FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
0536-1308
Requested package NDC
0536-1308-40
11-digit product format
005361308
Labeler code
0536
Product ID
0536-1308_9d39e5da-cb1e-a420-e72b-c6d297bd880f
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rugby Laboratories
Application
ANDA209619
Marketing category
ANDA
Marketing start
2021-01-05
Marketing end
2026-06-30
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
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-13080536-1308-40DDiscontinued by firm2026-07-31

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
A209619-001OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209619-001OLOPATADINE HYDROCHLORIDEEQ 0.1% BASESOLUTION/DROPS / OPHTHALMIC2019-08-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICGland Pharma Limitede7907389-32be-4d83-a6e6-4360842d48932026-04-22WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Eye Allergy Itch and Redness ReliefOLOPATADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADER5255d142-7d04-ab80-fa97-b11c4486e42c2026-02-13WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Eye Allergy Itch and Redness Relief Twice Daily ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.7ca6569a-befd-61c2-1dec-5e616051d0ce2025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICRite Aid Corporation1b5262c2-c624-1c0d-647c-20a99bea2cfa2025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICChain Drug Marketing Association INC5fa34b50-ffa3-4090-86f9-436f32f45cea2025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTIONTarget Corporation02c27305-b2e8-aef3-0554-84a5db8a46952025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
CVS Eye Allergy Itch Relief Twice DailyOLOPATADINE HYDROCHLORIDE OPHTHALMICCVS Health Corp76bee9ad-9b02-e7f5-2b55-0cd978d852972025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICDr. Reddy's Laboratories Inc.cc724092-f041-6ecc-2fbf-2a29a9671c892025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Eye Allergy Itch and Redness ReliefOLOPATADINE HYDROCHLORIDE OPHTHALMICStrategic Sourcing Services LLCde5aedb8-8412-a7fd-3451-ca4bbfe8851e2025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic SolutionOLOPATADINE HYDROCHLORIDE OPHTHALMICWalgreens Company09ef6ddb-c7b8-0f85-1eae-c97de84dc2202025-12-10WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619
Olopatadine Hydrochloride Ophthalmic Solution Twice DailyOLOPATADINE HYDROCHLORIDE OPHTHALMICDOLGENCORP, LLCa9f03242-b5fa-5762-f9a6-b7c0c5ee46c32021-06-29WarningsExact identifier
application applno (ANDA): 209619
application number: ANDA209619

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1308-40Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS16
0536-1308-40Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1308-40ML - Milliliter0536-13088c84710f-1a68-4670-a3a2-7f6dcc353cab12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1308OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [RUGBY LABORATORIES ]3Current NDC, Legacy NDC, 2 package rows20230629_d7bcba63-bfaf-240b-199e-2e42a91c19c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 0.1 % Ophthalmic SolutionSYd7bcba63-bfaf-240b-199e-2e42a91c19c96
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYd7bcba63-bfaf-240b-199e-2e42a91c19c96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1308-40005361308401 BOTTLE, PLASTIC in 1 CARTON (0536-1308-40) / 5 mL in 1 BOTTLE, PLASTIC2021-01-052026-06-30NoNoCurrent