FDA.reportPublic FDA data

Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
0363-7131
11-digit product format
003637131
Labeler code
0363
Product ID
0363-7131_bd2944d1-b99e-ec75-1678-fd06e7385727
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Walgreens Company
Application
ANDA209752
Marketing category
ANDA
Marketing start
2020-10-01
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7131-25Olopatadine Hydrochloride Ophthalmic Solution2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.54
0363-7131-25Olopatadine Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7131-25ML - Milliliter0363-7131e480a444-23b4-4310-bbfe-83b0fb0dc4d812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7131OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [WALGREENS COMPANY]3Current NDC, Legacy NDC, 2 package rows20231019_fb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 0.2 % Ophthalmic SolutionSYfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYfb2f06ee-4d50-5e4e-80c9-d2d9fbf4e6a74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-7131-25003637131251 BOTTLE, PLASTIC in 1 CARTON (0363-7131-25) / 2.5 mL in 1 BOTTLE, PLASTIC2020-10-010000-00-00NoNoCurrent