FDA.reportPublic FDA data

Latanoprost

Product NDC
50090-1920
11-digit product format
500901920
Labeler code
50090
Product ID
50090-1920_20c63fa7-fa12-4d09-a909-12c66ca07ef0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA201006
Marketing category
ANDA
Marketing start
2011-03-22
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
Latanoprost
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6Z5B6HVF6O
Rxcui314072

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1920-02023-02-07C16284748780-1f386c64a-3d4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LATANOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LATANOPROST OPHTHALMIC SOLUTION. LATANOPROST ophthalmic solution 0.005%, for topical ophthalmic use Initial U.S. Approval: 1996
50090-1920-02023-01-30C16284748780-1f386c64a-3d4c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LATANOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LATANOPROST OPHTHALMIC SOLUTION. LATANOPROST ophthalmic solution 0.005%, for topical ophthalmic use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1920-0Latanoprost1 in 1 CARTONSOLUTION/ DROPS111
50090-1920-0Latanoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1920-0ML - Milliliter50090-192089d5152b-8d2d-4331-abe7-349a8d70619312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1920LATANOPROST SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20250110_5f1987e0-b0ce-47b2-998b-97453a7db5c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN5f1987e0-b0ce-47b2-998b-97453a7db5c311
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD5f1987e0-b0ce-47b2-998b-97453a7db5c311
314072latanoprost 0.005 % Ophthalmic SolutionSY5f1987e0-b0ce-47b2-998b-97453a7db5c311
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY5f1987e0-b0ce-47b2-998b-97453a7db5c311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1920-0500901920001 BOTTLE in 1 CARTON (50090-1920-0) / 2.5 mL in 1 BOTTLE1 bottle2015-07-090000-00-00NoNoCurrent