PATADAY TWICE A DAY RELIEF

Product NDC
0065-4274
11-digit product format
000654274
Labeler code
0065
Product ID
0065-4274_c2f804cb-30d1-40d1-b48e-06889a3e0490
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA020688
Marketing category
NDA
Marketing start
2020-02-25
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
1 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 TWICE A DAY RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111339, 2281304

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
0065-4274-01PATADAY TWICE A DAY RELIEF1 in 1 CARTONSOLUTION16
0065-4274-01PATADAY TWICE A DAY RELIEF5 mL in 1 BOTTLE, PLASTICSOLUTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-4274-01ML - Milliliter0065-4274c117694a-d6ae-4dc6-82ae-d425a409589d12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-4274PATADAY TWICE A DAY RELIEF (OLOPATADINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20231216_b7a24375-25df-4405-aa7c-34c46af51194.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111339olopatadine HCl 0.1 % Ophthalmic SolutionPSNb7a24375-25df-4405-aa7c-34c46af511946
2281304Pataday Twice Daily 0.1 % Ophthalmic SolutionPSNb7a24375-25df-4405-aa7c-34c46af511946
2281304olopatadine 1 MG/ML Ophthalmic Solution [Pataday]SBDb7a24375-25df-4405-aa7c-34c46af511946
1111339olopatadine 1 MG/ML Ophthalmic SolutionSCDb7a24375-25df-4405-aa7c-34c46af511946
1111339olopatadine 0.1 % Ophthalmic SolutionSYb7a24375-25df-4405-aa7c-34c46af511946
1111339olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYb7a24375-25df-4405-aa7c-34c46af511946
2281304Pataday 0.1 % Ophthalmic SolutionSYb7a24375-25df-4405-aa7c-34c46af511946
2281304Pataday 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic SolutionSYb7a24375-25df-4405-aa7c-34c46af511946

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-4274-01000654274011 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) / 5 mL in 1 BOTTLE, PLASTIC2020-02-250000-00-00NoNoCurrent