FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
69168-480
11-digit product format
691680480
Labeler code
69168
Product ID
69168-480_94283fa2-f59d-4cfd-9f02-e4aaf60382ca
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allegiant Health
Application
ANDA078350
Marketing category
ANDA
Marketing start
2025-05-05
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-480-02OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLESOLUTION/ DROPS52
69168-480-02OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION/ DROPS22
69168-480-65OLOPATADINE HYDROCHLORIDE5 mL in 1 BOTTLESOLUTION/ DROPS52
69168-480-65OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-480OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [ALLEGIANT HEALTH]1Current NDC, 4 package rows20250507_fdb808ef-9d5f-4bc3-86e7-f519b5c75a46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNfdb808ef-9d5f-4bc3-86e7-f519b5c75a462
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDfdb808ef-9d5f-4bc3-86e7-f519b5c75a462
1111339olopatadine 0.1 % Ophthalmic SolutionSYfdb808ef-9d5f-4bc3-86e7-f519b5c75a462
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYfdb808ef-9d5f-4bc3-86e7-f519b5c75a462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-480-02691680480022 BOTTLE in 1 CARTON (69168-480-02) / 5 mL in 1 BOTTLE2 bottle2025-07-31NoNoCurrent
69168-480-65691680480651 BOTTLE in 1 CARTON (69168-480-65) / 5 mL in 1 BOTTLE1 bottle2025-05-05NoNoCurrent