Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
82442-967
11-digit product format
824420967
Labeler code
82442
Product ID
82442-967_32c0905b-361c-1ee3-e063-6394a90a2bdd
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic Solution
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
TARGET CORPORATION
Application
ANDA206087
Marketing category
ANDA
Marketing start
2025-04-15
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 Ophthalmic Solution
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
82442-967-02Olopatadine Hydrochloride Ophthalmic Solution3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53
82442-967-02Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82442-967OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION SOLUTION [TARGET CORPORATION]3Current NDC, 2 package rows20250416_355df5ce-95e2-4d05-9114-a3190d934d3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN355df5ce-95e2-4d05-9114-a3190d934d3a3
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD355df5ce-95e2-4d05-9114-a3190d934d3a3
1111343olopatadine 0.2 % Ophthalmic SolutionSY355df5ce-95e2-4d05-9114-a3190d934d3a3
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY355df5ce-95e2-4d05-9114-a3190d934d3a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82442-967-02824420967021 BOTTLE, PLASTIC in 1 CARTON (82442-967-02) / 3.5 mL in 1 BOTTLE, PLASTIC2025-04-15NoNoHistorical