FDA.reportPublic FDA data

Travoprost Ophthalmic Soluton

Product NDC
25021-002
11-digit product format
250210002
Labeler code
25021
Product ID
25021-002_591329be-fa03-4fe4-8a89-0a0f4cf5ca84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sagent Pharmaceuticals
Application
ANDA218159
Marketing category
ANDA
Marketing start
2025-07-15
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 Soluton
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
25021-002-02Travoprost Ophthalmic Soluton2.5 mL in 1 BOTTLESOLUTION/ DROPS2.51
25021-002-02Travoprost Ophthalmic Soluton1 in 1 CARTONSOLUTION/ DROPS11
25021-002-05Travoprost Ophthalmic Soluton1 in 1 CARTONSOLUTION/ DROPS11
25021-002-05Travoprost Ophthalmic Soluton5 mL in 1 BOTTLESOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-002-02ML - Milliliter25021-002f44e8c35-e399-452e-991c-76c06d436e8712025-07-08
25021-002-05ML - Milliliter25021-0023abdb4ff-dbaf-4514-904a-cf7c38b535b612025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN498a376e-a74e-48d8-a022-ad15a1ecadb51
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD498a376e-a74e-48d8-a022-ad15a1ecadb51
284008travoprost 0.004 % Ophthalmic SolutionSY498a376e-a74e-48d8-a022-ad15a1ecadb51
284008travoprost 40 MCG/ML Ophthalmic SolutionSY498a376e-a74e-48d8-a022-ad15a1ecadb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-002-02250210002021 BOTTLE in 1 CARTON (25021-002-02) / 2.5 mL in 1 BOTTLE1 bottle2025-07-15NoNoHistorical
25021-002-05250210002051 BOTTLE in 1 CARTON (25021-002-05) / 5 mL in 1 BOTTLE1 bottle2025-07-15NoNoHistorical