FDA.reportPublic FDA data

olopatadine hydrochloride

Product NDC
16571-882
11-digit product format
165710882
Labeler code
16571
Product ID
16571-882_c23fbb1d-8ba4-4375-aedf-f2346dde7746
Type
HUMAN OTC DRUG
Nonproprietary name
olopatadine hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA204392
Marketing category
ANDA
Marketing start
2025-05-01
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111339

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-882-05olopatadine hydrochloride1 in 1 CARTONSOLUTION12
16571-882-05olopatadine hydrochloride5 mL in 1 CONTAINERSOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-882-05ML - Milliliter16571-8825d27755d-effb-420e-8d18-d73f2f672ec912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-882OLOPATADINE HYDROCHLORIDE SOLUTION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20250501_7c86e2d4-2d37-4ccf-9227-820a50637778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN7c86e2d4-2d37-4ccf-9227-820a506377782
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD7c86e2d4-2d37-4ccf-9227-820a506377782
1111339olopatadine 0.1 % Ophthalmic SolutionSY7c86e2d4-2d37-4ccf-9227-820a506377782
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY7c86e2d4-2d37-4ccf-9227-820a506377782

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-882-05165710882051 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER1 container2025-05-01NoNoCurrent