Xalatan

Product NDC: 68258-8976
11-digit product format: 682588976
Labeler code: 68258
Product ID: 68258-8976_309e27fc-3503-4307-880c-2d9492423870
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: latanoprost
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Dispensing Solutions, Inc.
Application: NDA020597
Marketing category: NDA
Marketing start: 1995-03-20
Marketing end: 0000-00-00
Substance: LATANOPROST
Active strength: 50 ug/mL
Pharmacologic classes: Prostaglandin Analog [EPC],Prostaglandins [Chemical/Ingredient]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-8976		I	Inactivated by FDA		2026-08-17
excluded package	package	68258-8976	68258-8976-2	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-8976-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-8976-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-8976-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-8976-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-8976-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-8976-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-8976-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-8976-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-8976-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-8976-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-8976-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-8976-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-8976-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-8976-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-8976-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-8976-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-8976-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-8976-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-8976-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-8976-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-8976-2	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-8976-2	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020597-001	XALATAN	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020597-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020597-001	XALATAN	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-06-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020597-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020597-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020597-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020597-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020597-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020597-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020597-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020597-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020597-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020597-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020597-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020597-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020597-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020597-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020597-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020597-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020597-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020597-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020597-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020597-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020597-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020597-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020597-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020597-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020597-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020597-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020597-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020597-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020597-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020597-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020597-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020597-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020597-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020597-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020597-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020597-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020597-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020597-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020597-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020597-001	AT	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86	Product name	4	20250729
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
de829a7d-0b51-4e4d-a051-6a6568f15688	Product name	1	20230919
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
203382e3-d801-4f70-866f-ebe316583560	Product name	1	20190624
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e516be5e-351f-4b2e-a26b-fdff13181605	Product name	1	20181220
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-8976-2	2019-11-13	C162847	48780-1	97449f38-b80d-f6ea-e053-dbdaa90aa703	Xalatan ® latanoprost ophthalmic solution 0.005% (50 µg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8976-2	Xalatan	2.5 mL in 1 BOTTLE, DROPPER	SOLUTION	2.5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
latanoprost	ACTIVE INGREDIENT	6Z5B6HVF6O	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1
latanoprost	ACTIVE MOIETY	6Z5B6HVF6O	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1
Benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1
sodium phosphate, dibasic anhydrous	INACTIVE INGREDIENT	22ADO53M6F	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-8976	XALATAN (LATANOPROST) SOLUTION [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20111007_0f4881ec-2984-4853-bc25-5b14c3b79da7.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
Latanoprost	LATANOPROST	Mylan Pharmaceuticals Inc.	463ecfde-5acb-4983-969d-0c0021bfbf48	2024-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020597 application number: NDA020597
XALATAN	LATANOPROST	Viatris Specialty LLC	a98595b3-9f47-48e0-b18d-550a2095f264	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020597 application number: NDA020597

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6Z5B6HVF6O	LATANOPROST	130209-82-4	LATANOPROST

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314072	latanoprost 0.005 % Ophthalmic Solution	PSN	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
542527	Xalatan 0.005 % Ophthalmic Solution	PSN	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
542527	latanoprost 0.05 MG/ML Ophthalmic Solution [Xalatan]	SBD	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
314072	latanoprost 0.05 MG/ML Ophthalmic Solution	SCD	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
314072	latanoprost 0.005 % Ophthalmic Solution	SY	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
314072	latanoprost 125 MCG per 2.5 ML Ophthalmic Solution	SY	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
542527	Xalatan 0.005 % Ophthalmic Solution	SY	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
542527	Xalatan 125 MCG per 2.5 ML Ophthalmic Solution	SY	0f4881ec-2984-4853-bc25-5b14c3b79da7	1
542527	Xalatan 50 MCG/ML Ophthalmic Solution	SY	0f4881ec-2984-4853-bc25-5b14c3b79da7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68258-8976-2	68258897602	2.5 mL in 1 BOTTLE, DROPPER	2.5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Xalatan ® latanoprost ophthalmic solution 0.005% (50 µg/mL)	Dispensing Solutions, Inc.	2011-10-06	HUMAN PRESCRIPTION DRUG LABEL	1