Olopatadine Hydrochloride

Product NDC: 69097-600
11-digit product format: 690970600
Labeler code: 69097
Product ID: 69097-600_8ab00345-d0c7-4f29-9990-b23c67657888
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Cipla USA Inc.
Application: ANDA206087
Marketing category: ANDA
Marketing start: 2021-03-19
Marketing end: 0000-00-00
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 2 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69097-600		D	Discontinued by firm		2026-08-17
excluded package	package	69097-600	69097-600-33	D	Discontinued by firm		2026-08-17

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
A206087-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-12-05

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	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-12-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206087-001	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-12-05	`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	A206087-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A206087-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206087-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206087-001	AT	1	`ea99ee380514…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-600	OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [CIPLA USA INC.]	2	Legacy NDC	20211203_172dbf94-d618-42fe-9cb8-552e0e0625f2.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN COMPANY	26703751-00c4-451b-a5be-242da9cd2b88	2025-12-16	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
EQUATE OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WAL-MART STORES, INC.,	3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de84	2025-08-19	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	TARGET CORPORATION	355df5ce-95e2-4d05-9114-a3190d934d3a	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
LEADER OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH	71d922d2-22a5-4103-a3eb-126094ee8ef5	2025-04-14	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	9e4c86f3-e674-4727-a136-6735591ef816	2025-01-30	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Bausch & Lomb Incorporated	c420fd56-adea-4796-adaa-977b91fbf20a	2025-01-30	Warnings	Exact identifier application applno (ANDA): 206087 application number: ANDA206087

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	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-600-33	69097060033	1 BOTTLE, PLASTIC in 1 CARTON (69097-600-33) > 2.5 mL in 1 BOTTLE, PLASTIC	2021-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION	Cipla USA Inc. \| Cipla Ltd. Indore	2021-11-30	HUMAN OTC DRUG LABEL	2