FDA.reportPublic FDA data

OLOPATADINE HYDROCHLORIDE

Product NDC
62332-502
11-digit product format
623320502
Labeler code
62332
Product ID
62332-502_fb3ef8a7-46e3-4d8e-83df-117674d1c8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olopatadine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA209420
Marketing category
ANDA
Marketing start
2019-04-29
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [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
62332-502-03OLOPATADINE HYDROCHLORIDE2.5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS2.54
62332-502-03OLOPATADINE HYDROCHLORIDE1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-502-03ML - Milliliter62332-50283d91da2-4a23-495e-8bd6-988c0614853312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-502OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20190508_dbcdf10c-5adb-4d48-97ce-f4b82c6bc77d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNdbcdf10c-5adb-4d48-97ce-f4b82c6bc77d4
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDdbcdf10c-5adb-4d48-97ce-f4b82c6bc77d4
1111343olopatadine 0.2 % Ophthalmic SolutionSYdbcdf10c-5adb-4d48-97ce-f4b82c6bc77d4
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYdbcdf10c-5adb-4d48-97ce-f4b82c6bc77d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-502-03623320502031 BOTTLE, PLASTIC in 1 CARTON (62332-502-03) / 2.5 mL in 1 BOTTLE, PLASTIC2019-04-290000-00-00NoNoCurrent