FDA.reportPublic FDA data

Travoprost Ophthalmic Solution

Product NDC
68462-943
11-digit product format
684620943
Labeler code
68462
Product ID
68462-943_23bf6ec3-65b0-4e62-9531-81d2cd742f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
GLENMARK PHARMACEUTICALS INC
Application
ANDA218159
Marketing category
ANDA
Marketing start
2024-09-30
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-943-03Travoprost Ophthalmic Solution2.5 mL in 1 BOTTLESOLUTION/ DROPS2.53
68462-943-03Travoprost Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13
68462-943-05Travoprost Ophthalmic Solution5 mL in 1 BOTTLESOLUTION/ DROPS53
68462-943-05Travoprost Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-943-03ML - Milliliter68462-94363ac196f-90cd-4a1e-afd3-52adf2363e6812024-12-10
68462-943-05ML - Milliliter68462-94314454093-2c06-469e-84dd-3f9573cef62512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-943TRAVOPROST OPHTHALMIC SOLUTION SOLUTION/ DROPS [GLENMARK PHARMACEUTICALS INC]2Current NDC, 4 package rows20241121_2b64a309-c7c1-4f12-9c1e-99fa8310612c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN2b64a309-c7c1-4f12-9c1e-99fa8310612c3
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD2b64a309-c7c1-4f12-9c1e-99fa8310612c3
284008travoprost 0.004 % Ophthalmic SolutionSY2b64a309-c7c1-4f12-9c1e-99fa8310612c3
284008travoprost 40 MCG/ML Ophthalmic SolutionSY2b64a309-c7c1-4f12-9c1e-99fa8310612c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-943-03684620943031 BOTTLE in 1 CARTON (68462-943-03) / 2.5 mL in 1 BOTTLE1 bottle2024-09-30NoNoCurrent
68462-943-05684620943051 BOTTLE in 1 CARTON (68462-943-05) / 5 mL in 1 BOTTLE1 bottle2024-09-30NoNoCurrent