Home NDC 46708-511 bimatoprost
Product NDC 46708-511
11-digit product format 467080511
Labeler code 46708
Product ID 46708-511_2b4107e4-c108-4ed5-b7e8-253b74f2ff25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bimatoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Limited
Application ANDA210515
Marketing category ANDA
Marketing start 2023-07-21
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210515-001 BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210515-001 AT
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210515-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2020-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base bimatoprost
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BIMATOPROST .3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QXS94885MZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308739 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-511-03 bimatoprost 3 mL in 1 BOTTLE SOLUTION/ DROPS 3 1 46708-511-03 bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 1 46708-511-05 bimatoprost 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 1 46708-511-05 bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-511 BIMATOPROST SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20230722_2b4107e4-c108-4ed5-b7e8-253b74f2ff25.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-511-03 46708051103 1 BOTTLE in 1 CARTON (46708-511-03) / 3 mL in 1 BOTTLE 1 bottle 2023-07-21 No No Current 46708-511-05 46708051105 1 BOTTLE in 1 CARTON (46708-511-05) / 5 mL in 1 BOTTLE 1 bottle 2023-07-21 No No Current