Home NDC 0023-3616 LATISSE
Product NDC 0023-3616
11-digit product format 000233616
Labeler code 0023
Product ID 0023-3616_f3f30669-e9b1-406b-b6fc-30c520f8ffb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bimatoprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA022369
Marketing category NDA
Marketing start 2009-01-26
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 N022369-001 LATISSE BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022369-001 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 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 265 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 9216183 2023-01-15 U-1487 2016-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 9226931 2023-01-15 U-1799 2016-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8038988 2023-08-25 U-1208 Drug substance, Drug product 2011-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 9216183 2023-01-15 U-1487 2016-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 9226931 2023-01-15 U-1799 2016-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8038988 2023-08-25 U-1208 Drug substance, Drug product 2011-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 4b0b4de00fa7…
Additional Listing Data#
Finished product Yes
Brand name base LATISSE
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041495 Internal RxNorm lookup 1041497 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 0023-3616-05 LATISSE 1 in 1 CARTON SOLUTION/ DROPS 1 25 0023-3616-05 LATISSE 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 25 0023-3616-70 LATISSE 3 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 3 25 0023-3616-70 LATISSE 1 in 1 CARTON SOLUTION/ DROPS 1 25 0023-3616-71 LATISSE 1 in 1 CARTON SOLUTION/ DROPS 1 25 0023-3616-71 LATISSE 3 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 3 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bimatoprost ACTIVE INGREDIENT QXS94885MZ LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 bimatoprost ACTIVE MOIETY QXS94885MZ LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 sodium chloride INACTIVE INGREDIENT 451W47IQ8X LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11 water INACTIVE INGREDIENT 059QF0KO0R LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-3616 LATISSE (BIMATOPROST) SOLUTION/ DROPS [ALLERGAN, INC.] 24 Current NDC, Legacy NDC, 6 package rows 20250109_34f83d9d-2c64-463e-8a90-9a460fedfead.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 0023-3616-03 00023361603 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-03) > 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-04 00023361604 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-04) > 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-05 00023361605 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-05) / 5 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-16 00023361616 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-16) > 1.5 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-70 00023361670 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-70) / 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-71 00023361671 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-71) / 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 Yes No Current 0023-3616-80 00023361680 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-80) > 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current 0023-3616-81 00023361681 1 BOTTLE, DROPPER in 1 CARTON (0023-3616-81) > 3 mL in 1 BOTTLE, DROPPER 2009-01-26 0000-00-00 No No Current