FDA.reportPublic FDA data

Latanoprost

Product NDC
68071-4612
11-digit product format
680714612
Labeler code
68071
Product ID
68071-4612_d775143a-5ca2-9d10-e053-2995a90a7eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA201006
Marketing category
ANDA
Marketing start
2011-03-22
Marketing end
0000-00-00
Substance
LATANOPROST
Active strength
50 ug/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
68071-4612-22025-01-30C16284748780-1d6a99b39-f0c5-a426-e053-dadaa90af4c2These 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% Initial U.S. Approval: 1996
68071-4612-22022-02-07C16284748780-1d6a99b39-f0c5-a426-e053-dadaa90af4c2These 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% Initial U.S. Approval: 1996
68071-4612-22022-01-28C16284748780-1d6a99b39-f0c5-a426-e053-dadaa90af4c2These 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% Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4612-2Latanoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4612LATANOPROST SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 1 package rows20220208_78ebea72-fd01-0552-e053-2a91aa0a698b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN78ebea72-fd01-0552-e053-2a91aa0a698b4
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD78ebea72-fd01-0552-e053-2a91aa0a698b4
314072latanoprost 0.005 % Ophthalmic SolutionSY78ebea72-fd01-0552-e053-2a91aa0a698b4
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY78ebea72-fd01-0552-e053-2a91aa0a698b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4612-2680714612022.5 mL in 1 BOTTLE (68071-4612-2) 2.5 ml2018-10-230000-00-00NoNoCurrent