FDA.reportPublic FDA data

Travoprost ophthalmic solution

Product NDC
62332-625
11-digit product format
623320625
Labeler code
62332
Product ID
62332-625_64811638-2446-4b3c-b71f-f3e8321f4230
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214687
Marketing category
ANDA
Marketing start
2025-12-17
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214687-001TRAVOPROSTTRAVOPROST0.004%SOLUTION/DROPS / OPHTHALMICAT22025-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214687-001AT2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214687-001TRAVOPROST0.004%SOLUTION/DROPS / OPHTHALMICAT22025-12-17011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214687-001TRAVOPROST0.004%SOLUTION/DROPS / OPHTHALMICAT22025-12-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214687-001AT21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214687-001AT21a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WJ68R08KX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284008Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45953a4b-5080-4959-a1e8-d1559f2e5010Available on FDA.report

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
62332-625-02Travoprost ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS18
62332-625-02Travoprost ophthalmic solution2.5 mL in 1 BOTTLESOLUTION/ DROPS2.58
62332-625-05Travoprost ophthalmic solution5 mL in 1 BOTTLESOLUTION/ DROPS58
62332-625-05Travoprost ophthalmic solution1 in 1 CARTONSOLUTION/ DROPS18

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Travoprost ophthalmic solutionTRAVOPROST OPHTHALMICAlembic Pharmaceuticals Inc.45953a4b-5080-4959-a1e8-d1559f2e50102025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214687
application number: ANDA214687
ndc (product): 62332-625
Travoprost ophthalmic solutionTRAVOPROST OPHTHALMICAlembic Pharmaceuticals Limitedda11bb76-fa62-4800-8a4e-cc76f4351e0d2025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214687
application number: ANDA214687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN45953a4b-5080-4959-a1e8-d1559f2e50108
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD45953a4b-5080-4959-a1e8-d1559f2e50108
284008travoprost 0.004 % Ophthalmic SolutionSY45953a4b-5080-4959-a1e8-d1559f2e50108
284008travoprost 40 MCG/ML Ophthalmic SolutionSY45953a4b-5080-4959-a1e8-d1559f2e50108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-625-02623320625021 BOTTLE in 1 CARTON (62332-625-02) / 2.5 mL in 1 BOTTLE1 bottle2025-12-17NoNoCurrent
62332-625-05623320625051 BOTTLE in 1 CARTON (62332-625-05) / 5 mL in 1 BOTTLE1 bottle2025-12-17NoNoCurrent