OLOPATADINE HYDROCHLORIDE

Product NDC
79481-1001
11-digit product format
794811001
Labeler code
79481
Product ID
79481-1001_40115ffa-9be6-430c-9fd9-e530686c9ab9
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Meijer
Application
ANDA209995
Marketing category
ANDA
Marketing start
2020-07-15
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
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
79481-1001-2OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION14
79481-1001-2OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.54
79481-1001-4OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.54
79481-1001-4OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-1001OLOPATADINE HYDROCHLORIDE SOLUTION [MEIJER]4Current NDC, Legacy NDC, 4 package rows20220812_d15e4288-c315-48dc-b120-6836a4b4b8c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNd15e4288-c315-48dc-b120-6836a4b4b8c64
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDd15e4288-c315-48dc-b120-6836a4b4b8c64
1111343olopatadine 0.2 % Ophthalmic SolutionSYd15e4288-c315-48dc-b120-6836a4b4b8c64
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYd15e4288-c315-48dc-b120-6836a4b4b8c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79481-1001-2794811001021 BOTTLE, PLASTIC in 1 CARTON (79481-1001-2) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent
79481-1001-4794811001042 BOTTLE, PLASTIC in 1 CARTON (79481-1001-4) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent