Olopatadine hydrochloride

Product NDC: 60505-6221
11-digit product format: 605056221
Labeler code: 60505
Product ID: 60505-6221_ac44fb6f-d383-37f2-9416-6d249604140e
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Apotex Corp.
Application: ANDA078350
Marketing category: ANDA
Marketing start: 2022-10-06
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: 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
A078350-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2015-12-07

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	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2015-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078350-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2015-12-07	`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	A078350-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078350-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078350-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078350-001	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	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
cc178825-1a4e-6bca-a00d-aa28d5abe589	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	Strength	SPL version
60505-6221-0	Olopatadine hydrochloride	5 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	5		4
60505-6221-0	Olopatadine hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6221	OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.]	3	Current NDC, Legacy NDC, 2 package rows	20240929_cc178825-1a4e-6bca-a00d-aa28d5abe589.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ec0c8c56-68d2-e63e-e053-2995a90a8db2	2025-11-24	Warnings	Exact identifier application applno (ANDA): 078350 application number: ANDA078350
Olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Apotex Corp.	cc178825-1a4e-6bca-a00d-aa28d5abe589	2025-09-19	Warnings	Exact identifier application applno (ANDA): 078350 application number: ANDA078350 ndc (product): 60505-6221
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Allegiant Health	fdb808ef-9d5f-4bc3-86e7-f519b5c75a46	2025-05-05	Warnings	Exact identifier application applno (ANDA): 078350 application number: ANDA078350

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	cc178825-1a4e-6bca-a00d-aa28d5abe589	4
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	cc178825-1a4e-6bca-a00d-aa28d5abe589	4
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	cc178825-1a4e-6bca-a00d-aa28d5abe589	4
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	cc178825-1a4e-6bca-a00d-aa28d5abe589	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-6221-0	60505622100	1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0) / 5 mL in 1 BOTTLE, PLASTIC	2022-10-06	0000-00-00	No	No	Current