FDA.reportPublic FDA data

Bimatoprost

Product NDC
60505-0583
11-digit product format
605050583
Labeler code
60505
Product ID
60505-0583_69038a16-abb9-042d-c9ac-f8727040607f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Apotex Corp.
Application
ANDA090449
Marketing category
ANDA
Marketing start
2018-10-08
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
Rxcui308739

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f71952f0-5c3a-ff37-f1fb-fed3868f6302Product name820260105
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0583-1Bimatoprost5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS57
60505-0583-1Bimatoprost1 in 1 CARTONSOLUTION/ DROPS17
60505-0583-4Bimatoprost1 in 1 CARTONSOLUTION/ DROPS17
60505-0583-4Bimatoprost2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.57
60505-0583-5Bimatoprost1 in 1 CARTONSOLUTION/ DROPS17
60505-0583-5Bimatoprost7.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS7.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0583-1ML - Milliliter60505-0583ead1c9a8-c7ab-47b0-8a45-9bd4da06887712018-10-11
60505-0583-4ML - Milliliter60505-0583f17c201e-1147-4473-8681-2cfa05f6338912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0583BIMATOPROST SOLUTION/ DROPS [APOTEX CORP.]6Current NDC, Legacy NDC, 6 package rows20240921_f5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308739bimatoprost 0.03 % Ophthalmic SolutionPSNf5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c17
308739bimatoprost 0.3 MG/ML Ophthalmic SolutionSCDf5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c17
308739bimatoprost 0.03 % Ophthalmic SolutionSYf5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0583-1605050583011 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) / 5 mL in 1 BOTTLE, DROPPER2018-10-080000-00-00NoNoCurrent
60505-0583-4605050583041 BOTTLE, DROPPER in 1 CARTON (60505-0583-4) / 2.5 mL in 1 BOTTLE, DROPPER2018-10-080000-00-00NoNoCurrent
60505-0583-5605050583051 BOTTLE, DROPPER in 1 CARTON (60505-0583-5) > 7.5 mL in 1 BOTTLE, DROPPER2018-10-080000-00-00NoNoCurrent