OLOPATADINE HYDROCHLORIDE

Product NDC: 73581-713
Requested package NDC: 73581-713-02
11-digit product format: 735810713
Labeler code: 73581
Product ID: 73581-713_5b26b7d7-7329-7b9a-e063-6294a90ac784
Type: HUMAN OTC DRUG
Nonproprietary name: OLOPATADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: YYBA CORP
Application: ANDA209995
Marketing category: ANDA
Marketing start: 2026-09-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209995-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2019-04-04

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 · 43 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
2026-09-14 22:38:34	2026-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`f41ea6bd6efb…`

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	A209995-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A209995-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209995-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209995-001	AT	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: OLOPATADINE HYDROCHLORIDE
Listing expiration: 2027-12-31

Active Ingredients#

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

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	OLOPATADINE HYDROCHLORIDE	Best Choice	04c7b08c-52c1-427c-8b8f-fe67444fbca4	2026-04-22	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	2025-11-18	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422	2025-10-09	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	RITE AID CORPORATION	1ce2f408-6eff-ca83-e063-6394a90a6d1a	2024-10-22	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	1932ee68-43a5-6474-e063-6294a90aacaf	2024-06-14	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Amerisource Bergen	067baa0b-5c01-4908-92de-ad79c73d2c37	2023-07-10	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Meijer	d15e4288-c315-48dc-b120-6836a4b4b8c6	2022-08-11	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	dbd28ee2-bbb5-a4b1-e053-2a95a90afff4	2022-04-08	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN CO.	da0f9110-8362-497c-a209-c33a8fa8d995	2021-11-11	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Harris Teeter	b680db29-d05b-62c3-e053-2995a90a2921	2021-10-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	34723580-dfd0-4ab7-a757-d86570261e7f	2021-09-20	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Retail Business Services, LLC.	bca27f6a-d1b1-1d6a-e053-2995a90a37b5	2021-04-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allwell Health Inc	12d48ef6-ccf1-4bc3-8469-0061bb083f7c	2021-03-01	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Kroger Company	dc80e8b0-21f7-4b12-93cb-738619f2be7c	2021-01-28	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	5f9e93e7-ff12-484d-add8-4f834193c1c6	2020-10-09	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Aurohealth LLC	aa763fdb-22a8-4975-b634-d4e6e105f588	2020-08-28	Warnings	Exact identifier application applno (ANDA): 209995 application number: ANDA209995

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	Sample	Exclude flag	Status
73581-713-02	73581071302	2 BOTTLE in 1 CARTON (73581-713-02) / 2.5 mL in 1 BOTTLE	2 bottle	2026-09-10	No	No	Current