OLOPATADINE HYDROCHLORIDE

Product NDC
0363-8022
11-digit product format
003638022
Labeler code
0363
Product ID
0363-8022_05bd85c5-75a0-43d2-9273-578eec5e00d3
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
WALGREEN CO.
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 Inhibitor [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
0363-8022-39OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION15
0363-8022-39OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0363-8022-41OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0363-8022-41OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8022OLOPATADINE HYDROCHLORIDE SOLUTION [WALGREEN CO.]5Current NDC, Legacy NDC, 4 package rows20211113_da0f9110-8362-497c-a209-c33a8fa8d995.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNda0f9110-8362-497c-a209-c33a8fa8d9955
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDda0f9110-8362-497c-a209-c33a8fa8d9955
1111343olopatadine 0.2 % Ophthalmic SolutionSYda0f9110-8362-497c-a209-c33a8fa8d9955
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYda0f9110-8362-497c-a209-c33a8fa8d9955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-8022-39003638022391 BOTTLE, PLASTIC in 1 CARTON (0363-8022-39) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent
0363-8022-41003638022412 BOTTLE, PLASTIC in 1 CARTON (0363-8022-41) / 2.5 mL in 1 BOTTLE, PLASTIC2020-07-150000-00-00NoNoCurrent