FDA.reportPublic FDA data

LUMIGAN

Product NDC
0023-3205
11-digit product format
000233205
Labeler code
0023
Product ID
0023-3205_719ecc42-4162-497f-ad35-9e36b8eef0d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA022184
Marketing category
NDA
Marketing start
2010-09-10
Substance
BIMATOPROST
Active strength
.1 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
LUMIGAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQXS94885MZ
Rxcui1009339, 1009341

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
0023-3205-02LUMIGAN1 in 1 CARTONSOLUTION/ DROPS118
0023-3205-02LUMIGAN2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.518
0023-3205-03LUMIGAN1 in 1 CARTONSOLUTION/ DROPS118
0023-3205-03LUMIGAN2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.518
0023-3205-05LUMIGAN1 in 1 CARTONSOLUTION/ DROPS118
0023-3205-05LUMIGAN5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS518
0023-3205-08LUMIGAN7.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS7.518
0023-3205-08LUMIGAN1 in 1 CARTONSOLUTION/ DROPS118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3205-02ML - Milliliter0023-32050b673c6d-beae-401a-b474-b12986bee33512021-01-08
0023-3205-03ML - Milliliter0023-320544e07a64-de2f-4ff7-a739-187d9e6d39a812012-07-24
0023-3205-05ML - Milliliter0023-3205f2dead46-a48e-4093-ba72-8cffeb4ac46c12012-07-24
0023-3205-08ML - Milliliter0023-32055dd2bc66-74c3-4098-8ecd-2d8a7b2e9f4112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bimatoprostACTIVE INGREDIENTQXS94885MZLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
bimatoprostACTIVE MOIETYQXS94885MZLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7LUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ILUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74LUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
waterINACTIVE INGREDIENT059QF0KO0RLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC. ]8
bimatoprostACTIVE INGREDIENTQXS94885MZLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
bimatoprostACTIVE MOIETYQXS94885MZLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7LUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ILUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74LUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RLUMIGAN (BIMATOPROST) SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-3205LUMIGAN (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.]17Current NDC, Legacy NDC, 8 package rows20241114_a5e67c75-db88-4372-bb07-c8dd15c97631.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009339bimatoprost 0.01 % Ophthalmic SolutionPSNa5e67c75-db88-4372-bb07-c8dd15c9763118
1009341LUMIGAN 0.01 % Ophthalmic SolutionPSNa5e67c75-db88-4372-bb07-c8dd15c9763118
1009341bimatoprost 0.1 MG/ML Ophthalmic Solution [Lumigan]SBDa5e67c75-db88-4372-bb07-c8dd15c9763118
1009339bimatoprost 0.1 MG/ML Ophthalmic SolutionSCDa5e67c75-db88-4372-bb07-c8dd15c9763118
1009339bimatoprost 0.01 % Ophthalmic SolutionSYa5e67c75-db88-4372-bb07-c8dd15c9763118
1009341Lumigan 0.01 % Ophthalmic SolutionSYa5e67c75-db88-4372-bb07-c8dd15c9763118
1009341Lumigan 0.1 MG/ML Ophthalmic SolutionSYa5e67c75-db88-4372-bb07-c8dd15c9763118
1009339bimatoprost 0.01 % Ophthalmic SolutionPSN6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
308739bimatoprost 0.03 % Ophthalmic SolutionPSN6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009341LUMIGAN 0.01 % Ophthalmic SolutionPSN6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
285128LUMIGAN 0.03 % Ophthalmic SolutionPSN6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009341bimatoprost 0.1 MG/ML Ophthalmic Solution [Lumigan]SBD6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
285128bimatoprost 0.3 MG/ML Ophthalmic Solution [Lumigan]SBD6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009339bimatoprost 0.1 MG/ML Ophthalmic SolutionSCD6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
308739bimatoprost 0.3 MG/ML Ophthalmic SolutionSCD6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009339bimatoprost 0.01 % Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
308739bimatoprost 0.03 % Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009341Lumigan 0.01 % Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
285128Lumigan 0.03 % Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
1009341Lumigan 0.1 MG/ML Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2
285128Lumigan 0.3 MG/ML Ophthalmic SolutionSY6094c742-7cea-429d-8d21-b7cbf8bfe1bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-3205-02000233205021 BOTTLE, DROPPER in 1 CARTON (0023-3205-02) / 2.5 mL in 1 BOTTLE, DROPPER2010-09-100000-00-00NoNoCurrent
0023-3205-03000233205031 BOTTLE, DROPPER in 1 CARTON (0023-3205-03) / 2.5 mL in 1 BOTTLE, DROPPER2010-09-100000-00-00NoNoCurrent
0023-3205-05000233205051 BOTTLE, DROPPER in 1 CARTON (0023-3205-05) / 5 mL in 1 BOTTLE, DROPPER2010-09-100000-00-00NoNoCurrent
0023-3205-08000233205081 BOTTLE, DROPPER in 1 CARTON (0023-3205-08) / 7.5 mL in 1 BOTTLE, DROPPER2010-09-100000-00-00NoNoCurrent