FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
71205-345
Requested package NDC
71205-345-05
11-digit product format
712050345
Labeler code
71205
Product ID
71205-345_662f725b-28ea-4dc5-9a67-586eb1b323af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Proficient Rx LP
Application
ANDA206306
Marketing category
ANDA
Marketing start
2016-06-29
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 Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71205-34571205-345-05DDiscontinued by firm2026-08-07

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-34571205-345-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-34571205-345-05DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A206306-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07

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 UTC2026-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMICAT2015-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206306-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2015-12-07cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A206306-001AT174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206306-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206306-001AT15aa47cf7b7d7…
2019-12-14 00:12 UTC2019-12A206306-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206306-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206306-001AT1ea99ee380514…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-345OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [PROFICIENT RX LP]3Legacy NDC20221015_3cc3d6f2-cecd-490c-b48c-b605f262c04e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlopatadineOLOPATADINEA-S Medication Solutionsef573cb9-7829-4bcb-9e4c-b26014cd94db2026-05-08WarningsExact identifier
application applno (ANDA): 206306
application number: ANDA206306
OlopatadineOLOPATADINESomerset Therapeutics, LLC55142e80-c5db-46a5-85a5-e8a040bcc8cf2024-03-25WarningsExact identifier
application applno (ANDA): 206306
application number: ANDA206306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-345-05712050345051 BOTTLE in 1 CARTON (71205-345-05) > 5 mL in 1 BOTTLE1 bottle2019-10-010000-00-00NoNoCurrent