OLOPATADINE HYDROCHLORIDE

Product NDC: 50090-5613
11-digit product format: 500905613
Labeler code: 50090
Product ID: 50090-5613_9af6a9b4-aff1-48bd-bd0c-9cdff0c1e4f2
Type: HUMAN OTC DRUG
Nonproprietary name: OLOPATADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA209995
Marketing category: ANDA
Marketing start: 2020-07-15
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: 2026-12-31
Current FDA listing: Yes

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
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 · 42 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	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…`
2022-09-29 23:25 UTC	2022-09	A209995-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2019-04-04	`e64feba35796…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: OLOPATADINE HYDROCHLORIDE
Listing expiration: 2026-12-31

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
7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	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
50090-5613-0	OLOPATADINE HYDROCHLORIDE	2.5 mL in 1 BOTTLE, PLASTIC	SOLUTION	2.5		12
50090-5613-0	OLOPATADINE HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5613-0	ML - Milliliter	50090-5613	5b2fc37b-e3d2-4c8a-a0d0-ed183840c05e	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5613	OLOPATADINE HYDROCHLORIDE SOLUTION [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 2 package rows	20230623_7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19.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	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 ndc (product): 50090-5613
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111343	olopatadine HCl 0.2 % Ophthalmic Solution	PSN	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	12
1111343	olopatadine 2 MG/ML Ophthalmic Solution	SCD	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	12
1111343	olopatadine 0.2 % Ophthalmic Solution	SY	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	12
1111343	olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic Solution	SY	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5613-0	50090561300	1 BOTTLE, PLASTIC in 1 CARTON (50090-5613-0) / 2.5 mL in 1 BOTTLE, PLASTIC	2021-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLOPATADINE HYDROCHLORIDE - A-S Medication Solutions	A-S Medication Solutions	2025-11-18	Human OTC Drug Label	12