LATANOPROST

Product NDC
64980-516
11-digit product format
649800516
Labeler code
64980
Product ID
64980-516_c9d37a89-f385-4cd5-9a18-15abc5ba2dd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
latanoprost
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202442
Marketing category
ANDA
Marketing start
2016-09-01
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
64980-516-25LATANOPROST1 in 1 CARTONSOLUTION114
64980-516-25LATANOPROST2.5 mL in 1 BOTTLE, DROPPERSOLUTION2.514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-516LATANOPROST SOLUTION [RISING PHARMA HOLDINGS, INC.]14Current NDC, Legacy NDC, 2 package rows20240901_e25b82a9-1b04-4b40-8472-be107a2a6731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSNe25b82a9-1b04-4b40-8472-be107a2a673114
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCDe25b82a9-1b04-4b40-8472-be107a2a673114
314072latanoprost 0.005 % Ophthalmic SolutionSYe25b82a9-1b04-4b40-8472-be107a2a673114
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSYe25b82a9-1b04-4b40-8472-be107a2a673114
314072latanoprost 0.005 % Ophthalmic SolutionPSN88efde63-9a7e-5b29-e053-2a95a90ae4cb2
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD88efde63-9a7e-5b29-e053-2a95a90ae4cb2
314072latanoprost 0.005 % Ophthalmic SolutionSY88efde63-9a7e-5b29-e053-2a95a90ae4cb2
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY88efde63-9a7e-5b29-e053-2a95a90ae4cb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-516-25649800516251 BOTTLE, DROPPER in 1 CARTON (64980-516-25) / 2.5 mL in 1 BOTTLE, DROPPER2016-09-010000-00-00NoNoCurrent