OLOPATADINE HYDROCHLORIDE

Product NDC
72476-852
11-digit product format
724760852
Labeler code
72476
Product ID
72476-852_3de497ac-ef3e-4eb0-88e3-723394770274
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Retail Business Services, LLC.
Application
ANDA204812
Marketing category
ANDA
Marketing start
2021-05-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OLOPATADINE HYDROCHLORIDE
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
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
72476-852-64OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12
72476-852-64OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLE, PLASTICSOLUTION52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-852OLOPATADINE HYDROCHLORIDE SOLUTION [RETAIL BUSINESS SERVICES, LLC.]2Current NDC, Legacy NDC, 2 package rows20210508_bd2deb79-c135-2d3f-e053-2a95a90a9322.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNbd2deb79-c135-2d3f-e053-2a95a90a93222
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDbd2deb79-c135-2d3f-e053-2a95a90a93222
1111339olopatadine 0.1 % Ophthalmic SolutionSYbd2deb79-c135-2d3f-e053-2a95a90a93222
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYbd2deb79-c135-2d3f-e053-2a95a90a93222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-852-64724760852641 BOTTLE, PLASTIC in 1 CARTON (72476-852-64) / 5 mL in 1 BOTTLE, PLASTIC2021-05-060000-00-00NoNoCurrent