FDA.reportPublic FDA data

Latanoprost

Product NDC
59762-0333
11-digit product format
597620333
Labeler code
59762
Product ID
59762-0333_a25c5b35-f731-4e01-bd83-d455d9e12779
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020597
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-11-15
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0333-2Latanoprost2.5 mL in 1 BOTTLE, DROPPERSOLUTION2.521
59762-0333-2Latanoprost1 in 1 CARTONSOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0333-1ML - Milliliter59762-0333022f2d34-8c34-4ce6-9a39-f32c14150c7612012-07-24
59762-0333-2ML - Milliliter59762-0333d25b2791-d9e6-4a92-9f9f-1adb716a650512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
latanoprostACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION [GREENSTONE LLC]10
latanoprostACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION [GREENSTONE LLC]10
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7LATANOPROST SOLUTION [GREENSTONE LLC]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION [GREENSTONE LLC]10
sodium phosphate, dibasic, anhydrousINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION [GREENSTONE LLC]10
waterINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION [GREENSTONE LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0333LATANOPROST SOLUTION [MYLAN PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20250503_463ecfde-5acb-4983-969d-0c0021bfbf48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN463ecfde-5acb-4983-969d-0c0021bfbf4821
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD463ecfde-5acb-4983-969d-0c0021bfbf4821
314072latanoprost 0.005 % Ophthalmic SolutionSY463ecfde-5acb-4983-969d-0c0021bfbf4821
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY463ecfde-5acb-4983-969d-0c0021bfbf4821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0333-2597620333021 BOTTLE, DROPPER in 1 CARTON (59762-0333-2) / 2.5 mL in 1 BOTTLE, DROPPER2010-11-150000-00-00NoNoCurrent