FDA.reportPublic FDA data

LATISSE

Product NDC
0023-3616
11-digit product format
000233616
Labeler code
0023
Product ID
0023-3616_f3f30669-e9b1-406b-b6fc-30c520f8ffb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA022369
Marketing category
NDA
Marketing start
2009-01-26
Substance
BIMATOPROST
Active strength
.3 mg/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LATISSE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQXS94885MZ
Rxcui1041495, 1041497

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f71952f0-5c3a-ff37-f1fb-fed3868f6302Product name820260105
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3616-05LATISSE1 in 1 CARTONSOLUTION/ DROPS125
0023-3616-05LATISSE5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS525
0023-3616-70LATISSE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS325
0023-3616-70LATISSE1 in 1 CARTONSOLUTION/ DROPS125
0023-3616-71LATISSE1 in 1 CARTONSOLUTION/ DROPS125
0023-3616-71LATISSE3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS325

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3616-03ML - Milliliter0023-36160ae5b615-2f38-4ed1-a874-164d1e4ab9be12012-07-24
0023-3616-05ML - Milliliter0023-3616838bb7fc-d18a-4f91-9e80-c5af8c35f32012013-02-13
0023-3616-70ML - Milliliter0023-36166524f228-adc2-4ced-a276-d10b95d73fcb12013-10-17
0023-3616-80ML - Milliliter0023-361615b2e97e-6920-4b79-9531-8afea85a063912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bimatoprostACTIVE INGREDIENTQXS94885MZLATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
bimatoprostACTIVE MOIETYQXS94885MZLATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11
waterINACTIVE INGREDIENT059QF0KO0RLATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3616LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]24Current NDC, Legacy NDC, 6 package rows20250109_34f83d9d-2c64-463e-8a90-9a460fedfead.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041495bimatoprost 0.03 % Eyelash Topical SolutionPSN34f83d9d-2c64-463e-8a90-9a460fedfead25
1041497Latisse 0.03 % Eyelash Topical SolutionPSN34f83d9d-2c64-463e-8a90-9a460fedfead25
1041497bimatoprost 0.3 MG/ML Topical Solution [Latisse]SBD34f83d9d-2c64-463e-8a90-9a460fedfead25
1041495bimatoprost 0.3 MG/ML Topical SolutionSCD34f83d9d-2c64-463e-8a90-9a460fedfead25
1041495bimatoprost 0.03 % Eyelash Topical SolutionSY34f83d9d-2c64-463e-8a90-9a460fedfead25
1041497Latisse 0.03 % Eyelash Topical SolutionSY34f83d9d-2c64-463e-8a90-9a460fedfead25
1041497Latisse 0.3 MG/ML Topical SolutionSY34f83d9d-2c64-463e-8a90-9a460fedfead25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3616-03000233616031 BOTTLE, DROPPER in 1 CARTON (0023-3616-03) > 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-04000233616041 BOTTLE, DROPPER in 1 CARTON (0023-3616-04) > 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-05000233616051 BOTTLE, DROPPER in 1 CARTON (0023-3616-05) / 5 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-16000233616161 BOTTLE, DROPPER in 1 CARTON (0023-3616-16) > 1.5 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-70000233616701 BOTTLE, DROPPER in 1 CARTON (0023-3616-70) / 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-71000233616711 BOTTLE, DROPPER in 1 CARTON (0023-3616-71) / 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00YesNoCurrent
0023-3616-80000233616801 BOTTLE, DROPPER in 1 CARTON (0023-3616-80) > 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent
0023-3616-81000233616811 BOTTLE, DROPPER in 1 CARTON (0023-3616-81) > 3 mL in 1 BOTTLE, DROPPER2009-01-260000-00-00NoNoCurrent