FDA.reportPublic FDA data

BIMATOPROST

Product NDC
42571-128
11-digit product format
425710128
Labeler code
42571
Product ID
42571-128_22ffbe26-763a-a793-e063-6394a90a6027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BIMATOPROST
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA202505
Marketing category
ANDA
Marketing start
2021-03-15
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
546f403c-5466-48b9-a79e-80b68d2b77d8Product name120200706
3471d048-4165-432e-a2dc-905eb43247dbProduct name420200611
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-128-21BIMATOPROST5 mL in 1 BOTTLESOLUTION/ DROPS59
42571-128-21BIMATOPROST1 in 1 CARTONSOLUTION/ DROPS19
42571-128-28BIMATOPROST1 in 1 CARTONSOLUTION/ DROPS19
42571-128-28BIMATOPROST7.5 mL in 1 BOTTLESOLUTION/ DROPS7.59
42571-128-35BIMATOPROST1 in 1 CARTONSOLUTION/ DROPS19
42571-128-35BIMATOPROST2.5 mL in 1 BOTTLESOLUTION/ DROPS2.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-128-21ML - Milliliter42571-12829d59451-6292-4f8d-9272-4cb819f10fe012024-02-14
42571-128-28ML - Milliliter42571-12850ee4be2-e77e-4cc8-bd51-cd8dce1c480312024-02-14
42571-128-35ML - Milliliter42571-12872d12817-8fb7-48d2-92d9-cc0d4c629f2212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-128BIMATOPROST (BIMATOPROST) SOLUTION/ DROPS [MICRO LABS LIMITED]9Current NDC, Legacy NDC, 6 package rows20240927_8c021e8a-2938-42a7-a17e-2f7f97256344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308739bimatoprost 0.03 % Ophthalmic SolutionPSN8c021e8a-2938-42a7-a17e-2f7f972563449
308739bimatoprost 0.3 MG/ML Ophthalmic SolutionSCD8c021e8a-2938-42a7-a17e-2f7f972563449
308739bimatoprost 0.03 % Ophthalmic SolutionSY8c021e8a-2938-42a7-a17e-2f7f972563449
308739bimatoprost 0.03 % Ophthalmic SolutionPSN19b21ff7-847c-3dc9-e063-6394a90a20cc5
308739bimatoprost 0.3 MG/ML Ophthalmic SolutionSCD19b21ff7-847c-3dc9-e063-6394a90a20cc5
308739bimatoprost 0.03 % Ophthalmic SolutionSY19b21ff7-847c-3dc9-e063-6394a90a20cc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-128-21425710128211 BOTTLE in 1 CARTON (42571-128-21) / 5 mL in 1 BOTTLE1 bottle2021-03-150000-00-00NoNoCurrent
42571-128-28425710128281 BOTTLE in 1 CARTON (42571-128-28) / 7.5 mL in 1 BOTTLE1 bottle2021-03-150000-00-00NoNoCurrent
42571-128-35425710128351 BOTTLE in 1 CARTON (42571-128-35) / 2.5 mL in 1 BOTTLE1 bottle2021-03-150000-00-00NoNoCurrent