FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
58602-007
11-digit product format
586020007
Labeler code
58602
Product ID
58602-007_aec732d7-994f-4916-974b-248f87abff2a
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Aurohealth LLC
Application
ANDA209995
Marketing category
ANDA
Marketing start
2020-07-15
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
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
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
58602-007-39OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.56
58602-007-39OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION16
58602-007-41OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.56
58602-007-41OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-007-41ML - Milliliter58602-00737cea6a8-af01-4bfc-b641-8a6c9062536012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-007OLOPATADINE HYDROCHLORIDE SOLUTION [AUROHEALTH LLC]5Current NDC, Legacy NDC, 4 package rows20220513_b022f8f9-ad3d-4a6d-96aa-24c1ccd1f422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN7c89196a-cf74-4ce3-a9fd-b3d42a9e2a1912
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD7c89196a-cf74-4ce3-a9fd-b3d42a9e2a1912
1111343olopatadine 0.2 % Ophthalmic SolutionSY7c89196a-cf74-4ce3-a9fd-b3d42a9e2a1912
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY7c89196a-cf74-4ce3-a9fd-b3d42a9e2a1912
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNb022f8f9-ad3d-4a6d-96aa-24c1ccd1f4226
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDb022f8f9-ad3d-4a6d-96aa-24c1ccd1f4226
1111343olopatadine 0.2 % Ophthalmic SolutionSYb022f8f9-ad3d-4a6d-96aa-24c1ccd1f4226
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYb022f8f9-ad3d-4a6d-96aa-24c1ccd1f4226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58602-007-39586020007391 BOTTLE, PLASTIC in 1 CARTON (58602-007-39) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent
58602-007-41586020007412 BOTTLE, PLASTIC in 1 CARTON (58602-007-41) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent