Home NDC 82584-609 ZIOPTAN
Product NDC 82584-609
11-digit product format 825840609
Labeler code 82584
Product ID 82584-609_50281dbf-7a22-69dc-e063-6294a90a2cb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tafluprost
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Thea Pharma Inc.
Application NDA202514
Marketing category NDA
Marketing start 2022-10-28
Substance TAFLUPROST
Active strength .015 mg/mL
Pharmacologic classes Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], 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 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 N202514-001 ZIOPTAN TAFLUPROST 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202514-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 N202514-001 9999593 2029-05-28 Drug product 2018-07-09
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 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2012-02-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202514-001 ZIOPTAN 0.0015% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 94 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 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202514-001 5886035 2022-12-18 U-778 Drug substance, Drug product 2012-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202514-001 5886035 2022-12-18 U-778 Drug substance, Drug product 2012-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202514-001 5886035 2022-12-18 U-778 Drug substance, Drug product 2012-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202514-001 10864159 2029-05-28 U-778 Drug product 2021-01-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202514-001 5886035 2022-12-18 U-778 Drug substance, Drug product 2012-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202514-001 9999593 2029-05-28 Drug product 2018-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202514-001 5886035 2022-12-18 U-778 Drug substance, Drug product 2012-02-27 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base ZIOPTAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAFLUPROST .015 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1O6WQ6T7G3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1244611 Internal RxNorm lookup 1244616 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 82584-609-01 ZIOPTAN 0.3 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.3 7 82584-609-01 ZIOPTAN 10 in 1 POUCH SOLUTION/ DROPS 10 7 82584-609-30 ZIOPTAN 3 in 1 CARTON SOLUTION/ DROPS 3 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82584-609 ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [THEA PHARMA INC.] 5 Current NDC, Legacy NDC, 3 package rows 20240430_db529b54-2ac7-4020-9791-7333bbe6c90f.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 Marketing end Sample Exclude flag Status 82584-609-01 82584060901 0.3 mL in 1 VIAL, SINGLE-USE 0.3 ml Historical 82584-609-30 82584060930 3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE 3 pouch 2022-10-28 0000-00-00 No No Current