OLOPATADINE HYDROCHLORIDE

Product NDC
72189-053
11-digit product format
721890053
Labeler code
72189
Product ID
72189-053_9595068f-5a1d-9d7e-e053-2a95a90aaf8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA204812
Marketing category
ANDA
Marketing start
2019-10-23
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
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72189-053DDiscontinued by firm2026-08-10
excluded packagepackage72189-05372189-053-05DDiscontinued by firm2026-08-10

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72189-053-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72189-053-05DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72189-053-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72189-053-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72189-053-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72189-053-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72189-053-05IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-053-05IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-053-05IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72189-053-05IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72189-053-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72189-053-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage72189-053-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage72189-053-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage72189-053-05IInactivated by FDA1332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204812-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-183f01610625f2…
2019-09-15 20:21 UTC2019-09A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204812-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204812-001AT174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A204812-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204812-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204812-001AT1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-053-052025-06-10C16284748780-1f386c649-fed9-0266-e053-dadaa90a7c1aOlapatadine Hydrochloride
72189-053-052023-01-30C16284748780-1f386c649-fed9-0266-e053-dadaa90a7c1aOlapatadine Hydrochloride

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-053-05ML - Milliliter72189-053a6b825c6-61b1-40fa-bb63-9d261554272412019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-053OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [DIRECT RX]1Legacy NDC20191123_9595068f-5a1c-9d7e-e053-2a95a90aaf8b.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDESportpharm LLCf0cc699c-545d-4097-b85d-b67ba550863c2026-04-24WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLC94b1fe3b-6a9b-475a-9c65-1700ce1c21832025-10-09WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERITE AID CORPORATION1ce23269-9678-58be-e063-6294a90aa1d32024-10-22WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDETOPCO ASSOCIATES LLCf5bddc73-1899-b5f0-e053-2995a90ab98f2024-06-14WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAmerisource Bergenf3b054d2-4abd-4a1f-910d-0c61e2a24fbf2023-07-10WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEA-S Medication Solutionsc4ad0d8e-7539-4dc8-825d-d5e9ff27e4882023-02-02WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEMeijer09dda927-4191-425c-936c-1acbf94ef6572022-09-03WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWal-Mart Stores, Inc.06467360-22fe-4a48-b234-06dbff30e8532022-06-21WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEWALGREEN CO.637cb721-53bf-4938-80a6-5760980098eb2021-11-11WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEHarris Teeterb631055d-c279-215f-e053-2a95a90a8c9c2021-09-30WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDERetail Business Services, LLC.bd2deb79-c135-2d3f-e053-2a95a90a93222021-05-07WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEKroger Companyf8993bc2-0fb3-4802-8187-3677d0e580262021-01-28WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLCc12af544-995a-43d7-8404-94906d52fa072020-08-28WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812
OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEAurohealth LLC8fb16daa-340d-45a0-ab22-e028d77e24762020-08-21WarningsExact identifier
application applno (ANDA): 204812
application number: ANDA204812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-053-05721890053051 mL in 1 BOTTLE (72189-053-05) 1 ml2019-10-230000-00-00NoNoCurrent