FDA.reportPublic FDA data

Olopatadine Hydrochloride

Product NDC
0536-1445
11-digit product format
005361445
Labeler code
0536
Product ID
0536-1445_4b9a07a3-a042-b466-e063-6294a90ab7a2
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RUGBY LABORATORIES
Application
ANDA206046
Marketing category
ANDA
Marketing start
2025-04-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olopatadine Hydrochloride
Listing expiration
2027-12-31

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
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
0536-1445-40Olopatadine Hydrochloride5 mL in 1 BOTTLESOLUTION/ DROPS54
0536-1445-40Olopatadine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1445-40ML - Milliliter0536-1445522d88da-231f-42d0-8932-e6aed9c5530f12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1445RUGBY OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION [RUGBY LABORATORIES]2Current NDC, 2 package rows20250416_96ad3623-f7cc-4c1c-aa65-d89077873b69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSN96ad3623-f7cc-4c1c-aa65-d89077873b694
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCD96ad3623-f7cc-4c1c-aa65-d89077873b694
1111339olopatadine 0.1 % Ophthalmic SolutionSY96ad3623-f7cc-4c1c-aa65-d89077873b694
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSY96ad3623-f7cc-4c1c-aa65-d89077873b694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1445-40005361445401 BOTTLE in 1 CARTON (0536-1445-40) / 5 mL in 1 BOTTLE1 bottle2025-04-15NoNoHistorical