Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
24208-966
11-digit product format
242080966
Labeler code
24208
Product ID
24208-966_258be954-8e76-2be4-e063-6394a90a78ca
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic Solution
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA206046
Marketing category
ANDA
Marketing start
2024-12-02
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 Ophthalmic Solution
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
24208-966-01Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION13
24208-966-01Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLESOLUTION53
24208-966-02Olopatadine Hydrochloride Ophthalmic Solution2 in 1 CARTONSOLUTION23
24208-966-02Olopatadine Hydrochloride Ophthalmic Solution5 mL in 1 BOTTLESOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-966OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION SOLUTION [BAUSCH & LOMB INCORPORATED]3Current NDC, 4 package rows20241203_468f79e0-8096-434a-a8bd-948a3d203e2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN468f79e0-8096-434a-a8bd-948a3d203e2d3
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD468f79e0-8096-434a-a8bd-948a3d203e2d3
1111339olopatadine 0.1 % Ophthalmic SolutionSY468f79e0-8096-434a-a8bd-948a3d203e2d3
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY468f79e0-8096-434a-a8bd-948a3d203e2d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24208-966-01242080966011 BOTTLE in 1 CARTON (24208-966-01) / 5 mL in 1 BOTTLE1 bottle2024-12-02NoNoHistorical
24208-966-02242080966022 BOTTLE in 1 CARTON (24208-966-02) / 5 mL in 1 BOTTLE2 bottle2024-12-02NoNoHistorical