FDA.reportPublic FDA data

LATANOPROST

Product NDC
70069-421
11-digit product format
700690421
Labeler code
70069
Product ID
70069-421_836e9c6e-15a0-41bd-b3bb-bd864a5fd1bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LATANOPROST
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA201786
Marketing category
ANDA
Marketing start
2019-12-03
Substance
LATANOPROST
Active strength
50 ug/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LATANOPROST
Listing expiration
2027-12-31

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
70069-421-01LATANOPROST2.5 mL in 1 BOTTLESOLUTION/ DROPS2.56
70069-421-01LATANOPROST1 in 1 CARTONSOLUTION/ DROPS16
70069-421-03LATANOPROST2.5 mL in 1 BOTTLESOLUTION/ DROPS2.56
70069-421-03LATANOPROST3 in 1 CARTONSOLUTION/ DROPS36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-421-01ML - Milliliter70069-421fdf7f599-587c-4f94-a685-3ce57554d84912020-04-20
70069-421-03ML - Milliliter70069-4212e1b431c-0a87-4e27-82d8-1f57a692ebc012021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-421LATANOPROST SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]5Current NDC, Legacy NDC, 4 package rows20250112_5d0b99ad-f05a-44c7-ac61-26b5a533ea8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314072latanoprost 0.005 % Ophthalmic SolutionPSN5d0b99ad-f05a-44c7-ac61-26b5a533ea8d6
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD5d0b99ad-f05a-44c7-ac61-26b5a533ea8d6
314072latanoprost 0.005 % Ophthalmic SolutionSY5d0b99ad-f05a-44c7-ac61-26b5a533ea8d6
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY5d0b99ad-f05a-44c7-ac61-26b5a533ea8d6
314072latanoprost 0.005 % Ophthalmic SolutionPSNbe74d517-7f73-a74c-e053-2a95a90a38192
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCDbe74d517-7f73-a74c-e053-2a95a90a38192
314072latanoprost 0.005 % Ophthalmic SolutionSYbe74d517-7f73-a74c-e053-2a95a90a38192
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSYbe74d517-7f73-a74c-e053-2a95a90a38192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-421-01700690421011 BOTTLE in 1 CARTON (70069-421-01) / 2.5 mL in 1 BOTTLE1 bottle2019-12-030000-00-00NoNoCurrent
70069-421-03700690421033 BOTTLE in 1 CARTON (70069-421-03) / 2.5 mL in 1 BOTTLE3 bottle2019-12-030000-00-00NoNoCurrent