FDA.reportPublic FDA data

bimatoprost

Product NDC
62332-511
11-digit product format
623320511
Labeler code
62332
Product ID
62332-511_1da93b09-d4d2-4a87-96f5-727004afef8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210515
Marketing category
ANDA
Marketing start
2020-01-21
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
bimatoprost
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQXS94885MZ
Rxcui1041495

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
62332-511-03bimatoprost3 mL in 1 BOTTLESOLUTION/ DROPS315
62332-511-03bimatoprost1 in 1 CARTONSOLUTION/ DROPS115
62332-511-05bimatoprost5 mL in 1 BOTTLESOLUTION/ DROPS515
62332-511-05bimatoprost1 in 1 CARTONSOLUTION/ DROPS115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-511-03ML - Milliliter62332-5114f8ed842-5e36-481e-9e72-1a813c732dbe12021-01-08
62332-511-05ML - Milliliter62332-511867e7e17-19f8-4c93-9c9a-412c8d9a7a2b12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-511BIMATOPROST SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 4 package rows20230720_dfb6eabf-d8e0-4fd3-8ef6-c646da7a987d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041495bimatoprost 0.03 % Eyelash Topical SolutionPSNdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15
1041495bimatoprost 0.3 MG/ML Topical SolutionSCDdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15
1041495bimatoprost 0.03 % Eyelash Topical SolutionSYdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-511-03623320511031 BOTTLE in 1 CARTON (62332-511-03) / 3 mL in 1 BOTTLE1 bottle2020-03-200000-00-00NoNoCurrent
62332-511-05623320511051 BOTTLE in 1 CARTON (62332-511-05) / 5 mL in 1 BOTTLE1 bottle2020-01-210000-00-00NoNoCurrent