FDA.reportPublic FDA data

olopatadine hydrochloride

Product NDC
63629-8434
11-digit product format
636298434
Labeler code
63629
Product ID
63629-8434_e659b3d5-5644-4372-a536-5034b9e85621
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olopatadine Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA202853
Marketing category
ANDA
Marketing start
2017-06-14
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
63629-8434-1olopatadine hydrochloride240 in 1 BOTTLESPRAY240108
63629-8434-1olopatadine hydrochloride1 in 1 CARTONSPRAY1108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8434-1GM - Gram63629-8434377ccbf3-d615-4577-8238-c48871f8582e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8434OLOPATADINE HYDROCHLORIDE SPRAY [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 2 package rows20240814_272e8f56-ee4e-456f-ab98-3e40f657c630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797895olopatadine HCl 665 MCG/ACTUAT Metered Dose Nasal SprayPSN272e8f56-ee4e-456f-ab98-3e40f657c630108
1797895olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal SpraySCD272e8f56-ee4e-456f-ab98-3e40f657c630108
1797895olopatadine hydrochloride 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal SpraySY272e8f56-ee4e-456f-ab98-3e40f657c630108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8434-1636298434011 BOTTLE in 1 CARTON (63629-8434-1) / 240 SPRAY in 1 BOTTLE1 bottle2021-04-280000-00-00NoNoCurrent