Olopatadine Hydrochloride Ophthalmic Solution

Product NDC: 68083-477
Requested package NDC: 68083-477-85
11-digit product format: 680830477
Labeler code: 68083
Product ID: 68083-477_c1481a14-8fce-4e29-b393-3b514bda4ef7
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride Ophthalmic
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA209619
Marketing category: ANDA
Marketing start: 2017-02-14
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	68083-477	68083-477-85	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 · 18 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`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
A209619-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2019-08-02

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
2026-08-18 06:07:40	2026-07	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-08-02	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209619-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-08-02	`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	A209619-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209619-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209619-001	AT	1	`b00525d2431f…`

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	1 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
1111339	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
e7907389-32be-4d83-a6e6-4360842d4893	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-477-01	Olopatadine Hydrochloride Ophthalmic Solution	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5		2
68083-477-01	Olopatadine Hydrochloride Ophthalmic Solution	1 in 1 CARTON	SOLUTION/ DROPS	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-477	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [GLAND PHARMA LIMITED]	1	Current NDC, Legacy NDC, 2 package rows	20200819_e7907389-32be-4d83-a6e6-4360842d4893.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 · 11 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	e7907389-32be-4d83-a6e6-4360842d4893	2026-04-22	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619 ndc (product): 68083-477
Eye Allergy Itch and Redness Relief	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	5255d142-7d04-ab80-fa97-b11c4486e42c	2026-02-13	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Eye Allergy Itch and Redness Relief Twice Daily Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	7ca6569a-befd-61c2-1dec-5e616051d0ce	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Rite Aid Corporation	1b5262c2-c624-1c0d-647c-20a99bea2cfa	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Chain Drug Marketing Association INC	5fa34b50-ffa3-4090-86f9-436f32f45cea	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Target Corporation	02c27305-b2e8-aef3-0554-84a5db8a4695	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
CVS Eye Allergy Itch Relief Twice Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	CVS Health Corp	76bee9ad-9b02-e7f5-2b55-0cd978d85297	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Dr. Reddy's Laboratories Inc.	cc724092-f041-6ecc-2fbf-2a29a9671c89	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Eye Allergy Itch and Redness Relief	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Strategic Sourcing Services LLC	de5aedb8-8412-a7fd-3451-ca4bbfe8851e	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Walgreens Company	09ef6ddb-c7b8-0f85-1eae-c97de84dc220	2025-12-10	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution Twice Daily	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	DOLGENCORP, LLC	a9f03242-b5fa-5762-f9a6-b7c0c5ee46c3	2021-06-29	Warnings	Exact identifier application applno (ANDA): 209619 application number: ANDA209619

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
1111339	olopatadine HCl 0.1 % Ophthalmic Solution	PSN	e7907389-32be-4d83-a6e6-4360842d4893	2
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	e7907389-32be-4d83-a6e6-4360842d4893	2
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	e7907389-32be-4d83-a6e6-4360842d4893	2
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	e7907389-32be-4d83-a6e6-4360842d4893	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
68083-477-85	68083047785	1000 BOTTLE, PLASTIC in 1 CASE (68083-477-85) / 5 mL in 1 BOTTLE, PLASTIC	01-SEP-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