Bimatoprost

Product NDC
50383-912
11-digit product format
503830912
Labeler code
50383
Product ID
50383-912_390eb078-fcae-43b1-bcef-14d452cea368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Akorn
Application
ANDA203051
Marketing category
ANDA
Marketing start
2018-09-26
Marketing end
0000-00-00
Substance
BIMATOPROST
Active strength
3 ug/mL
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-912-032024-07-30C16284748780-11030e364-fba5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION. BIMATOPROST ophthalmic solution 0.03%, for topical ophthalmic use Initial U.S. Approval: 2001
50383-912-052024-07-30C16284748780-11030e364-fba5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION. BIMATOPROST ophthalmic solution 0.03%, for topical ophthalmic use Initial U.S. Approval: 2001
50383-912-032024-01-30C16284748780-11030e364-fba5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION. BIMATOPROST ophthalmic solution 0.03%, for topical ophthalmic use Initial U.S. Approval: 2001
50383-912-052024-01-30C16284748780-11030e364-fba5-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BIMATOPROST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BIMATOPROST OPHTHALMIC SOLUTION. BIMATOPROST ophthalmic solution 0.03%, for topical ophthalmic use Initial U.S. Approval: 2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-912-03ML - Milliliter50383-912f7f617da-d1d3-46de-8625-9c155ce6715b12021-03-02
50383-912-05ML - Milliliter50383-9125926fcc1-00dd-4c52-91af-0b49637714f812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-912BIMATOPROST SOLUTION [AKORN]14Legacy NDC20230107_2c997c76-fd01-479a-a005-dbdb375560a4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-912-03503830912031 BOTTLE in 1 KIT (50383-912-03) > 3 mL in 1 BOTTLE1 bottle2018-09-260000-00-00NoNoCurrent
50383-912-05503830912051 BOTTLE in 1 KIT (50383-912-05) > 5 mL in 1 BOTTLE1 bottle2021-02-150000-00-00NoNoCurrent