Olopatadine Hydrochloride

Product NDC: 61314-272
11-digit product format: 613140272
Labeler code: 61314
Product ID: 61314-272_87463617-ff29-4f2b-9b8c-72c36bb099ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olopatadine Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA021545
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2007-02-15
Marketing end: 2022-09-30
Substance: OLOPATADINE HYDROCHLORIDE
Active strength: 2 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: 0000-00-00
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	61314-272		D	Discontinued by firm		2026-08-17
excluded package	package	61314-272	61314-272-25	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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61314-272-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61314-272-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61314-272-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61314-272-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61314-272-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61314-272-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61314-272-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61314-272-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61314-272-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61314-272-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61314-272-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61314-272-25	`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
N021545-001	PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	PATADAY	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	2004-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021545-001	PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2004-12-22	`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	N021545-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021545-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	AT	1	`ea99ee380514…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021545-001	7402609	2022-06-19		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	6995186	2023-11-12	U-765	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021545-001	7402609	2022-06-19		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	6995186	2023-11-12	U-765	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021545-001	7402609	2022-06-19		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	6995186	2023-11-12	U-765	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021545-001	7402609	2022-06-19		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	7402609*PED	2022-12-19		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	6995186	2023-11-12	U-765	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021545-001	6995186*PED	2024-05-12		Pediatric extension	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-272-25	ML - Milliliter	61314-272	43aa9b11-0383-4f1e-aebc-31e7b5774c54	1	2017-07-07

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	1c7d2342-ba1c-4244-9814-d92a05725d4e	2026-01-20	Warnings	Exact identifier application applno (NDA): 021545 application number: NDA021545

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
61314-272-25	61314027225	1 BOTTLE, DROPPER in 1 CARTON (61314-272-25) > 2.5 mL in 1 BOTTLE, DROPPER	2017-06-09	2022-09-30	No	No	Current