PATADAY ONCE DAILY RELIEF

Product NDC
0065-0816
11-digit product format
000650816
Labeler code
0065
Product ID
0065-0816_d735b7f6-185e-4fbb-a640-0f8aa8c57f45
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA206276
Marketing category
NDA
Marketing start
2020-09-01
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
7 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 HYDROCHLORIDE7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1601086, 2474007

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
0065-0816-01PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-01PATADAY ONCE DAILY RELIEF2 in 1 CARTONSOLUTION25
0065-0816-02PATADAY ONCE DAILY RELIEF0.5 mL in 1 BOTTLE, PLASTICSOLUTION0.55
0065-0816-02PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION15
0065-0816-04PATADAY ONCE DAILY RELIEF1 in 1 CARTONSOLUTION15
0065-0816-04PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-12PATADAY ONCE DAILY RELIEF2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.55
0065-0816-12PATADAY ONCE DAILY RELIEF3 in 1 CARTONSOLUTION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0065-0816-01ML - Milliliter0065-081667d8c896-9796-4b84-ba8b-04479fa63b4812021-02-05
0065-0816-04ML - Milliliter0065-0816f59821f4-37e3-4ac5-b7d8-7dc76c6d3aeb12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0816PATADAY ONCE DAILY RELIEF (OLOPATADINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]4Current NDC, Legacy NDC, 8 package rows20220626_6d07a5d6-265c-4735-97b3-8a2575b276cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSN6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007Pataday 0.7 % Ophthalmic SolutionPSN6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007olopatadine 7 MG/ML Ophthalmic Solution [Pataday]SBD6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCD6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 0.7 % Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5
2474007Pataday 7 MG/ML Ophthalmic SolutionSY6d07a5d6-265c-4735-97b3-8a2575b276cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0065-0816-01000650816012 BOTTLE, PLASTIC in 1 CARTON (0065-0816-01) / 2.5 mL in 1 BOTTLE, PLASTIC2021-01-040000-00-00NoNoCurrent
0065-0816-02000650816021 BOTTLE, PLASTIC in 1 CARTON (0065-0816-02) / .5 mL in 1 BOTTLE, PLASTIC2021-01-040000-00-00NoNoCurrent
0065-0816-04000650816041 BOTTLE, PLASTIC in 1 CARTON (0065-0816-04) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-010000-00-00NoNoCurrent
0065-0816-12000650816123 BOTTLE, PLASTIC in 1 CARTON (0065-0816-12) / 2.5 mL in 1 BOTTLE, PLASTIC2022-01-240000-00-00NoNoCurrent