LATANOPROST

Product NDC: 68071-4893
Requested package NDC: 68071-4893-2
11-digit product format: 680714893
Labeler code: 68071
Product ID: 68071-4893_ba0d3ef4-e6d5-85a1-e053-2995a90ad555
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: latanoprost
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202442
Marketing category: ANDA
Marketing start: 2016-09-01
Marketing end: 0000-00-00
Substance: LATANOPROST
Active strength: 50 ug/mL
Pharmacologic classes: Prostaglandin Analog [EPC],Prostaglandins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	68071-4893	68071-4893-2	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
A202442-001	LATANOPROST	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT		2016-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202442-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202442-001	LATANOPROST	0.005%	SOLUTION/DROPS / OPHTHALMIC	AT	2016-04-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202442-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202442-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202442-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202442-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202442-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202442-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202442-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202442-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202442-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202442-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202442-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202442-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202442-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202442-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202442-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202442-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202442-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202442-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202442-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202442-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202442-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202442-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202442-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202442-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202442-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202442-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202442-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202442-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202442-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202442-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202442-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202442-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202442-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202442-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202442-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202442-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202442-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202442-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202442-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202442-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86	Product name	4	20250729
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
de829a7d-0b51-4e4d-a051-6a6568f15688	Product name	1	20230919
203382e3-d801-4f70-866f-ebe316583560	Product name	1	20190624
e516be5e-351f-4b2e-a26b-fdff13181605	Product name	1	20181220
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4893-2	2023-01-30	C162847	48780-1	f386c649-f8ea-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Latanoprost Ophthalmic Solution safely and effectively. See full prescribing information for Latanoprost Ophthalmic Solution. Latanoprost Ophthalmic Solution 0.005% Initial U.S. Approval:1996.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4893-2	LATANOPROST	2.5 mL in 1 BOX	SOLUTION	2.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4893	LATANOPROST SOLUTION [NUCARE PHARMACEUTICALS,INC.]	2	Legacy NDC, 1 package rows	20210130_88efde63-9a7e-5b29-e053-2a95a90ae4cb.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
LATANOPROST	LATANOPROST	Rising Pharma Holdings, Inc.	e25b82a9-1b04-4b40-8472-be107a2a6731	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202442 application number: ANDA202442

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	88efde63-9a7e-5b29-e053-2a95a90ae4cb	2
314072	latanoprost 0.05 MG/ML Ophthalmic Solution	SCD	88efde63-9a7e-5b29-e053-2a95a90ae4cb	2
314072	latanoprost 0.005 % Ophthalmic Solution	SY	88efde63-9a7e-5b29-e053-2a95a90ae4cb	2
314072	latanoprost 125 MCG per 2.5 ML Ophthalmic Solution	SY	88efde63-9a7e-5b29-e053-2a95a90ae4cb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4893-2	68071489302	2.5 mL in 1 BOX (68071-4893-2)	2.5 ml	2019-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LATANOPROST - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-01-29	HUMAN PRESCRIPTION DRUG LABEL	2