latanoprost

Product NDC
68083-609
11-digit product format
680830609
Labeler code
68083
Product ID
68083-609_c63757a2-c757-4098-a29d-7a94104d050f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA218257
Marketing category
ANDA
Marketing start
2024-11-26
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
68083-609-01latanoprost1 in 1 CARTONSOLUTION/ DROPS15
68083-609-01latanoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-609LATANOPROST SOLUTION/ DROPS [GLAND PHARMA LIMITED]5Current NDC, 2 package rows20241205_113abcc6-6e5c-4a57-ad6a-d69508ee990e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN113abcc6-6e5c-4a57-ad6a-d69508ee990e5
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD113abcc6-6e5c-4a57-ad6a-d69508ee990e5
314072latanoprost 0.005 % Ophthalmic SolutionSY113abcc6-6e5c-4a57-ad6a-d69508ee990e5
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY113abcc6-6e5c-4a57-ad6a-d69508ee990e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-609-01680830609011 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLE1 bottle2024-11-26NoNoCurrent