Home NDC 24208-504 Vyzulta
Product NDC 24208-504
11-digit product format 242080504
Labeler code 24208
Product ID 24208-504_12648511-1ae2-aaf8-e063-6394a90a2297
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name latanoprostene bunod
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application NDA207795
Marketing category NDA
Marketing start 2017-11-02
Substance LATANOPROSTENE BUNOD
Active strength .24 mg/mL
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 N207795-001 VYZULTA LATANOPROSTENE BUNOD 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207795-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21
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 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2017-11-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207795-001 VYZULTA 0.024% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2017-11-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207795-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207795-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N207795-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 158 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207795-001 8058467 2029-02-21 U-2144 Drug substance 2017-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 7629345 2025-01-05 U-2144 Drug product 2017-11-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 7910767 2025-01-05 U-2144 Drug substance, Drug product 2017-11-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207795-001 7273946 2025-10-03 U-2144 Drug substance, Drug product 2017-11-21 79d66fd596c7…
Additional Listing Data#
Finished product Yes
Brand name base Vyzulta
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LATANOPROSTENE BUNOD .24 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I6393O0922 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1988394 Internal RxNorm lookup 1988399 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-504 VYZULTA (LATANOPROSTENE BUNOD) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 7 Current NDC, Legacy NDC, 8 package rows 20240229_60ce7900-a677-4fc2-88d0-1603baa9dbd4.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vyzulta LATANOPROSTENE BUNOD Bausch & Lomb Incorporated 60ce7900-a677-4fc2-88d0-1603baa9dbd4 2024-02-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 207795 application number: NDA207795 ndc (product): 24208-504
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 24208-504-01 24208050401 1 BOTTLE in 1 CARTON (24208-504-01) / 2.5 mL in 1 BOTTLE 1 bottle 2018-06-11 0000-00-00 Yes No Current 24208-504-02 24208050402 1 BOTTLE in 1 CARTON (24208-504-02) / 2.5 mL in 1 BOTTLE 1 bottle 2018-06-11 0000-00-00 No No Current 24208-504-05 24208050405 1 BOTTLE in 1 CARTON (24208-504-05) / 5 mL in 1 BOTTLE 1 bottle 2017-11-02 0000-00-00 No No Current 24208-504-06 24208050406 1 BOTTLE in 1 CARTON (24208-504-06) / 5 mL in 1 BOTTLE 1 bottle 2017-11-02 0000-00-00 Yes No Current