PATADAY ONCE DAILY RELIEF

Product NDC
0065-8150
11-digit product format
000658150
Labeler code
0065
Product ID
0065-8150_7f324d32-7a86-4976-b0f4-b80283e5fc29
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA021545
Marketing category
NDA
Marketing start
2020-02-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PATADAY ONCE DAILY RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111343, 1111345

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-8150-01PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION17
0065-8150-01PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.57
0065-8150-03PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.57
0065-8150-03PATADAY ONCE DAILY RELIEF2 in 1 CARTONSOLUTION27
0065-8150-04PATADAY ONCE DAILY RELIEF0.5 mL in 1 BOTTLE, PLASTICSOLUTION0.57
0065-8150-04PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION17
0065-8150-07PATADAY ONCE DAILY RELIEF3 in 1 CARTONSOLUTION37
0065-8150-07PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-8150-01ML - Milliliter0065-815068be5c12-f626-4e3d-bb69-eb768db54ff612020-04-20
0065-8150-03ML - Milliliter0065-81503fddb8f6-d8cf-4c04-a531-d07d0224fab212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-8150PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]6Current NDC, Legacy NDC, 8 package rows20231216_1c7d2342-ba1c-4244-9814-d92a05725d4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSN1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111345Pataday Once Daily 0.2 % Ophthalmic SolutionPSN1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111345olopatadine 2 MG/ML Ophthalmic Solution [Pataday]SBD1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCD1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111343olopatadine 0.2 % Ophthalmic SolutionSY1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111345Pataday 0.2 % Ophthalmic SolutionSY1c7d2342-ba1c-4244-9814-d92a05725d4e7
1111345Pataday 2 MG/ML (olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSY1c7d2342-ba1c-4244-9814-d92a05725d4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-8150-01000658150011 BOTTLE, PLASTIC in 1 CARTON (0065-8150-01) / 2.5 mL in 1 BOTTLE, PLASTIC2020-02-280000-00-00NoNoCurrent
0065-8150-03000658150032 BOTTLE, PLASTIC in 1 CARTON (0065-8150-03) / 2.5 mL in 1 BOTTLE, PLASTIC2020-02-280000-00-00NoNoCurrent
0065-8150-04000658150041 BOTTLE, PLASTIC in 1 CARTON (0065-8150-04) / .5 mL in 1 BOTTLE, PLASTIC2020-02-280000-00-00NoNoCurrent
0065-8150-07000658150073 BOTTLE, PLASTIC in 1 CARTON (0065-8150-07) / 2.5 mL in 1 BOTTLE, PLASTIC2021-01-150000-00-00NoNoCurrent