FDA.reportPublic FDA data

LEADER OLOPATADINE HYDROCHLORIDE

Product NDC
70000-0716
11-digit product format
700000716
Labeler code
70000
Product ID
70000-0716_32c153a7-d51f-72c5-e063-6294a90aee29
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
CARDINAL HEALTH
Application
ANDA206087
Marketing category
ANDA
Marketing start
2025-04-15
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
LEADER 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
70000-0716-1LEADER OLOPATADINE HYDROCHLORIDE3.5 mL in 1 BOTTLE, PLASTICSOLUTION3.52
70000-0716-1LEADER OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0716-1ML - Milliliter70000-07165eabf2f1-dff5-4e06-a4c3-834fa8c0aa5c12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0716LEADER OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE) SOLUTION [CARDINAL HEALTH]2Current NDC, 2 package rows20250416_71d922d2-22a5-4103-a3eb-126094ee8ef5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN71d922d2-22a5-4103-a3eb-126094ee8ef52
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD71d922d2-22a5-4103-a3eb-126094ee8ef52
1111343olopatadine 0.2 % Ophthalmic SolutionSY71d922d2-22a5-4103-a3eb-126094ee8ef52
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY71d922d2-22a5-4103-a3eb-126094ee8ef52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70000-0716-1700000716011 BOTTLE, PLASTIC in 1 CARTON (70000-0716-1) / 3.5 mL in 1 BOTTLE, PLASTIC2025-04-15NoNoHistorical