ZIOPTAN

Product NDC: 17478-609
Requested package NDC: 17478-609-10
11-digit product format: 174780609
Labeler code: 17478
Product ID: 17478-609_d9181c54-4a33-414c-9f2c-6a372532fb22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tafluprost
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: NDA202514
Marketing category: NDA
Marketing start: 2014-11-26
Marketing end: 0000-00-00
Substance: TAFLUPROST
Active strength: 0 mg/.3mL
Pharmacologic classes: Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17478-609	17478-609-10	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202514-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202514-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202514-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202514-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202514-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202514-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202514-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202514-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202514-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202514-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202514-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202514-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202514-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202514-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202514-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202514-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202514-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202514-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202514-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202514-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202514-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202514-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202514-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202514-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202514-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202514-001	AT	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202514-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202514-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202514-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202514-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202514-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202514-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202514-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202514-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202514-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202514-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202514-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202514-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202514-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202514-001	AT	1	`a50c72e98297…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
470fcae6-c316-0386-e573-8b9b4af2f6cd	Product name	4	20250129

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-609-10	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012
17478-609-30	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012
17478-609-90	2024-01-30	C162847	48780-1	1030e365-287f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN ® . ZIOPTAN ® (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-609-01	ZIOPTAN	10 in 1 POUCH	SOLUTION/ DROPS	10	10
17478-609-01	ZIOPTAN	0.3 mL in 1 VIAL, SINGLE-USE	SOLUTION/ DROPS	0.3	10
17478-609-10	ZIOPTAN	1 in 1 CARTON	SOLUTION/ DROPS	1	10
17478-609-30	ZIOPTAN	3 in 1 CARTON	SOLUTION/ DROPS	3	10
17478-609-90	ZIOPTAN	9 in 1 CARTON	SOLUTION/ DROPS	9	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-609-01	EA - Each	17478-609	08d454dd-4bac-4f88-ae52-b1535c54ce1f	1	2015-07-20
17478-609-30	EA - Each	17478-609	90cf9725-5826-47c8-91f9-0d75126df853	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tafluprost	ACTIVE INGREDIENT	1O6WQ6T7G3	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Tafluprost	ACTIVE MOIETY	1O6WQ6T7G3	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Sodium Phosphate, Monobasic, Dihydrate	INACTIVE INGREDIENT	5QWK665956	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-609	ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [AKORN]	10	Legacy NDC, 5 package rows	20221005_a3173c26-0e19-47af-a01c-3fc06b2700d1.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIOPTAN	TAFLUPROST	Thea Pharma Inc.	db529b54-2ac7-4020-9791-7333bbe6c90f	2026-04-23	Adverse reactions	Exact identifier application applno (NDA): 202514 application number: NDA202514
Tafluprost Ophthalmic	TAFLUPROST	Prasco Laboratories	79fceaef-7d83-4f4b-8d5c-61a6c1ee6368	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202514 application number: NDA202514

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1O6WQ6T7G3	TAFLUPROST	209860-87-7	TAFLUPROST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1244611	tafluprost 0.0015 % Ophthalmic Solution	PSN	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244616	ZIOPTAN 0.0015 % Ophthalmic Solution	PSN	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244616	tafluprost 0.015 MG/ML Ophthalmic Solution [Zioptan]	SBD	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244611	tafluprost 0.015 MG/ML Ophthalmic Solution	SCD	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244611	tafluprost 0.0015 % Ophthalmic Solution	SY	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244616	Zioptan 0.0015 % Ophthalmic Solution	SY	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244616	Zioptan 0.0045 MG in 0.3 ML Ophthalmic Solution	SY	a3173c26-0e19-47af-a01c-3fc06b2700d1	10
1244616	Zioptan 0.015 MG/ML Ophthalmic Solution	SY	a3173c26-0e19-47af-a01c-3fc06b2700d1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-609-10	17478060910	1 POUCH in 1 CARTON (17478-609-10) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE	1 pouch	2017-11-26	0000-00-00	No	No	Current