Home NDC 60505-0583-1 Bimatoprost
Product NDC 60505-0583
Requested package NDC 60505-0583-1
11-digit product format 605050583
Labeler code 60505
Product ID 60505-0583_f930f4d2-0919-6682-9632-34ddb70fa31a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bimatoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Apotex Corp.
Application ANDA090449
Marketing category ANDA
Marketing start 2018-10-08
Substance BIMATOPROST
Active strength .3 mg/mL
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090449-001 BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090449-001 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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090449-001 BIMATOPROST 0.03% SOLUTION/DROPS / OPHTHALMIC AT 2015-07-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bimatoprost
Listing expiration 2027-12-31 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 60505-0583-1 Bimatoprost 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 7 60505-0583-1 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0583-4 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0583-4 Bimatoprost 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 7 60505-0583-5 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0583-5 Bimatoprost 7.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 7.5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0583 BIMATOPROST SOLUTION/ DROPS [APOTEX CORP.] 6 Current NDC, Legacy NDC, 6 package rows 20240921_f5c1c8c6-2a7f-482b-6ecf-9cabd3a6a5c1.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-0583-1 60505058301 1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) / 5 mL in 1 BOTTLE, DROPPER 2018-10-08 0000-00-00 No No Current