EQUATE OLOPATADINE HYDROCHLORIDE

Product NDC
79903-318
11-digit product format
799030318
Labeler code
79903
Product ID
79903-318_3cbc6031-f535-ab79-e063-6294a90a0a58
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
WAL-MART STORES, INC.,
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
EQUATE 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
79903-318-01EQUATE OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION13
79903-318-01EQUATE OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53
79903-318-20EQUATE OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53
79903-318-20EQUATE OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION23
79903-318-25EQUATE OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION23
79903-318-25EQUATE OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-318EQUATE OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE) SOLUTION [WAL-MART STORES, INC.,]2Current NDC, 6 package rows20250504_3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de843
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de843
1111343olopatadine 0.2 % Ophthalmic SolutionSY3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de843
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY3ffd2bec-c5d1-47ff-ae5f-bc20e9c1de843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
79903-318-01799030318011 BOTTLE, PLASTIC in 1 CARTON (79903-318-01) / 3.5 mL in 1 BOTTLE, PLASTIC2025-04-15NoNoHistorical
79903-318-20799030318202 BOTTLE, PLASTIC in 1 CARTON (79903-318-20) / 3.5 mL in 1 BOTTLE, PLASTIC2025-04-15NoNoHistorical
79903-318-25799030318252 BOTTLE, PLASTIC in 1 CARTON (79903-318-25) / 3.5 mL in 1 BOTTLE, PLASTIC2025-08-19NoNoHistorical