FDA.reportPublic FDA data

Bimatoprost

Product NDC
60219-2149
11-digit product format
602192149
Labeler code
60219
Product ID
60219-2149_34ba1345-2347-448c-8c94-b8b93404ade6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217289
Marketing category
ANDA
Marketing start
2025-09-22
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
Bimatoprost
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMATOPROST.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQXS94885MZ
Rxcui1009339

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
60219-2149-1Bimatoprost2.5 mL in 1 BOTTLESOLUTION/ DROPS2.54
60219-2149-1Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14
60219-2149-2Bimatoprost7.5 mL in 1 BOTTLESOLUTION/ DROPS7.54
60219-2149-2Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14
60219-2149-4Bimatoprost5 mL in 1 BOTTLESOLUTION/ DROPS54
60219-2149-4Bimatoprost1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2149-1ML - Milliliter60219-2149044c816b-8a94-4d40-9f07-116532cdfc0f12026-04-20
60219-2149-2ML - Milliliter60219-2149a115007b-c038-4572-a7a9-f57f8546240e12026-04-20
60219-2149-4ML - Milliliter60219-21491afbd3a2-4446-4014-8d9e-0fbcdb85e5ff12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009339bimatoprost 0.01 % Ophthalmic SolutionPSNea563519-3eae-4ac7-8234-173b0bd9a4f64
1009339bimatoprost 0.1 MG/ML Ophthalmic SolutionSCDea563519-3eae-4ac7-8234-173b0bd9a4f64
1009339bimatoprost 0.01 % Ophthalmic SolutionSYea563519-3eae-4ac7-8234-173b0bd9a4f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-2149-1602192149011 BOTTLE in 1 CARTON (60219-2149-1) / 2.5 mL in 1 BOTTLE1 bottle2025-09-22NoNoHistorical
60219-2149-2602192149021 BOTTLE in 1 CARTON (60219-2149-2) / 7.5 mL in 1 BOTTLE1 bottle2025-09-22NoNoHistorical
60219-2149-4602192149041 BOTTLE in 1 CARTON (60219-2149-4) / 5 mL in 1 BOTTLE1 bottle2025-09-22NoNoHistorical