bimatoprost

Product NDC
62332-511
11-digit product format
623320511
Labeler code
62332
Product ID
62332-511_1da93b09-d4d2-4a87-96f5-727004afef8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimatoprost
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210515
Marketing category
ANDA
Marketing start
2020-01-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210515-001BIMATOPROSTBIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A210515-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210515-001BIMATOPROST0.03%SOLUTION/DROPS / TOPICALAT2020-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210515-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210515-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210515-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210515-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210515-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210515-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210515-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210515-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210515-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210515-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210515-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210515-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210515-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210515-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210515-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210515-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210515-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210515-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210515-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210515-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A210515-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210515-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210515-001AT1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210515-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210515-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210515-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210515-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210515-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210515-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210515-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210515-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210515-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210515-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210515-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210515-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210515-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210515-001AT1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QXS94885MZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1041495Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dfb6eabf-d8e0-4fd3-8ef6-c646da7a987dAvailable on FDA.report

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
62332-511-03bimatoprost3 mL in 1 BOTTLESOLUTION/ DROPS315
62332-511-03bimatoprost1 in 1 CARTONSOLUTION/ DROPS115
62332-511-05bimatoprost5 mL in 1 BOTTLESOLUTION/ DROPS515
62332-511-05bimatoprost1 in 1 CARTONSOLUTION/ DROPS115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-511-03ML - Milliliter62332-5114f8ed842-5e36-481e-9e72-1a813c732dbe12021-01-08
62332-511-05ML - Milliliter62332-511867e7e17-19f8-4c93-9c9a-412c8d9a7a2b12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-511BIMATOPROST SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]14Current NDC, Legacy NDC, 4 package rows20230720_dfb6eabf-d8e0-4fd3-8ef6-c646da7a987d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bimatoprostBIMATOPROSTAlembic Pharmaceuticals Inc.dfb6eabf-d8e0-4fd3-8ef6-c646da7a987d2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210515
application number: ANDA210515
ndc (product): 62332-511
bimatoprostBIMATOPROSTAlembic Pharmaceuticals Limited2b4107e4-c108-4ed5-b7e8-253b74f2ff252023-07-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210515
application number: ANDA210515

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041495bimatoprost 0.03 % Eyelash Topical SolutionPSNdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15
1041495bimatoprost 0.3 MG/ML Topical SolutionSCDdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15
1041495bimatoprost 0.03 % Eyelash Topical SolutionSYdfb6eabf-d8e0-4fd3-8ef6-c646da7a987d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-511-03623320511031 BOTTLE in 1 CARTON (62332-511-03) / 3 mL in 1 BOTTLE1 bottle2020-03-200000-00-00NoNoCurrent
62332-511-05623320511051 BOTTLE in 1 CARTON (62332-511-05) / 5 mL in 1 BOTTLE1 bottle2020-01-210000-00-00NoNoCurrent