olopatadine hydrochloride

Product NDC: 61314-271
Requested package NDC: 61314-271-05
11-digit product format: 613140271
Labeler code: 61314
Product ID: 61314-271_ad459669-1be0-42b3-90a5-d806b38199e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olopatadine hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA020688
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-09-15
Marketing end: 2022-11-30
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61314-271	61314-271-05	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
N020688-001	PATADAY TWICE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18

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	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	PATANOL	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1996-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020688-001	PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-12-18	`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	N020688-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020688-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020688-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020688-001	AT	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-271-05	ML - Milliliter	61314-271	03e8b5eb-884d-4980-a6bb-545c456ac38d	1	2016-01-13

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 TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	b7a24375-25df-4405-aa7c-34c46af51194	2026-01-20	Warnings	Exact identifier application applno (NDA): 020688 application number: NDA020688

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
61314-271-05	61314027105	1 BOTTLE, PLASTIC in 1 CARTON (61314-271-05) > 5 mL in 1 BOTTLE, PLASTIC	2015-09-15	2022-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%	Sandoz Inc	2018-04-26	HUMAN PRESCRIPTION DRUG LABEL	4