OLOPATADINE HYDROCHLORIDE

Product NDC: 70677-1280
Requested package NDC: 70677-1280-1
11-digit product format: 706771280
Labeler code: 70677
Product ID: 70677-1280_05ab7b8d-c828-4246-b809-1eb3e4b4129f
Type: HUMAN OTC DRUG
Nonproprietary name: Olopatadine Hydrochloride ophthalmic
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Strategic Sourcing Services LLC
Application: ANDA200810
Marketing category: ANDA
Marketing start: 2025-03-01
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 1.

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
A200810-001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC			2017-06-28

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2017-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200810-001	OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	SOLUTION/DROPS / OPHTHALMIC		2017-06-28	`cb3db0bc1861…`

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	A200810-001	AT	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200810-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200810-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200810-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200810-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200810-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200810-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200810-001	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
05ab7b8d-c828-4246-b809-1eb3e4b4129f	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1	Product name	3	20210312
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
ee1438f7-d464-b7de-1b3a-aae378f7d672	Product name	8	20200121
4101b788-a943-3f81-6947-4acf7be2af4d	Product name	4	20190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3ee	Product name	1	20150323
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70677-1280-1	OLOPATADINE HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		1
70677-1280-1	OLOPATADINE HYDROCHLORIDE	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1280-1	ML - Milliliter	70677-1280	59d53fed-6357-425e-b860-2cea503c94ba	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1280	OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [STRATEGIC SOURCING SERVICES LLC]	1	Current NDC, 2 package rows	20250302_05ab7b8d-c828-4246-b809-1eb3e4b4129f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Golden State Medical Supply, Inc.	50b02d58-dd82-6d0a-e063-6294a90a28fd	2026-04-30	Warnings	Exact identifier application applno (ANDA): 200810 application number: ANDA200810
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	AmerisourceBergen Drug Corp	ea97d3d8-dc96-4c40-91e7-f076c588bf12	2026-02-16	Warnings	Exact identifier application applno (ANDA): 200810 application number: ANDA200810
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	GLENMARK THERAPEUTICS INC., USA	a80c3fd2-47b7-4ed0-b862-9c5099684607	2026-01-27	Warnings	Exact identifier application applno (ANDA): 200810 application number: ANDA200810
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE OPHTHALMIC	Strategic Sourcing Services LLC	05ab7b8d-c828-4246-b809-1eb3e4b4129f	2025-02-07	Warnings	Exact identifier application applno (ANDA): 200810 application number: ANDA200810 ndc (package): 70677-1280-1 ndc (product): 70677-1280 ndc11 (package): 70677128001

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	05ab7b8d-c828-4246-b809-1eb3e4b4129f	1
1111339	olopatadine 1 MG/ML Ophthalmic Solution	SCD	05ab7b8d-c828-4246-b809-1eb3e4b4129f	1
1111339	olopatadine 0.1 % Ophthalmic Solution	SY	05ab7b8d-c828-4246-b809-1eb3e4b4129f	1
1111339	olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution	SY	05ab7b8d-c828-4246-b809-1eb3e4b4129f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70677-1280-1	70677128001	1 BOTTLE, PLASTIC in 1 CARTON (70677-1280-1) / 5 mL in 1 BOTTLE, PLASTIC	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Strategic Sourcing Services LLC \| SamChunDang Pharm Co, Ltd	2025-02-07	HUMAN OTC DRUG LABEL	1