FDA.reportPublic FDA data

Olopatadine Hydrochloride

Product NDC
60505-0845
11-digit product format
605050845
Labeler code
60505
Product ID
60505-0845_312454d0-6465-c4c7-991b-4c4e3bda33c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olopatadine hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA091572
Marketing category
ANDA
Marketing start
2014-10-27
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
665 ug/1
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 HYDROCHLORIDE665 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1797895

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
60505-0845-5Olopatadine Hydrochloride240 in 1 BOTTLESPRAY, METERED24012
60505-0845-5Olopatadine Hydrochloride1 in 1 CARTONSPRAY, METERED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0845-5GM - Gram60505-0845be474037-de46-47f2-8996-132930bbe04712014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Olopatadine HydrochlorideACTIVE INGREDIENT2XG66W44KFOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
OlopatadineACTIVE MOIETYD27V6190PMOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0ROLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0845OLOPATADINE HYDROCHLORIDE SPRAY, METERED [APOTEX CORP.]11Current NDC, Legacy NDC, 2 package rows20240929_3aa27224-7b72-38eb-0c21-b8d73525ee85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797895olopatadine HCl 665 MCG/ACTUAT Metered Dose Nasal SprayPSN3aa27224-7b72-38eb-0c21-b8d73525ee8512
1797895olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal SpraySCD3aa27224-7b72-38eb-0c21-b8d73525ee8512
1797895olopatadine hydrochloride 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal SpraySY3aa27224-7b72-38eb-0c21-b8d73525ee8512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0845-5605050845051 BOTTLE in 1 CARTON (60505-0845-5) / 240 SPRAY, METERED in 1 BOTTLE1 bottle2014-10-270000-00-00NoNoCurrent