Olopatadine Hydrochloride

Product NDC: 69097-275
Requested package NDC: 69097-275-35
11-digit product format: 690970275
Labeler code: 69097
Product ID: 69097-275_61d82f87-9544-4bf8-871d-968669d470f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olopatadine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Cipla USA Inc.
Application: ANDA206046
Marketing category: ANDA
Marketing start: 2017-07-26
Marketing end: 0000-00-00
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	69097-275	69097-275-35	D	Discontinued by firm		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 · 12 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A206046-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-07-26

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	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206046-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-07-26	`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	A206046-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A206046-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206046-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206046-001	AT	1	`ea99ee380514…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	RUGBY LABORATORIES	96ad3623-f7cc-4c1c-aa65-d89077873b69	2026-02-24	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	WALGREEN COMPANY	66e76ab2-360c-4738-8424-c89c81007d83	2025-12-16	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046
Equate Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	WAL-MART STORES, INC.,	010b0c92-21ad-4e96-ac14-14683131da17	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046
Leader Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	CARDINAL HEALTH	d91a3512-b87b-4950-b41d-8d094c0e2c38	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	TARGET CORPORATION	879f9cf8-d6bb-483b-a6a7-28aba8806493	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Bausch & Lomb Incorporated	468f79e0-8096-434a-a8bd-948a3d203e2d	2024-10-28	Warnings	Exact identifier application applno (ANDA): 206046 application number: ANDA206046

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	Marketing end	Sample	Exclude flag	Status
69097-275-35	69097027535	5 mL in 1 BOTTLE, DROPPER (69097-275-35)	5 ml	2017-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1%	Cipla USA Inc. \| Cipla Limited- Indore	2020-09-08	HUMAN PRESCRIPTION DRUG LABEL	4