FDA.reportPublic FDA data

Travoprost Ophthalmic

Product NDC
42571-130
11-digit product format
425710130
Labeler code
42571
Product ID
42571-130_41439a5a-db1a-ffe4-e063-6294a90a9247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost Ophthalmic Solution
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA203767
Marketing category
ANDA
Marketing start
2021-04-15
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
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
42571-130-21Travoprost Ophthalmic5 in 1 CARTONSOLUTION59
42571-130-21Travoprost Ophthalmic5 mL in 1 BOTTLESOLUTION59
42571-130-27Travoprost Ophthalmic2.5 mL in 1 BOTTLESOLUTION2.59
42571-130-27Travoprost Ophthalmic2.5 in 1 CARTONSOLUTION2.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-130-21ML - Milliliter42571-130565fa99f-acbb-44f0-8f20-7a24d67528f012021-05-05
42571-130-27ML - Milliliter42571-13000aafedf-8f59-4a69-84aa-ed90d6a04a8812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-130TRAVOPROST OPHTHALMIC (TRAVOPROST OPHTHALMIC SOLUTION) SOLUTION [MICRO LABS LIMITED]8Current NDC, Legacy NDC, 4 package rows20250112_39c8f172-9dc6-4adf-8e7f-4d1cb6940926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN2d95e26f-7cdd-462f-b32f-10cb68424aaa103
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD2d95e26f-7cdd-462f-b32f-10cb68424aaa103
284008travoprost 0.004 % Ophthalmic SolutionSY2d95e26f-7cdd-462f-b32f-10cb68424aaa103
284008travoprost 40 MCG/ML Ophthalmic SolutionSY2d95e26f-7cdd-462f-b32f-10cb68424aaa103
284008travoprost 0.004 % Ophthalmic SolutionPSNcd815d15-b559-48b3-85e0-d83f0e2f3340101
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCDcd815d15-b559-48b3-85e0-d83f0e2f3340101
284008travoprost 0.004 % Ophthalmic SolutionSYcd815d15-b559-48b3-85e0-d83f0e2f3340101
284008travoprost 40 MCG/ML Ophthalmic SolutionSYcd815d15-b559-48b3-85e0-d83f0e2f3340101
284008travoprost 0.004 % Ophthalmic SolutionPSN16d9c19c-1f8a-43c5-a2ff-78aafbf150af100
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD16d9c19c-1f8a-43c5-a2ff-78aafbf150af100
284008travoprost 0.004 % Ophthalmic SolutionSY16d9c19c-1f8a-43c5-a2ff-78aafbf150af100
284008travoprost 40 MCG/ML Ophthalmic SolutionSY16d9c19c-1f8a-43c5-a2ff-78aafbf150af100
284008travoprost 0.004 % Ophthalmic SolutionPSN39c8f172-9dc6-4adf-8e7f-4d1cb69409269
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD39c8f172-9dc6-4adf-8e7f-4d1cb69409269
284008travoprost 0.004 % Ophthalmic SolutionSY39c8f172-9dc6-4adf-8e7f-4d1cb69409269
284008travoprost 40 MCG/ML Ophthalmic SolutionSY39c8f172-9dc6-4adf-8e7f-4d1cb69409269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-130-21425710130215 BOTTLE in 1 CARTON (42571-130-21) / 5 mL in 1 BOTTLE5 bottle2021-04-150000-00-00NoNoCurrent
42571-130-27425710130272.5 BOTTLE in 1 CARTON (42571-130-27) / 2.5 mL in 1 BOTTLE2.5 bottle2021-04-150000-00-00NoNoCurrent