FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
0363-0869
11-digit product format
003630869
Labeler code
0363
Product ID
0363-0869_4614e8cc-c8e0-4c0f-e063-6394a90a8501
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
WALGREEN COMPANY
Application
ANDA206087
Marketing category
ANDA
Marketing start
2025-12-22
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
0363-0869-01OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53
0363-0869-01OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION13
0363-0869-02OLOPATADINE HYDROCHLORIDE2 in 1 CARTONSOLUTION23
0363-0869-02OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.53

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN26703751-00c4-451b-a5be-242da9cd2b883
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD26703751-00c4-451b-a5be-242da9cd2b883
1111343olopatadine 0.2 % Ophthalmic SolutionSY26703751-00c4-451b-a5be-242da9cd2b883
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY26703751-00c4-451b-a5be-242da9cd2b883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0363-0869-01003630869011 BOTTLE, PLASTIC in 1 CARTON (0363-0869-01) / 3.5 mL in 1 BOTTLE, PLASTIC2025-12-22NoNoHistorical
0363-0869-02003630869022 BOTTLE, PLASTIC in 1 CARTON (0363-0869-02) / 3.5 mL in 1 BOTTLE, PLASTIC2025-12-22NoNoHistorical