Olopatadine Hydrochloride Ophthalmic Solution

Product NDC
11673-688
11-digit product format
116730688
Labeler code
11673
Product ID
11673-688_947ab9c4-3102-bae8-2956-0ff85850956c
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Target Corporation
Application
ANDA209752
Marketing category
ANDA
Marketing start
2021-09-16
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-688OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [TARGET CORPORATION]5Current NDC, Legacy NDC20241204_b233bf3d-e6e6-a724-efd9-389b8e36d2f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 0.2 % Ophthalmic SolutionSYb233bf3d-e6e6-a724-efd9-389b8e36d2f96
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYb233bf3d-e6e6-a724-efd9-389b8e36d2f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11673-688-25116730688251 BOTTLE, PLASTIC in 1 CARTON (11673-688-25) / 2.5 mL in 1 BOTTLE, PLASTIC2021-09-160000-00-00NoNoCurrent
11673-688-50116730688502 BOTTLE, PLASTIC in 1 CARTON (11673-688-50) > 2.5 mL in 1 BOTTLE, PLASTIC2021-10-220000-00-00NoNoCurrent