Olopatadine Hydrochloride

Product NDC: 65862-757
11-digit product format: 658620757
Labeler code: 65862
Product ID: 65862-757_66c1d070-4b23-4170-b7f3-4b0981f22e81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olopatadine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Aurobindo Pharma Limited
Application: ANDA204812
Marketing category: ANDA
Marketing start: 2015-12-18
Marketing end: 2022-05-31
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	65862-757		D	Discontinued by firm		2026-08-10
excluded package	package	65862-757	65862-757-05	D	Discontinued by firm		2026-08-10

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 · 24 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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`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	65862-757-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A204812-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-12-18

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	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204812-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204812-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204812-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204812-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204812-001	AT	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-757-05	ML - Milliliter	65862-757	749a4985-0bf7-4195-9ca6-370485d78d56	1	2016-01-13

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Sportpharm LLC	f0cc699c-545d-4097-b85d-b67ba550863c	2026-04-24	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	94b1fe3b-6a9b-475a-9c65-1700ce1c2183	2025-10-09	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce23269-9678-58be-e063-6294a90aa1d3	2024-10-22	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	f5bddc73-1899-b5f0-e053-2995a90ab98f	2024-06-14	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	f3b054d2-4abd-4a1f-910d-0c61e2a24fbf	2023-07-10	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	c4ad0d8e-7539-4dc8-825d-d5e9ff27e488	2023-02-02	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	09dda927-4191-425c-936c-1acbf94ef657	2022-09-03	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	06467360-22fe-4a48-b234-06dbff30e853	2022-06-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	637cb721-53bf-4938-80a6-5760980098eb	2021-11-11	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b631055d-c279-215f-e053-2a95a90a8c9c	2021-09-30	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bd2deb79-c135-2d3f-e053-2a95a90a9322	2021-05-07	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	f8993bc2-0fb3-4802-8187-3677d0e58026	2021-01-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	c12af544-995a-43d7-8404-94906d52fa07	2020-08-28	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	8fb16daa-340d-45a0-ab22-e028d77e2476	2020-08-21	Warnings	Exact identifier application applno (ANDA): 204812 application number: ANDA204812

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
65862-757-05	65862075705	1 BOTTLE in 1 CARTON (65862-757-05) > 5 mL in 1 BOTTLE	1 bottle	2015-12-18	2022-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% Rx Only	Aurobindo Pharma Limited	2020-12-15	Human Prescription Drug Label	3
Olapatadine Hydrochloride	Direct Rx	2019-10-23	HUMAN PRESCRIPTION DRUG LABEL	1