FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
58602-006
11-digit product format
586020006
Labeler code
58602
Product ID
58602-006_c2b06c3f-7949-4842-af5a-c39b4f251d7d
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Aurohealth LLC
Application
ANDA204812
Marketing category
ANDA
Marketing start
2020-07-15
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
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
58602-006-40OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION16
58602-006-40OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLE, PLASTICSOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-006OLOPATADINE HYDROCHLORIDE SOLUTION [AUROHEALTH LLC]5Current NDC, Legacy NDC, 2 package rows20220821_94b1fe3b-6a9b-475a-9c65-1700ce1c2183.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN94b1fe3b-6a9b-475a-9c65-1700ce1c21836
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD94b1fe3b-6a9b-475a-9c65-1700ce1c21836
1111339olopatadine 0.1 % Ophthalmic SolutionSY94b1fe3b-6a9b-475a-9c65-1700ce1c21836
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY94b1fe3b-6a9b-475a-9c65-1700ce1c21836
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNc4ad0d8e-7539-4dc8-825d-d5e9ff27e4882
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNf0cc699c-545d-4097-b85d-b67ba550863c2
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDc4ad0d8e-7539-4dc8-825d-d5e9ff27e4882
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDf0cc699c-545d-4097-b85d-b67ba550863c2
1111339olopatadine 0.1 % Ophthalmic SolutionSYc4ad0d8e-7539-4dc8-825d-d5e9ff27e4882
1111339olopatadine 0.1 % Ophthalmic SolutionSYf0cc699c-545d-4097-b85d-b67ba550863c2
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYc4ad0d8e-7539-4dc8-825d-d5e9ff27e4882
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYf0cc699c-545d-4097-b85d-b67ba550863c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58602-006-40586020006401 BOTTLE, PLASTIC in 1 CARTON (58602-006-40) / 5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent