FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
43598-764
11-digit product format
435980764
Labeler code
43598
Product ID
43598-764_bdf7e94a-e260-6ba4-3545-aac867c9dade
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA209752
Marketing category
ANDA
Marketing start
2020-09-01
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 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

Additional Listing Data#

Finished product
Yes
Brand name base
Olopatadine Hydrochloride Ophthalmic Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111343

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-764-02ML - Milliliter43598-7641f7edda1-b895-40f0-baf1-d7643e4f810112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-764OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [DR. REDDY'S LABORATORIES INC.]3Current NDC, Legacy NDC20231106_f249d79e-0f62-d2f1-bcbc-22dda253aad2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 0.2 % Ophthalmic SolutionSYb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN685192af-d729-3066-5825-6d0e03ce787e5
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD685192af-d729-3066-5825-6d0e03ce787e5
1111343olopatadine 0.2 % Ophthalmic SolutionSY685192af-d729-3066-5825-6d0e03ce787e5
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY685192af-d729-3066-5825-6d0e03ce787e5
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN0cb0bb66-def2-35d4-7fe0-987757095d084
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNd9a01be0-218b-b2b9-1cbf-14a9c160ceb24
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNe3153a5a-35ca-6c10-eec0-8347c2da121f4
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDd9a01be0-218b-b2b9-1cbf-14a9c160ceb24
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDe3153a5a-35ca-6c10-eec0-8347c2da121f4
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD0cb0bb66-def2-35d4-7fe0-987757095d084
1111343olopatadine 0.2 % Ophthalmic SolutionSYf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine 0.2 % Ophthalmic SolutionSYfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 0.2 % Ophthalmic SolutionSYe3153a5a-35ca-6c10-eec0-8347c2da121f4
1111343olopatadine 0.2 % Ophthalmic SolutionSYfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 0.2 % Ophthalmic SolutionSYd9a01be0-218b-b2b9-1cbf-14a9c160ceb24
1111343olopatadine 0.2 % Ophthalmic SolutionSY0cb0bb66-def2-35d4-7fe0-987757095d084
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYe3153a5a-35ca-6c10-eec0-8347c2da121f4
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY0cb0bb66-def2-35d4-7fe0-987757095d084
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYd9a01be0-218b-b2b9-1cbf-14a9c160ceb24
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYf249d79e-0f62-d2f1-bcbc-22dda253aad24
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNfa75f236-0170-e7be-ce8c-7dff7c36fac83
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNf6d70b01-941b-b796-ceee-7f24b6038e7d3
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDf6d70b01-941b-b796-ceee-7f24b6038e7d3
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDfa75f236-0170-e7be-ce8c-7dff7c36fac83
1111343olopatadine 0.2 % Ophthalmic SolutionSYf6d70b01-941b-b796-ceee-7f24b6038e7d3
1111343olopatadine 0.2 % Ophthalmic SolutionSYfa75f236-0170-e7be-ce8c-7dff7c36fac83
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYf6d70b01-941b-b796-ceee-7f24b6038e7d3
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYfa75f236-0170-e7be-ce8c-7dff7c36fac83
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN56d4b17c-bc5d-0734-32c9-bb10ec77f7b42
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e22
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e22
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD56d4b17c-bc5d-0734-32c9-bb10ec77f7b42
1111343olopatadine 0.2 % Ophthalmic SolutionSY56d4b17c-bc5d-0734-32c9-bb10ec77f7b42
1111343olopatadine 0.2 % Ophthalmic SolutionSY9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e22
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY56d4b17c-bc5d-0734-32c9-bb10ec77f7b42
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY9a9f38fc-af2c-bc7c-abe4-8ad58d51f2e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-764-02435980764021 BOTTLE, PLASTIC in 1 CARTON (43598-764-02) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent
43598-764-25435980764252 BOTTLE, PLASTIC in 1 CARTON (43598-764-25) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent