FDA.reportPublic FDA data

PATANASE

Product NDC
0065-0332
11-digit product format
000650332
Labeler code
0065
Product ID
0065-0332_b3f44479-9ace-486a-a33e-c5cd0669ee9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olopatadine hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Alcon Laboratories, Inc.
Application
NDA021861
Marketing category
NDA
Marketing start
2008-04-28
Marketing end
2022-08-31
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
600 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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0332-30GM - Gram0065-0332d46c2a24-e777-42bd-a4c3-fa894dd2afe512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLOPATADINE HYDROCHLORIDEACTIVE INGREDIENT2XG66W44KFPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
OLOPATADINEACTIVE MOIETYD27V6190PMPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPATANASE (OLOPATADINE HYDROCHLORIDE) SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797895olopatadine HCl 665 MCG/ACTUAT Metered Dose Nasal SprayPSN24fb7339-f5a9-4d02-a492-43617729412b2
1797898PATANASE 665 MCG/ACTUAT Metered Dose Nasal SprayPSN24fb7339-f5a9-4d02-a492-43617729412b2
1797898olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal Spray [PATANASE]SBD24fb7339-f5a9-4d02-a492-43617729412b2
1797895olopatadine hydrochloride 0.665 MG/ACTUAT Metered Dose Nasal SpraySCD24fb7339-f5a9-4d02-a492-43617729412b2
1797895olopatadine hydrochloride 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal SpraySY24fb7339-f5a9-4d02-a492-43617729412b2
1797898Patanase 0.665 MG/ACTUAT Metered Dose Nasal SpraySY24fb7339-f5a9-4d02-a492-43617729412b2
1797898Patanase 665 MCG/ACTUAT (equivalent to olopatadine 600 MCG/ACTUAT) Metered Dose Nasal SpraySY24fb7339-f5a9-4d02-a492-43617729412b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0065-0332-08000650332081 BOTTLE in 1 CARTON (0065-0332-08) > 8 SPRAY, METERED in 1 BOTTLE1 bottle2008-04-280000-00-00NoNoCurrent
0065-0332-30000650332301 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE1 bottle2008-04-280000-00-00NoNoCurrent