FDA.reportPublic FDA data

Latanoprost

Product NDC
61314-547
11-digit product format
613140547
Labeler code
61314
Product ID
61314-547_a4388e84-6b82-4d7d-915b-6997d4b44b36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA091449
Marketing category
ANDA
Marketing start
2011-01-07
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
61314-547-01Latanoprost2.5 mL in 1 BOTTLESOLUTION2.59
61314-547-01Latanoprost1 in 1 CARTONSOLUTION19
61314-547-03Latanoprost2.5 mL in 1 BOTTLESOLUTION2.59
61314-547-03Latanoprost3 in 1 CARTONSOLUTION39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-547-01ML - Milliliter61314-5476f071d6a-d9ee-4473-aeea-59a40ecb838312012-07-24
61314-547-03ML - Milliliter61314-547b9466009-83b3-4ad1-8444-033807fc92bf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LATANOPROSTACTIVE INGREDIENT6Z5B6HVF6OLATANOPROST SOLUTION [SANDOZ INC]2
LATANOPROSTACTIVE MOIETY6Z5B6HVF6OLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FLATANOPROST SOLUTION [SANDOZ INC]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNLATANOPROST SOLUTION [SANDOZ INC]2
WATERINACTIVE INGREDIENT059QF0KO0RLATANOPROST SOLUTION [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-547LATANOPROST SOLUTION [SANDOZ INC]9Current NDC, Legacy NDC, 4 package rows20241207_1fba56a6-c8dc-4f34-b05d-efdea75d2fea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.005 % Ophthalmic SolutionSY1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY1fba56a6-c8dc-4f34-b05d-efdea75d2fea9
314072latanoprost 0.005 % Ophthalmic SolutionPSN8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.005 % Ophthalmic SolutionSY8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY8fb5edec-d94a-4aad-b42e-756267a3ae552
314072latanoprost 0.005 % Ophthalmic SolutionPSN3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 0.005 % Ophthalmic SolutionSY3c47a089-2c72-f58c-e063-6294a90a4cce1
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY3c47a089-2c72-f58c-e063-6294a90a4cce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-547-01613140547011 BOTTLE in 1 CARTON (61314-547-01) / 2.5 mL in 1 BOTTLE1 bottle2011-01-070000-00-00NoNoCurrent
61314-547-03613140547033 BOTTLE in 1 CARTON (61314-547-03) / 2.5 mL in 1 BOTTLE3 bottle2011-01-070000-00-00NoNoCurrent