Olopatadine Hydrochloride

Product NDC: 50383-943
11-digit product format: 503830943
Labeler code: 50383
Product ID: 50383-943_6f46b6ea-b467-46c0-b3e3-1fb14e8cafd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olopatadine Hydrochloride Nasal
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Akorn
Application: ANDA213757
Marketing category: ANDA
Marketing start: 2020-09-29
Marketing end: 0000-00-00
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 665 ug/1
Pharmacologic classes: Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	50383-943		D	Discontinued by firm		2026-08-11
excluded package	package	50383-943	50383-943-23	D	Discontinued by firm		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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-943-23	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-943-23	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-943-23	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-943-23	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-943-23	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-943-23	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-943-23	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-943-23	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-943-23	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-943-23	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-943-23	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`

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
A213757-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL			2020-08-19

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.

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	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	2020-08-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213757-001	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED / NASAL		2020-08-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213757-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213757-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213757-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213757-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213757-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213757-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213757-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213757-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213757-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213757-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213757-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213757-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213757-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213757-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213757-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213757-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213757-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213757-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213757-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213757-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213757-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213757-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-943-23	2024-07-30	C162847	48780-1	1030e365-46cd-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OLOPATADINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for OLOPADATINE HYDROCHLORIDE NASAL SPRAY. OLOPATADINE HYDROCHLORIDE Nasal Spray, for intranasal use Initial U.S. Approval: 1996
50383-943-23	2024-01-30	C162847	48780-1	1030e365-46cd-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use OLOPATADINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for OLOPADATINE HYDROCHLORIDE NASAL SPRAY. OLOPATADINE HYDROCHLORIDE Nasal Spray, for intranasal use Initial U.S. Approval: 1996

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-943	OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE NASAL) SPRAY, METERED [AKORN]	7	Legacy NDC	20230112_f42d26f8-c583-411b-b17f-b3ca9eaba7a2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2XG66W44KF	OLOPATADINE HYDROCHLORIDE	140462-76-6	OLOPATADINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-943-23	50383094323	1 BOTTLE in 1 CARTON (50383-943-23) > 240 SPRAY, METERED in 1 BOTTLE	1 bottle	2020-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride	Akorn \| Akorn Operating Company LLC	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	7