee41-e2fc-7bcd-bc350e19cc1012
284008travoprost 0.004 % Ophthalmic SolutionPSNefe2861a-f7ca-ae06-e053-2995a90a50e97
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCDefe2861a-f7ca-ae06-e053-2995a90a50e97
284008travoprost 0.004 % Ophthalmic SolutionSYefe2861a-f7ca-ae06-e053-2995a90a50e97
284008travoprost 40 MCG/ML Ophthalmic SolutionSYefe2861a-f7ca-ae06-e053-2995a90a50e97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0593-1605050593011 BOTTLE in 1 CARTON (60505-0593-1) / 5 mL in 1 BOTTLE1 bottle2019-12-180000-00-00NoNoCurrent
60505-0593-4605050593041 BOTTLE in 1 CARTON (60505-0593-4) / 2.5 mL in 1 BOTTLE1 bottle2019-12-180000-00-00NoNoCurrent