Travoprost Ophthalmic Solution, 0.004%

Product NDC
0378-9651
11-digit product format
003789651
Labeler code
0378
Product ID
0378-9651_d78c5705-68ac-4363-b9ae-5facc60e2b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Travoprost Ophthalmic Solution, 0.004%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205050
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Travoprost Ophthalmic Solution, 0.004%
Listing expiration
2027-12-31

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0378-9651-32Travoprost Ophthalmic Solution, 0.004%2.5 mL in 1 BOTTLESOLUTION/ DROPS2.57
0378-9651-32Travoprost Ophthalmic Solution, 0.004%1 in 1 CARTONSOLUTION/ DROPS17
0378-9651-50Travoprost Ophthalmic Solution, 0.004%5 mL in 1 BOTTLESOLUTION/ DROPS57
0378-9651-50Travoprost Ophthalmic Solution, 0.004%1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9651-32ML - Milliliter0378-9651624786ca-ad57-4f0c-8c1e-9b9fc8363b7e12020-01-03
0378-9651-50ML - Milliliter0378-9651594abcdc-31d8-4ab9-93f7-7275fae0a7ae12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9651TRAVOPROST OPHTHALMIC SOLUTION, 0.004% SOLUTION/ DROPS [MYLAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 4 package rows20241116_00dc284f-fd96-423b-bb8f-b90ee13439bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284008travoprost 0.004 % Ophthalmic SolutionPSN00dc284f-fd96-423b-bb8f-b90ee13439bf7
284008travoprost 0.04 MG/ML Ophthalmic SolutionSCD00dc284f-fd96-423b-bb8f-b90ee13439bf7
284008travoprost 0.004 % Ophthalmic SolutionSY00dc284f-fd96-423b-bb8f-b90ee13439bf7
284008travoprost 40 MCG/ML Ophthalmic SolutionSY00dc284f-fd96-423b-bb8f-b90ee13439bf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9651-32003789651321 BOTTLE in 1 CARTON (0378-9651-32) / 2.5 mL in 1 BOTTLE1 bottle2019-12-180000-00-00NoNoCurrent
0378-9651-50003789651501 BOTTLE in 1 CARTON (0378-9651-50) / 5 mL in 1 BOTTLE1 bottle2019-12-180000-00-00NoNoCurrent