FDA.reportPublic FDA data

Latanoprost

Product NDC
24208-463
11-digit product format
242080463
Labeler code
24208
Product ID
24208-463_41d52f40-88d7-8f69-e063-6394a90ab025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
203382e3-d801-4f70-866f-ebe316583560Product name120190624
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-463-25Latanoprost1 in 1 CARTONSOLUTION/ DROPS119
24208-463-25Latanoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-463-25ML - Milliliter24208-46384691271-55ac-418f-98c8-88c1f7039b7812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LATANOPROSTACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
LATANOPROSTACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
WATERINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6
LATANOPROSTACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
LATANOPROSTACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
LATANOPROSTACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
LATANOPROSTACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-463LATANOPROST SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]18Current NDC, Legacy NDC, 2 package rows20240113_68aaacbe-98c5-450b-9bf4-4809d7ad2ca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN68aaacbe-98c5-450b-9bf4-4809d7ad2ca019
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD68aaacbe-98c5-450b-9bf4-4809d7ad2ca019
314072latanoprost 0.005 % Ophthalmic SolutionSY68aaacbe-98c5-450b-9bf4-4809d7ad2ca019
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY68aaacbe-98c5-450b-9bf4-4809d7ad2ca019
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
314072latanoprost 0.005 % Ophthalmic SolutionPSNbfd773ed-c461-4732-b1ba-0c240f3fdae06
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCDbfd773ed-c461-4732-b1ba-0c240f3fdae06
314072latanoprost 0.005 % Ophthalmic SolutionSYbfd773ed-c461-4732-b1ba-0c240f3fdae06
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSYbfd773ed-c461-4732-b1ba-0c240f3fdae06
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
314072latanoprost 0.005 % Ophthalmic SolutionPSN7c3ba2a5-54c9-e76b-e053-2a91aa0a891f3
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD7c3ba2a5-54c9-e76b-e053-2a91aa0a891f3
314072latanoprost 0.005 % Ophthalmic SolutionSY7c3ba2a5-54c9-e76b-e053-2a91aa0a891f3
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY7c3ba2a5-54c9-e76b-e053-2a91aa0a891f3
314072latanoprost 0.005 % Ophthalmic SolutionPSN49555d0c-3631-4324-9800-be8205fdedc31
314072latanoprost 0.005 % Ophthalmic SolutionPSN213a0003-da2b-4b91-9281-c05a73f94e461
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD49555d0c-3631-4324-9800-be8205fdedc31
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD213a0003-da2b-4b91-9281-c05a73f94e461
314072latanoprost 0.005 % Ophthalmic SolutionSY213a0003-da2b-4b91-9281-c05a73f94e461
314072latanoprost 0.005 % Ophthalmic SolutionSY49555d0c-3631-4324-9800-be8205fdedc31
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY213a0003-da2b-4b91-9281-c05a73f94e461
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY49555d0c-3631-4324-9800-be8205fdedc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-463-25242080463251 BOTTLE in 1 CARTON (24208-463-25) / 2.5 mL in 1 BOTTLE1 bottle2011-03-220000-00-00NoNoCurrent