Bimatoprost

Product NDC
68083-296
11-digit product format
680830296
Labeler code
68083
Product ID
68083-296_512bd5c6-1e5d-4423-b06e-9fe80ff833c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA210126
Marketing category
ANDA
Marketing start
2019-02-12
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
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-296-01Bimatoprost5 mL in 1 BOTTLESOLUTION/ DROPS56
68083-296-01Bimatoprost1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-296BIMATOPROST SOLUTION/ DROPS [GLAND PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20220413_2a4b5b6b-fc47-40d2-8396-ff60511a4cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308739bimatoprost 0.03 % Ophthalmic SolutionPSN2a4b5b6b-fc47-40d2-8396-ff60511a4cd16
308739bimatoprost 0.3 MG/ML Ophthalmic SolutionSCD2a4b5b6b-fc47-40d2-8396-ff60511a4cd16
308739bimatoprost 0.03 % Ophthalmic SolutionSY2a4b5b6b-fc47-40d2-8396-ff60511a4cd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-296-01680830296011 BOTTLE in 1 CARTON (68083-296-01) / 5 mL in 1 BOTTLE1 bottle2019-02-120000-00-00NoNoCurrent