XALATAN

Product NDC
58151-419
11-digit product format
581510419
Labeler code
58151
Product ID
58151-419_45489b8b-2aab-4336-8552-1524493289f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Viatris Specialty LLC
Application
NDA020597
Marketing category
NDA
Marketing start
2024-10-22
Substance
LATANOPROST
Active strength
50 ug/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6Z5B6HVF6O
Rxcui314072, 542527

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d59b88b-5059-46d6-8e48-d5d9371caa10Product name220260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86Product name420250729
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
203382e3-d801-4f70-866f-ebe316583560Product name120190624
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-419-35XALATAN1 in 1 CARTONSOLUTION/ DROPS12
58151-419-35XALATAN2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-419-35ML - Milliliter58151-4195f082e7b-d0c5-44b6-b3f9-ec993488bee012024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-419XALATAN (LATANOPROST) SOLUTION/ DROPS [VIATRIS SPECIALTY LLC]2Current NDC, 2 package rows20241025_a98595b3-9f47-48e0-b18d-550a2095f264.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSNa98595b3-9f47-48e0-b18d-550a2095f2642
542527Xalatan 0.005 % Ophthalmic SolutionPSNa98595b3-9f47-48e0-b18d-550a2095f2642
542527latanoprost 0.05 MG/ML Ophthalmic Solution [Xalatan]SBDa98595b3-9f47-48e0-b18d-550a2095f2642
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCDa98595b3-9f47-48e0-b18d-550a2095f2642
314072latanoprost 0.005 % Ophthalmic SolutionSYa98595b3-9f47-48e0-b18d-550a2095f2642
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSYa98595b3-9f47-48e0-b18d-550a2095f2642
542527Xalatan 0.005 % Ophthalmic SolutionSYa98595b3-9f47-48e0-b18d-550a2095f2642
542527Xalatan 125 MCG per 2.5 ML Ophthalmic SolutionSYa98595b3-9f47-48e0-b18d-550a2095f2642
542527Xalatan 50 MCG/ML Ophthalmic SolutionSYa98595b3-9f47-48e0-b18d-550a2095f2642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-419-35581510419351 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER2024-10-22NoNoCurrent