FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
43598-765
11-digit product format
435980765
Labeler code
43598
Product ID
43598-765_da7ca47a-02e5-c613-0a7b-f054b0cdbf14
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA209619
Marketing category
ANDA
Marketing start
2020-09-01
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

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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111339

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-765-07Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54
43598-765-07Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-765-07ML - Milliliter43598-7652d0eed44-3338-4d43-b7cd-7d2837bf175012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-765OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [DR. REDDY'S LABORATORIES INC.]3Current NDC, Legacy NDC, 2 package rows20231106_cc724092-f041-6ecc-2fbf-2a29a9671c89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 0.1 % Ophthalmic SolutionSY5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY5255d142-7d04-ab80-fa97-b11c4486e42c8
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN1b5262c2-c624-1c0d-647c-20a99bea2cfa5
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD1b5262c2-c624-1c0d-647c-20a99bea2cfa5
1111339olopatadine 0.1 % Ophthalmic SolutionSY1b5262c2-c624-1c0d-647c-20a99bea2cfa5
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY1b5262c2-c624-1c0d-647c-20a99bea2cfa5
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN7ca6569a-befd-61c2-1dec-5e616051d0ce4
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNcc724092-f041-6ecc-2fbf-2a29a9671c894
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN09ef6ddb-c7b8-0f85-1eae-c97de84dc2204
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN76bee9ad-9b02-e7f5-2b55-0cd978d852974
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN02c27305-b2e8-aef3-0554-84a5db8a46954
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD7ca6569a-befd-61c2-1dec-5e616051d0ce4
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDcc724092-f041-6ecc-2fbf-2a29a9671c894
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD09ef6ddb-c7b8-0f85-1eae-c97de84dc2204
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD02c27305-b2e8-aef3-0554-84a5db8a46954
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD76bee9ad-9b02-e7f5-2b55-0cd978d852974
1111339olopatadine 0.1 % Ophthalmic SolutionSY76bee9ad-9b02-e7f5-2b55-0cd978d852974
1111339olopatadine 0.1 % Ophthalmic SolutionSY7ca6569a-befd-61c2-1dec-5e616051d0ce4
1111339olopatadine 0.1 % Ophthalmic SolutionSY09ef6ddb-c7b8-0f85-1eae-c97de84dc2204
1111339olopatadine 0.1 % Ophthalmic SolutionSYcc724092-f041-6ecc-2fbf-2a29a9671c894
1111339olopatadine 0.1 % Ophthalmic SolutionSY02c27305-b2e8-aef3-0554-84a5db8a46954
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY7ca6569a-befd-61c2-1dec-5e616051d0ce4
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYcc724092-f041-6ecc-2fbf-2a29a9671c894
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY76bee9ad-9b02-e7f5-2b55-0cd978d852974
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY09ef6ddb-c7b8-0f85-1eae-c97de84dc2204
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY02c27305-b2e8-aef3-0554-84a5db8a46954
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN5fa34b50-ffa3-4090-86f9-436f32f45cea3
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD5fa34b50-ffa3-4090-86f9-436f32f45cea3
1111339olopatadine 0.1 % Ophthalmic SolutionSY5fa34b50-ffa3-4090-86f9-436f32f45cea3
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY5fa34b50-ffa3-4090-86f9-436f32f45cea3
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNa9f03242-b5fa-5762-f9a6-b7c0c5ee46c32
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN17d185aa-3040-0779-2b11-8487b625cd392
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD17d185aa-3040-0779-2b11-8487b625cd392
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDa9f03242-b5fa-5762-f9a6-b7c0c5ee46c32
1111339olopatadine 0.1 % Ophthalmic SolutionSYa9f03242-b5fa-5762-f9a6-b7c0c5ee46c32
1111339olopatadine 0.1 % Ophthalmic SolutionSY17d185aa-3040-0779-2b11-8487b625cd392
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY17d185aa-3040-0779-2b11-8487b625cd392
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYa9f03242-b5fa-5762-f9a6-b7c0c5ee46c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-765-07435980765071 BOTTLE, PLASTIC in 1 CARTON (43598-765-07) / 5 mL in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent