FDA.reportPublic FDA data

Vyzulta

Product NDC
24208-504
11-digit product format
242080504
Labeler code
24208
Product ID
24208-504_12648511-1ae2-aaf8-e063-6394a90a2297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprostene bunod
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA207795
Marketing category
NDA
Marketing start
2017-11-02
Substance
LATANOPROSTENE BUNOD
Active strength
.24 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vyzulta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROSTENE BUNOD.24 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI6393O0922
Rxcui1988394, 1988399

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d59b88b-5059-46d6-8e48-d5d9371caa10Product name220260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86Product name420250729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-504-01Vyzulta1 in 1 CARTONSOLUTION/ DROPS17
24208-504-01Vyzulta2.5 mL in 1 BOTTLESOLUTION/ DROPS2.57
24208-504-02Vyzulta1 in 1 CARTONSOLUTION/ DROPS17
24208-504-02Vyzulta2.5 mL in 1 BOTTLESOLUTION/ DROPS2.57
24208-504-05Vyzulta1 in 1 CARTONSOLUTION/ DROPS17
24208-504-05Vyzulta5 mL in 1 BOTTLESOLUTION/ DROPS57
24208-504-06Vyzulta5 mL in 1 BOTTLESOLUTION/ DROPS57
24208-504-06Vyzulta1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-504VYZULTA (LATANOPROSTENE BUNOD) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]7Current NDC, Legacy NDC, 8 package rows20240229_60ce7900-a677-4fc2-88d0-1603baa9dbd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1988394latanoprostene bunod 0.024 % Ophthalmic SolutionPSN60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988399VYZULTA 0.024 % Ophthalmic SolutionPSN60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988399latanoprostene bunod 0.24 MG/ML Ophthalmic Solution [Vyzulta]SBD60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988394latanoprostene bunod 0.24 MG/ML Ophthalmic SolutionSCD60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988394latanoprostene bunod 0.024 % Ophthalmic SolutionSY60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988399Vyzulta 0.024 % Ophthalmic SolutionSY60ce7900-a677-4fc2-88d0-1603baa9dbd47
1988399Vyzulta 0.24 MG/ML Ophthalmic SolutionSY60ce7900-a677-4fc2-88d0-1603baa9dbd47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-504-01242080504011 BOTTLE in 1 CARTON (24208-504-01) / 2.5 mL in 1 BOTTLE1 bottle2018-06-110000-00-00YesNoCurrent
24208-504-02242080504021 BOTTLE in 1 CARTON (24208-504-02) / 2.5 mL in 1 BOTTLE1 bottle2018-06-110000-00-00NoNoCurrent
24208-504-05242080504051 BOTTLE in 1 CARTON (24208-504-05) / 5 mL in 1 BOTTLE1 bottle2017-11-020000-00-00NoNoCurrent
24208-504-06242080504061 BOTTLE in 1 CARTON (24208-504-06) / 5 mL in 1 BOTTLE1 bottle2017-11-020000-00-00YesNoCurrent