Home NDC 0781-6206 Bimatoprost
Product NDC 0781-6206
11-digit product format 007816206
Labeler code 0781
Product ID 0781-6206_68075f38-ba3d-4a73-b51a-b1b70177067d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bimatoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application ANDA202719
Marketing category ANDA
Marketing start 2016-12-06
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 A202719-001 BIMATOPROST BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202719-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202719-001 BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT 2016-04-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 1041495 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 0781-6206-75 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 22 0781-6206-75 Bimatoprost 5 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION/ DROPS 5 22 0781-6206-93 Bimatoprost 1 in 1 CARTON SOLUTION/ DROPS 1 22 0781-6206-93 Bimatoprost 3 mL in 1 BOTTLE, WITH APPLICATOR SOLUTION/ DROPS 3 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6206 BIMATOPROST SOLUTION/ DROPS [SANDOZ INC] 20 Current NDC, Legacy NDC, 4 package rows 20240511_27bef7e1-750a-4ac1-ab5f-e4c0121ffcbc.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 0781-6206-75 00781620675 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-75) / 5 mL in 1 BOTTLE, WITH APPLICATOR 2016-12-06 0000-00-00 No No Current 0781-6206-93 00781620693 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0781-6206-93) / 3 mL in 1 BOTTLE, WITH APPLICATOR 2016-12-06 0000-00-00 No No Current