Olopatadine Hydrochloride Ophthalmic Solution

Product NDC: 68083-231
11-digit product format: 680830231
Labeler code: 68083
Product ID: 68083-231_4657bfb5-f22c-4739-9455-f3ca695d0e5d
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride Ophthalmic
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA209752
Marketing category: ANDA
Marketing start: 2020-05-20
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 2 mg/mL
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: 2027-12-31
Current FDA listing: Yes

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
unfinished product	product	68083-231		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	68083-231	68083-231-85	UNFINISHED	Active or certified unfinished drug listing		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 · 36 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	68083-231-85	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	68083-231-85	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	68083-231-85	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	68083-231-85	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	68083-231-85	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	68083-231-85	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	68083-231-85	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	68083-231-85	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	68083-231-85	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	68083-231-85	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	68083-231-85	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	68083-231-85	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	68083-231-85	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	68083-231-85	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	68083-231-85	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	68083-231-85	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	68083-231-85	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	68083-231-85	`4184dd79f89f…`	`545327b3e20f…`

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
A209752-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2020-05-20

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209752-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-05-20	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olopatadine Hydrochloride Ophthalmic Solution
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLOPATADINE HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2XG66W44KF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1111343	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9a4c58dc-aee6-441f-8081-608e4fd36193	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68083-231-01	Olopatadine Hydrochloride Ophthalmic Solution	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5	2
68083-231-01	Olopatadine Hydrochloride Ophthalmic Solution	1 in 1 CARTON	SOLUTION	1	2
68083-231-85	Olopatadine Hydrochloride Ophthalmic Solution	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5	2
68083-231-85	Olopatadine Hydrochloride Ophthalmic Solution	1000 in 1 CASE	SOLUTION	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-231	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [GLAND PHARMA LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20221111_70233f0d-c170-4a1b-8c07-417e2c1e4e86.zip
68083-231	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [GLAND PHARMA LIMITED]	1	Current NDC, Legacy NDC, 2 package rows	20200525_9a4c58dc-aee6-441f-8081-608e4fd36193.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Gland Pharma Limited	9a4c58dc-aee6-441f-8081-608e4fd36193	2026-04-22	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752 ndc (product): 68083-231
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	95424539-7883-2da3-8a46-3d1a19259e15	2026-02-17	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief	OLOPATADINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	135bb2de-b2c0-6f0c-6204-3acbb48dcfbd	2026-02-13	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution Once Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	DOLGENCORP, LLC	fa75f236-0170-e7be-ce8c-7dff7c36fac8	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Allergy Relief Eye Drops	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	CVS Pharmacy	9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Chain Drug Marketing Association INC	56d4b17c-bc5d-0734-32c9-bb10ec77f7b4	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	d9a01be0-218b-b2b9-1cbf-14a9c160ceb2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	H E B	0cb0bb66-def2-35d4-7fe0-987757095d08	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Target Corporation	b233bf3d-e6e6-a724-efd9-389b8e36d2f9	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Rite Aid Corporation	e3153a5a-35ca-6c10-eec0-8347c2da121f	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Albertsons Companies	685192af-d729-3066-5825-6d0e03ce787e	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Walgreens Company	fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	f249d79e-0f62-d2f1-bcbc-22dda253aad2	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
CVS Eye Allergy Itch Relief Once Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	CVS Health Corp	fd0e681a-f217-1a97-e9a7-d740816234ff	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Chain Drug Marketing Association INC	f6d70b01-941b-b796-ceee-7f24b6038e7d	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752
Eye Allergy Itch Relief Once Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Strategic Sourcing Services LLC	ad35e069-72ba-b8df-d6bd-18c0345c80ac	2025-12-12	Warnings	Exact identifier application applno (ANDA): 209752 application number: ANDA209752

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111343	olopatadine HCl 0.2 % Ophthalmic Solution	PSN	f249d79e-0f62-d2f1-bcbc-22dda253aad2	4
1111343	olopatadine 2 MG/ML Ophthalmic Solution	SCD	f249d79e-0f62-d2f1-bcbc-22dda253aad2	4
1111343	olopatadine 0.2 % Ophthalmic Solution	SY	f249d79e-0f62-d2f1-bcbc-22dda253aad2	4
1111343	olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution	SY	f249d79e-0f62-d2f1-bcbc-22dda253aad2	4
1111343	olopatadine HCl 0.2 % Ophthalmic Solution	PSN	9a4c58dc-aee6-441f-8081-608e4fd36193	2
1111343	olopatadine 2 MG/ML Ophthalmic Solution	SCD	9a4c58dc-aee6-441f-8081-608e4fd36193	2
1111343	olopatadine 0.2 % Ophthalmic Solution	SY	9a4c58dc-aee6-441f-8081-608e4fd36193	2
1111343	olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution	SY	9a4c58dc-aee6-441f-8081-608e4fd36193	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-231-01	68083023101	1 BOTTLE, PLASTIC in 1 CARTON (68083-231-01) / 2.5 mL in 1 BOTTLE, PLASTIC	2020-05-20	0000-00-00	No	No	Current
68083-231-85	68083023185	1000 BOTTLE, PLASTIC in 1 CASE (68083-231-85) / 2.5 mL in 1 BOTTLE, PLASTIC	20-AUG-20				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride Ophthalmic Solution - Gland Pharma Limited	Gland Pharma Limited	2026-04-22	Human OTC Drug Label	2
Olopatadine Hydrochloride Ophthalmic Solution - Dr. Reddy's Laboratories Inc.	Dr. Reddy's Laboratories Inc.	2025-12-12	Human OTC Drug Label	4
Olopatadine Hydrochloride Ophthalmic Solution - Gland Pharma Limited	Gland Pharma Limited	2022-11-10	Bulk Ingredient	2